L-05-056, Firstenergy Nuclear Operating Company Requests Authorization to Use Delta Protection Supplied-Air Containment Suits as Respiratory Protection Equipment and Assignment of a Protection Factor, Pursuant to 10CFR20.1703 and 10CFR20.1705

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Firstenergy Nuclear Operating Company Requests Authorization to Use Delta Protection Supplied-Air Containment Suits as Respiratory Protection Equipment and Assignment of a Protection Factor, Pursuant to 10CFR20.1703 and 10CFR20.1705
ML053480357
Person / Time
Site: Beaver Valley, Davis Besse, Perry
Issue date: 12/06/2005
From: Leidich G
FirstEnergy Nuclear Operating Co
To:
Document Control Desk, Office of Nuclear Reactor Regulation
References
3101, L-05-056, PY-CEI-NRR-2839L
Download: ML053480357 (46)


Text

FENOC 76 South Main Street FirstEnergy Nuclear Operating Cmpany Akron, Ohio 44308 -

Gary R. Leidich 330-384-5770 President and Chief Nuclear Officer Fax: 330-384-5669 December 6 , 2005 BV-No. L-05-056 DB-Serial Number 3101 PY-CEI/NRR-2839L United States Nuclear Regulatory Commission Document Control Desk Washington, DC 20555 Beaver Valley Power Station, Unit No. I and No. 2 Docket Nos. 50-334, 50-412 Davis Besse Nuclear Power Station Docket No. 50-346 Perry Nuclear Power Plant Docket No. 50-440 Pursuant to 10CFR20.1703 and I 0CFR20.1705, the FirstEnergy Nuclear Operating Company Requests Authorization to Use Delta Protection Supplied-Air Containment Suits as Respiratory Protection Equipment and Assignment of a Protection Factor Ladies and Gentlemen:

Pursuant to 10CFR20.1703, "Use of Individual Respiratory Protection Equipment," and 10CFR20.1705, 'Application for Use of Higher Assigned Protection Factors," the First Energy Nuclear Operating Company (FENOC) is requesting authorization from the Nuclear Regulatory Commission (NRC) to use a supplied-air containment suit as respiratory protection equipment with an Assigned Protection Factor (APF). Specifically, FENOC is requesting to use the Delta Protection Supplied-Air Containment Mururoa V4 MTH2 Suit, since it has determined that this suit has benefits associated with contamination control, heat stress reduction, and respiratory protection. Since the Delta Protection suit has not been tested or certified by the National Institute for Occupational Safety and Health (NIOSH) nor has an APF assigned, pursuant to I OCFR20.1703(b) and I OCFR20.1705, NRC authorization to use the suits and obtain an APF is required. Additionally, FENOC requests confirmation that the 10CFR20.1703(f) requirement for having dedicated standby rescue personnel to aid personnel from extricating themselves from supplied-air suits would not apply while using Delta Protection suits due to the ease of removal and other features of the Delta Protection suit.

Enclosure I provides the documentation supporting the request. As described in this enclosure, use of the Delta Protection suits would improve worker safety in areas of airborne radioactivity and in areas of high potential for facial/skin contamination from hot particles.

  • .4oDI

December b , 2005 Beaver Valley - L-05-056 Davis Besse - Serial Number 3101 Perry - PY-CEI/NRR-2839L Page 2 of 2 describes the regulatory commitments FENOC has identified for use of the Delta Protection suits.

NRC approval is requested by February 14, 2006. This will allow FENOC plants to implement the procedure changes and complete training necessary for use of the Delta Protection Supplied-Air Containment Mururoa Suits at their facilities prior to the Winter/Spring 2006 refueling outages.

If you have any questions or require additional information, please contact Mr. Gregory A. Dunn, FirstEnergy Nuclear Operating Company, Fleet Licensing Manager, at (330) 315-7243.

Very truly yours,

Enclosures:

1. FirstEnergy Nuclear Operating Company Assessment of Delta Protection Supplied-Air Containment Suits (Enclosure 1 also contains six attachments)
2. Regulatory Commitments cc: NRC Project Manager - Beaver Valley Power Station NRC Project Manager - Davis Besse Nuclear Power Station NRC Project Manager - Perry Nuclear Power Plant NRC Resident Inspector - Beaver Valley Power Station NRC Resident Inspector - Davis Besse Nuclear Power Station NRC Resident Inspector - Perry Nuclear Power Plant NRC Regional Administrator - Region I NRC Regional Administrator - Region IlIl Ms. N. Dragani, Executive Director, Ohio Emergency Management Agency (NRC Liaison)

Mr. D. A. Allaro, Director BRP/DEP Mr. L. E. Ryan, BRP/DEP Utility Radiological Safety Board

Enclosure 1 Beaver Valley - L-05-056 Davis Besse - Serial Number 3101 Perry - PY-CEI/NRR-2839L Page 1 of 6 FIRSTENERGY NUCLEAR OPERATING COMPANY ASSESSMENT OF DELTA PROTECTION SUPPLIED-AIR CONTAINMENT SUITS

1.0 INTRODUCTION

.................................................................. 2 1.1 PURPOSE ................................................................... 2

1.2 BACKGROUND

.................................................................. 2 1.2.1 Regulatory Requirements ................................................................... 2 1.2.2 Suit Construction ................................................................. 3 1.2.3 Safety Features of the Delta Protection Supplied-Air Containment Suit ............. 4 1.2.4 Implementation ................................................................. 4 2.0 TECHNICAL JUSTIFICATION ................................................................... 5 2.1 EVALUATION .................................................................. 5

3.0 REFERENCES

.................................................................. 6 ATTACHMENTS

1. Delta Protection Mururoa V4 Fully Enclosed Suit - General Description
2. Delta Protection/Bacou-Dalloz Supplied Air Containment Suit Brochure
3. European Standard EN 1073-1, 'Protective Clothing Against Radiation Contamination"
4. Institute for Nuclear Protection and Security EC Type Examination Certificate No.

0073/197/162/01/96/0001 (Delta Protection MTH 2 suits)

5. Test Results Carried Out on the Full Encapsulated Suit MTH 2 ref. 841442T For the EC Type Examination Certificate No. 0073/197/162/01/96/0001
6. MTH 2 Instructions For Use

Enclosure 1 Beaver Valley - L-05-056 Davis Besse - Serial Number 3101 Perry - PY-CEI/NRR-2839L Page 2 of 6

1.0 INTRODUCTION

1.1 PURPOSE The table provided in 10CFR20, Appendix A, "Assigned Protection Factors for Respirators," shows that an air-supplied suit may be used in a continuous-flow operating mode; however, an Assigned Protection Factor (APF) is not designated. A footnote to the table for this equipment application indicates that the suit can be used in a respiratory protection program if the minimum program requirements are met pursuant to 10CFR20.1703, "Use of Individual Respiratory Protection Equipment." 10CFR20.1703(b) states that use of equipment not tested or certified by the National Institute for Occupational Safety and Health (NIOSH) equipment is acceptable to limit the intake of radioactive material only if approved for use by the Nuclear Regulatory Commission (NRC). Since 10CFR20, Appendix A does not specify an APF for these air-supplied suits, 10CFR20.1705, "Application for Use of Higher Assigned Protection Factors," would have to be exercised in order to obtain NRC approval for the utilization of an APF not provided by 10CFR20, Appendix A.

The First Energy Nuclear Operating Company (FENOC) has identified the Delta Protection Supplied-Air Containment Mururoa V4 MTH2 Suit as having benefits associated with contamination control, heat stress reduction, and respiratory protection.

These suits have no National Institute for Occupational Safety and Health (NIOSH) approval for use as a respirator to limit the intake of radioactive material in the United States. Therefore, pursuant to 10CFR20.1703(b), FENOC is submitting an application to the Nuclear Regulatory Commission (NRC) for use of equipment that has not been tested or certified by NIOSH to limit worker intakes. Additionally, since the Delta Protection suits do not have an NRC APF, pursuant to 10CFR20.1705, FENOC requests to use an APF of 5000. Due to the ease of removal and other features of the Delta Protection suit, FENOC requests confirmation that the 10CFR20.1703(f requirement for dedicated standby rescue personnel would not apply while using Delta Protection suits to limit the intake of radioactive material.

The Delta Protection Supplied-Air Containment Mururoa V4 MTH2 Suit was approved by the NRC for use at the Callaway Plant, Unit 1 with an APF of 5000 by letter dated September 14, 2005 (TAC NO. MC7242). The Delta Protection suits have been widely used in western European nuclear power plants (the manufacturer indicates that approximately 60,000 Delta Protection suits are used by these plants each year). The suits received certification for use by the Institute for Nuclear Protection and Security (the European certifying agency which is comparable to NIOSH) in 1996.

1.2 BACKGROUND

1.2.1 Regulatory Requirements The following regulatory requirements are relevant to this request.

Enclosure 1 Beaver Valley - L-05-056 Davis Besse - Serial Number 3101 Perry - PY-CEI/NRR-2839L Page 3 of 6 10CFR20.1703, "Use of Individual Respiratory Protection Equipment," states that if a licensee assigns or permits the use of respiratory protection equipment to limit the intake of radioactive material, the licensee shall use only respiratory protection equipment that is tested and certified by NIOSH, except as otherwise noted in this part.

10CFR20.1703(b) states that if the licensee wishes to use equipment that has not been tested or certified by NIOSH, or for which there is no schedule for testing or certification, the licensee shall submit an application to the NRC to authorize use of the equipment.

10CFR20.1703(f) requires the use of a standby rescue person whenever one-piece air-supplied suits are used which an unaided person would have difficulty extricating himself or herself from.

10CFR20.1705, 'Application for Use of Higher Assigned Protection Factors," requires that a licensee shall obtain authorization from the NRC before using assigned protection factors in excess of those specified in 10CFR20, Appendix A.

I OCFR20, Appendix A, "Assigned Protection Factors for Respirators," Item II, "Atmosphere Supplying Respirators (particulate, gases and vapors)," indicates that for a suit in a continuous flow operating mode, no APF is assigned nor is a NIOSH approval schedule currently available for the evaluation of such suits. This equipment may be used in an acceptable respiratory protection program as long as all the other minimum program requirements, with the exception of fit testing, are met.

1.2.2 Suit Construction The Delta Protection Supplied-Air Containment Suit meets Intemational Organization for Standardization (ISO) 8194, "Radiation Protection - Clothing for Protection Against Radioactive Contamination - Design, Selection, Testing, and Use" and the European Standard EN 1073-1, "Protective Clothing Against Radiation Contamination."

The Delta Protection suits have the following desirable features:

  • One-piece construction, that includes integral gloves and booties,
  • Vinyl acetate or polyethylene material with reinforced elbows, knees and crotch areas,
  • Dual zippers - metal zipper inside and plastic zipper outside,
  • Clear Poly Vinyl Chloride (PVC) helmet that provides distortion-free vision,
  • Welded sleeve to insert communication cable,
  • A removable strip near the mouth that could be used for emergency breathing in case of loss of supplied air,
  • An egress strip stretching from left wrist, over the head, to right wrist that is used for undressing and for self-rescue in an emergency, such as loss of supplied air,

Enclosure 1 Beaver Valley - L-05-056 Davis Besse - Serial Number 3101 Perry - PY-CEI/NRR-2839L Page 4 of 6

  • Air intake located at the waist with a built-in regulator that can adjust, but not block, airflow,
  • Two exhaust valves that ensure the suit remains airtight should an event block/pinch the air supply line,
  • Low noise level,
  • Air flow to arms, legs, and face.

Air hoses of any length can be used, but air shall be supplied to the Delta Protection suits at 85 psig i 10% measured at the inlet. A regulator at the inlet is used to adjust the airflow. To ensure user safety, the regulator cannot shut off the air supply. There are two patented exhaust valves on the back of the suit - one behind the neck and one at the lower back. The exhaust valves prevent any aspiration of contaminants if supplied air is lost. The Delta Protection suit is approved for use with 16 different fittings in Europe and can be fitted with Schrader or Foster or CEJN type fittings used at the FENOC facilities.

1.2.3 Safety Features of the Delta Protection Supplied-Air Containment Suit In addition to the features described in Section 1.2.2, above, the Delta Protection Supplied-Air Containment Suit is lightweight (approximately 2 Ibs), and is available with a fire-retardant treatment. The Institute for Nuclear Protection and Security (IPSN) certifies the suit has the appropriate resistance to abrasion, flex cracking, puncture, tearing, and flammability. The noise level at maximum airflow is less than 80 dB.

Airflow can be adjusted by the user for his/her comfort, but cannot be shut off. In case of loss of air, the user can remove the mouth strip and move the opening close to the face, or enlarge the opening to breathe outside air. Alternately, the user can pull the escape strip from either forearm, over the head and towards the other forearm, and rip the suit in two halves.

The Delta Protection suit's design does not permit its use in an Immediately Dangerous to Life and Health (IDLH) atmosphere. FENOC will use this suit for protection against radioactive particulate contamination, and will not allow use in an IDLH atmosphere.

1.2.4 Implementation FENOC currently uses air-supplied hoods (commonly known as bubble hoods) for jobs involving overhead-contaminated water or high potential for skin contamination from discrete radioactive particles. Because the bubble hoods do not cover the hands or feet, workers have to wear additional protective clothing to minimize potential skin contaminations. The Delta Protection suits offer a better alternative (with their unitized construction and ease of removal) and would protect the worker much better against facial/skin contamination and airborne radioactivity than the bubble hoods currently in use. Use of the Delta Protection suits would assist in FENOC's efforts to control contamination incidents and to prevent intakes during operational activities at all FENOC facilities.

Enclosure I Beaver Valley - L-05-056 Davis Besse - Serial Number 3101 Perry - PY-CEI/NRR-2839L Page 5 of 6 The Delta Protection suits will be integrated into the FENOC radiological respiratory protection programs using the manufacturer's recommendations. New lesson plans will be developed to train workers on the Delta Protection suit features, donning, use and removal, and use of mouth strip, and tear off strips for routine and emergency egress.

Radiation Protection personnel will be provided additional training for selection, approval, issue, equipment set-up, operation, and maintenance instructions for the Delta Protection suit.

The Delta Protection suits will be discarded after a single use. Any defects discovered would be entered into the FENOC Corrective Action Program and reported to the manufacturer.

2.0 TECHNICAL JUSTIFICATION 2.1 EVALUATION FENOC conducted an in-house inspection and demonstration of the suits. This inspection/demonstration indicated that the Delta Protection suits are an improvement over the currently used bubble hoods due to their ease in donning and removal.

FENOC also reviewed the following documents obtained from Delta Protection:

  • Delta Protection Mururoa V4 Fully Enclosed Suit - General Description (Attachment 1),
  • Delta Protection/Bacou-Dalloz Supplied Air Containment Suit Brochure (Attachment 2),
  • European Standard EN 1073-1, "Protective Clothing Against Radiation Contamination" (Attachment 3),
  • Institute for Nuclear Protection and Security EC Type Examination Certificate No. 0073/197/162/01/96/0001 (Delta Protection MTH 2 suits) (Attachment 4),
  • Test Results Carried Out on the Full Encapsulated Suit MTH 2 ref. 841442T For the EC Type Examination Certificate No. 0073/197/162/01/96/0001 (Attachment 5), and
  • MTH 2 Instructions For Use (Attachment 6).

Based on a review of this documentation and the in-house inspection, the suits represent a better design than the currently approved bubble hood and provide better worker protection, with the data supporting an APF of at least 5000.

A key element of this review was the application of the European Standard and the Certificate issued by the Institute for Nuclear Protection and Security for the Delta Protection suits. The European Standard (Attachment 3) requires that the suit satisfy requirements associated with resistance to abrasion, flex cracking, puncture, blocking, tear and flammability, strength of seams, joins and assemblies, damage resistance of exhaust valves, designed flow rates for pressure range of supplied air, noise level, and

Enclosure 1 Beaver Valley - L-05-056 Davis Besse - Serial Number 3101 Perry - PY-CEI/NRR-2839L Page 6 of 6 quality of the visor. According to the testing standard, two workers should perform standard tests to determine the practicality of the suit. Standard tests include walking at a rate of 5 km/hr for 5 minutes and loading a bucket of chips from the base of a hopper and emptying it into the opening on top of the hopper repeated 15 - 20 times in 10 minutes. Additionally, a protection factor for the suit is determined. The testing standard requires two individuals to test two separate suits in a test chamber filled with sodium chloride.

The testing methodology includes the performance of a variety of exercises during the test. Certificate No. 0073/197/162/01196/0001 (Attachment 4) states that the Delta Protection suit passed in all categories tested and provided a fit factor of 50,000 (note, the certificate converts the protection factor determined during testing to a fit factor). It should be noted that the term 'fit factor' used in the European Certificate is not the same as the Assigned Protection Factor used in 10CFR20; however, the testing associated with the granting of the Certificate supports the assignment of an Assigned Protection Factor (APF) of 5000 which is 10% of the documented fit factor. This APF is identical to the one granted to the Callaway Plant in September 2005 (TAC NO. MC7242).

The Delta Protection suit's safety features, namely the tear-off mouth strip and the emergency tear-off strip, which allows the suit to be removed in less than 5 seconds, make the assignment of standby rescue personnel unnecessary.

3.0 REFERENCES

1. 10CFR20.1703, "Use of Individual Respiratory Protection Equipment"
2. 10CFR20.1705, "Application for Use of Higher Assigned Protection Factors"
3. 10CFR20, Appendix A, 'Assigned Protection Factors for Respirators"
4. European Standard EN 1073-1, "Protective Clothing Against Radiation Contamination"
5. Institute for Nuclear Protection and Security EC Type Examination Certificate No. 0073/197/162/01/96/0001 (Delta Protection MTH 2 suits)
6. NRC letter to Union Electric Company dated September 14, 2005, "Callaway Plant, Unit 1 - Use of Delta Protection Respiratory Protection Equipment (TAC No.

MC7242)," (ADAMS Accession No. ML052570106)

Enclosure 1, Attachment 1 Beaver Valley - L-05-056 Davis Besse - Serial Number 3101 Perry - PY-CEI/NRR-2839L Delta Protection Mururoa V4 Fully Enclosed Suit General Description

N0: Do/ USA/ 1 MURUROA INDICE: a V4 FULLY ENCLOSED SUIT DATE D'APPLICATION :06/09/01 GENERAL DESCRIPTION DELTAC04PROTECTIOA 66 8918 36 PAGE :1/4 MURUROA SUIT The Mururoa suit is a single use garment designed to be used in radioactively contaminated environments. It has been widely used in western European Nuclear Power Plants for more than 20 years, without any major problem (the French state company: ElectricitM de France use 60,000 garments each year).

The Mururoa suit is a fully enclosed PVC plastic, supplied-air and pressurized suit, that offers excellent protection factor ( -100,000) against any solid, liquid, or gas pollutant, minimizing discomfort and heat stress and increasing the workers efficiency.

The Mururoa suit is C.E. approved and complies with CE standard EN:1073-1 "Protective clothing against Radioactive Contamination" It also fulfils the requirements of the I.S.O. 8194 standard "Radiation Protection-Clothing for protection against Radioactive contamination-Design selection ,testing and use"

NO: Do/USA/I MURUROA INDICE: a V4 FULLY ENCLOSED SUIT DATE :DELTA PROTECTIOA DATE DAPPLICATION :06/09/01 GENERAL DESCRIPTION CD 04 66 89 18 36 PAGE :2/4 VENTILATION / EXHAUST In the supplied-air Mururoa suit, the ventilation system is composed of

- An airflow control valve, preset to a minimum flow of 250 litres/minute (9 CFM) at 3 bar (42 PSIG), located on the right hip and covered with a protection flap. This flow can be adjusted, from 250 to 1150 litres (9 CFM to 41 CFM) per minute. 1150 litres is obtained with the tap fully opened at the feeding pressure of 6 bar (85 PSIG) (refer to graph in annex 11).

- A silencer bag which attenuates the noise level less than 58 dBa at 250 litres/minutes to 76 dBa at 1150 litres/minute.

- A manifold system welded to the suit and distributing the air to the helmet, the legs and the arms.

- An exhaust by two world patented valves placed in the helmet and in the back. These valves ensure a remarkable airtight seal in case of accidental air-feed cut off, or when putting the suit in under pressure through abrupt movements. The valves regulate the overpressure in the garment between 3 mbar (0.042 PSIG) and 10 mbar (0. 142 PSIG) for supply air pressure between 3 bar (42 PSIG) and 6 bar (85 PSIG)

- The benefits of this system are

- High heat removal through superior airflow

- Non irritating diffuse ventilation

- Resistance free breathing

- High level of comfort for long and strenuous jobs in contaminated areas

- Very low noise level

V i9 N0: Do/ USA/ 1

__INDICE: a MURUROA V4 FULLY ENCLOSED SUIT A A

DATE D'APPLICATION :06/09/01 GENERAL DESCRIPTION DELTACD04PROTECTION~

66 8918 36 PAGE :3/4 DESIGN CHARACTERISTICS

- One piece PVC, fire proof suit. (Thickness 20/100mm for technical data concerning the material, refer Annex I of this document)

- Welded PVC gloves

- Incorporated overboots with strengthened sole

- Binding ties on the overboots

- Reinforced elbows, knees and crotch

- Dual zipper system: - metal zipper for mechanical strength

- PVC zipper for air and gas tightness (0.30 PVC thickness)

- Supple transparent PVC helmet, fitted with a transparent distortion free, PVC face plate 6"x 8" giving almost the same optical quality as glass.

- Quick release strip from forearm, overhead to forearm, for easy removal. This is used both for undressing or emergency egress. (Emergency egress takes less than 3 seconds).

- Quick release strip for access to the mouth.

- Welded sleeve for communication cable.

0*

N0: Do/ USA/ 1 MURUROA as INDICE: a V4 FULLY ENCLOSED SUIT DATE D'APPLICATION :06/09/01 DELTA PROTECTIOA GENERAL DESCRIPTION C 04 66 8918 36 PAGE :4/4 GENERALCONSIDERATIONS THE MURUROA SUIT IS AVAILABLE IN SIX SIZES Size 0 1,55 m e 1,62 meter 5 feet I inch -4 5 feet 4 inches Size 1 1,60 -4 1,68 meter 5'3" - 5'6" Size 2 1,68 -* 1,74 meter 5'6" - 5'8" Size 3 1,74 -4 1,82 meter 5'8" e 6'0" Size 4 1,82 - 1,92 meter 6'0" - 6'3" Size 5 1,92 -4 2,05 meter 6'3" 68" But if any individual selects a suit size different from the recommended size, the operating and safety characteristics will not change.

WEIGHT 1200 grams (2.64 LBS)

FEEDING PRESSURE 6 bar (85 PSIG)

FLOW 450 up to 1150 Lit/minute (16 - 41 CFM)

STORAGE

- The suit should be used by the third year from the date of manufacture.

- It must be stored in its original packaging.

- The storage temperature has to stay between 0C and 600C (320F - 140*F)

- If the storage temperature was below 50C (410F) the suit must be stored approximately 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> at a room temperature until the suit become flexible.

- The usage temperature range + 5° C and + 550C (41° - 1310F) depends on air fed temperature

b A

N0: Do/USA/1 MURUROA f&

INDICE__ a V4 FULLY ENCLOSED SUIT DATE DAPPLICATION :06/09/01 GENERAL DESCRIPTION DELTAT 04PROTECTIA 66 89 18 36 PAGE :5/4 MATERIAL PROPERTIES Technical characteristic of PVC material 20/100 mm using French standards, which would correspond to ANSI standards.

Characteristic Standards Results Units Density NFT 51063 1.38 gm/cm3 Traction Resistance NFT 54102 2 143 N/cm2 Stretch before tear NFT 54102 2 178  %

Tear resistance NFT 46007 2 45 N/cm2 Weld resistance than material resistance NFT 54122 Peel 50 lTear 65  %

Resistance to cold NFT 51102 -10 0C Vapour permeability NFH 00030 34.1 g/m2/24h Volatility on activated charcoal NFT 51167 <6 No Spark perforation NFC 26225 9.2 KV

w U.

Enclosure 1, Attachment 2 Beaver Valley - L-05-056 Davis Besse - Serial Number 3101 Perry - PY-CEI/NRR-2839L Delta Protection/Bacou-Dalloz Supplied Air Containment Suit Brochure

-~ _^ zA, '

Supplied Air Containment Suit Bacou-Dalloz DELTA PROTECTION DESCRIPTION Encapsulating, one-piece, single/multi use, supplied-air, positive pressure containment suit with either remote or portable ventilation. This suit is ideally suited for manufacturing or lab workers working with potent active ingredients.such as in the pharmaceutical industry, or wherever the individual is faced with the risk of contamination. unprotected workers pose considerable occupational health risks.

FEATURES & BENEFITS Materials & Design Ideal for use in pharmaceutical applications requiring superior respiratory protection along with full body dermal protection and metabolic heat stress reduction.

  • Durable chemical resistant PVC, or vinyl acetate (available With fire-retardant treatment).

-Vinyl acetate suit can be incinerated.

  • Reinforced elbows, knees and'crotchlfor increased durability.
  • Dual zipper system - metal zipper plus a PVC zipper- provides mechanical strength and gas and liquid impermeability.
  • Transparent PVC hood with distortion-free visor gives 180 degree field of vision.

Ventilation

  • Air flow is user selectable from 19 to 43 cfm to adapt to different cooling and breathing needs.
  • integrated manifold system distributes air throughout the suit to remove metabolic heat and keep you copol as well as preventing the visor from fogging.
  • Manifold system maintains low noise levels: <55 dBa at 19 cfm.
  • Two patented exhaust valves eliminate the possibility of entry of airborne contaminants in case of loss of supplied air or if certain body movements create a.

sudden negative pressure. Mururoa V4 F1 Comfort and Eas'e of Use

  • Ease of donning and doffing.
  • Available with portable fan and filters for situations, where a supplied-air line is impractical.
  • Integrated anti-slip overshoes and PVC gloves make suiting up easier and eliminate potential leakage points. This is a no compromise fully encapsulating system approach to protection, and comfort.

I *Available in six sizes.

  • Lightweight (32 oz). This suit moves with you in order to maximize mobility.

Respiratory Protection

  • Air-borne Protection Factor in excess of 80,000 for flow-rates from 20CFM to 43 CFM
  • . Certified to EN 1073-1 Class 5 PF > 50,000.

Safety Features

  • One to three minutes of breathable air in the suit in case of failure of air supply.

MTH 2 b 'Tear-g ~running from wrist to wrist permits emergency doffing of suit in less than 6 seconda well as easy removal of the suit preventing cross contamination.

Tear-a rip infront of the m:outh permits emergency breathing.

"I Approvals

  • Has been tested and certified to EN 1073-1 'Supplied air suits for protection against Contamination"..
  • Application tested in a varietv of oharmaceutical hiah Dotent aoolications.

Enclosure 1, Attachment 3 Beaver Valley - L-05-056 Davis Besse - Serial Number 3101 Perry - PY-CEI/NRR-2839L European Standard EN 1073-1, "Protective Clothing Against Radiation Contamination"

EUROPEAN STANDARD EN 1073-1 NORME EUROPEENNE EUROPEAISCHE NORM January 1998 ICS 13.280; 13.340.10 Descriptors: Personal protective equipment, clothing, radioactive contamination.

English version Protective clothing against radioactive contamination Part 1: Requirements and test methods for ventilated protective clothing against particulate radioactive contamination VWtements de protection contre la Schutzkleidung gegen radioaktive contamination radioactive - Partie 1: Kontamination -Teil 1: Anforderungen Exigences et methodes d'essai des und Priifverfahren fur beliiftete vOtements contre la contamination Schutzkieidung gegen radioaktive radioactive sous forme de particules Kontamination durch feste Partikel This European Standard was approved by CEN on 1997-11-23. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member.

The European Standards exist in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom.

CEN European Committee for Standardization Comite Europeen de Normalisation Europaisches Komitee fur Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels O1998. CEN - All rights of exploitation in any form and by any means Ref. No. EN 1073-1 :1998 E reserved worldwide for CEN national members.

I Page 2 EN 1073-1 :1998 Contents Foreword ....................................................... 2 I Scope ....................................................... 3 2 Normative references ................. .3 3 Definitions ........................................................ 3 4 Requirements ........................................................ 4 5 Test methods ....................................................... 8 6 Marking ....................................................... 10 7 Information supplied by the manufacturer ............................................... 10 Annex A (normative)

Activity sequence for the testing of the protection factor ........................... 11 Annex ZA (informative)

Clauses of this European Standard addressing essential requirements or other provisions of EU Directives ....................... ................................ 12 Foreword This European Standard has been prepared by Technical Committee CEN/TC 162 "Protective dothing including hand and arm protection and lifejackets", the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by July 1998, and conflicting national standards shall be withdrawn at the latest by July 1998.

This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an Integral part of this standard.

The annex A is normative and contains the activity sequence for the testing of the protection factor.

Further parts of this standard will deal with requirements and test methods for unventilated protective clothing and protection against liquids and gases.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

Page 3 EN 1073-1:1998 1 Scope This European Standard specifies the requirements and test methods for ventilated protective clothing protecting the wearer against particulate radioactive contamination.

This European Standard does not apply for the protection against ionizing radiation and the protection of patients against contamination with radioactive substances by diagnostical and/or therapeutical measures.

2 Normative references This European standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies.

EN 146 Respiratory protective devices - Powered filtering devices incorporating helmets or hoods - Requirements, testing, marking EN 270 Respiratory protective devices - Compressed air line breathing apparatus incorporating a hood - Requirements, testing, marking EN 340 Protective clothing - General requirements EN 530 Abrasion resistance of protective clothing material - Test methods EN 863 Protective clothing - Mechanical properties - Test method: Puncture resistance prEN 943-1 Protective clothing for use against liquid and gaseous chemicals, including liquid aerosols and solid particles -

Performance requirements for ventilated and non-ventilated 'gas-tight' (Type 1) and "non-gas-tight" (Type 2) protective clothing EN1 146 Respiratory protective devices for self-rescue - Self-contained open-circuit compressed air breathing apparatus incorporating a hood (compressed air escape apparatus with hood) - Requirements, testing, marking EN 25978 Rubber- or plastics- coated fabrics - Determination of blocking resistance (ISO 5978: 1990)

EN 29073-4 Textiles - Test methods for nonwovens - Part 4: Determination of tear resistance ISO 5082: 1982 Textiles - woven fabrics - Determination of breaking strength - Grab method ISO 7854 Rubber- or plastics-coated fabrics - Determination of resistance to damage by flexing 3 Definitions For the purposes of this standard, the following definitions apply:

3.1 Protective clothing against radioactive contamination Protective clothing intended to provide protection to the skin and if required to the respiratory tract against radioactive contamination.

Page 4 EN 1073-1 :1998 3.2 Ventilated protective clothing (against particulate radioactive contamination)

Protective clothing which is supplied with breathable air ensuring internal ventilation and overpressure. This protective clothing provides protection against particulate radioactive contamination for the respiratory tract and the whole body.

3.3 Nominal protection factor (100: inward leakage (IL))

The ratio of the concentration of contaminant inthe ambient atmosphere to the concentration of the contaminant inthe suit. The concentrations taken into account are the average concentrations recorded during a standardized test.

3.4 Paniculate radioactive contamination Presence of radioactive substances in or on a material or ina place where they are undesirable or could be harmful.

3.5 Seam A permanent fastening between two or more pieces of protective clothing material.

3.6 Assemblage A permanent fastening between two or more different garments, or between protective clothing and accessories, obtained, for example by sewing, welding, vulcanising, gluing.

3.7 Join A non-permanent fastening between two different garments, or between protective clothing and accessories.

3.8 Closure A device, for example, zipper, "touch and close" fastener, etc., to close openings for donning or removing the protective clothing.

4 Requirements 4.1 Design 4.1.1 Protective clothing against radioactive contamination shall comply with the general requirements specified in EN 340.

4.1.2 The design of the protective clothing shall be such that the protective clothing is straightforward to put on and take off, and to minimize the risk of contamination. Testing according to "practical performance test' (see 5.2).

4.1.3 The clothing can be designed for single or multiple use.

4.1.4 The ventilated protective clothing (see 3.2} may consist of one or several parts. The clothing may be fitted with a respiratory protective device to enable the wearer to breath in case of failure of the primary air supply.

4.2 Materials The materials used for protective clothing against particulate radioactive contamination shall meet the requirements according to table 1 after the pretreatment In accordance with 5.1.1 and after the conditioning according to 5.1.2.

Page 5 EN 1073-1 :1998 Table 1: Requirements for the materials Applicable for Requirement Classification Test according to reusable single use nmaterials 6 > 2000 Cycles EN 530, Method 2 00 5 > 1 500 Cycles abrasive paper Abrasion 4> 1500 Cycles according to prEN 943- yes yes resstnc 3> 500 Cycles I and 9 kPa downward 2 > 500 Cyclespressure 1> 10 Cycles 6 > 100000 Cycles 5 > 40000 Cycles Flex cracking 4 > 1 5000 Cycles ISO 7854 Method B yes no resistance 3> 5000 Cycles 2> 2500 Cycles I > 1000Cydes Puncture 3> 100 N 2> SO N EN 863 yes yes resistance 1> 1ON Resistance to 2 no blocking EN 25978 yes no blocking (see note 1) 1 blocking 6> 150N 5> 80N Tear resistance 4> 40 N EN 29073-4 yes yes 2> 1ON 1> 2N Flammability' of Shall not continue to EN 1146 (single materials, visor and bum burner test) yes yes ancillary parts NU t 1: uncoated materials snail not De tested against resistance to DIocKing. I he test report shall be marked "Not tested against ..........

NOTE 2: If protection against hazardous chemicals is required then testing has to be carried out according to the relevant chemical standards.

4.3 Nominal protection factor (100:1L)

Ventilated protective clothing shall be classified according to table 2. Testing according to 5.4 with the necessary activity sequence according to annex A, at the minimum design air flow rate.

Page 6 EN 1073-1 :1998 Table 2: Leakage Class Maximum value of mean Inward leakage into the Nominal protection hood during exercise of factor One activity All activities 5 0,004 0,002 50000 4 0,01 0,005 20000 3 0,02 0,01 10000 2 0,04 0,02 5000 1 0,10 0,05 2000 NOTE 1: Maximum value is calculated as the average performance over all test sequences. NOTE 2: Nominal protection factor is the reciprocal of the IL obtained during all activities (100: IL) 4.4 Seam strength, Joins and Assemblages 4.4.1 Seam strength A sample of each type of straight seam construction shall be tested in accordance with A.2 of ISO 5082

1982 (Constant-rate-of-traverse). Three specimens of each type of seam shall be tested and the mean of each set of three samples calculated. The garment seam performance shall be classified according to the levels of performance given in table 3 using the lowest result, i.e. the weakest seam type.

NOTE: The test method described in ISO 5082: 1982 is only applicable to straight seams Joining two pieces of material.

Table 3: Classification of seam strength Class C___ ___

Seam strength N

5 >300 4 >125 3 > 75 2 >50 11 >30 4.4.2 Joins and assemblages The Joins and assemblages between the suit and detachable parts e.g. between gloves and sleeves, boots and trouser legs, shall be tested in accordance with 5.5 and withstand a pull of 100 N.

4.5 Visor The visor shall comply with table 4. Where antifogging compounds are used or specified by the manufacturer they shall not have an adverse affect on the health of the wearer, or on the clothing.

Page 7 EN 1073-1 :1998 Table 4: Requirements for the visor Properties of the visor Requirement Testing the loss of sight shall not exceed to read letters on a chart at a Distortion of vision two scales on the optometrical distance of 5 m during the practical chart performance test according to 5.2 shall not be visibly damaged In Mechanical strength such a way as to be likely to affect according to EN 146 the performance of the suit system 4.6 Air supply system Couplings and connections shall comply with EN 270.

The connection between the compressed air supply tube and the suit, including attachments, threaded parts, belt or other parts, or means of stabilising the suit to the body shall withstand a 250 N pull when tested according to 5.5.

NOTE: The test should be performed before the Inward leakage test.

4.7 Breathing hose The breathing hose shall comply with the requirements of EN 270.

4.8 Air flow rate Two suit systems shall be tested, one of which has to be preconditioned as specified in 5.1.4. When tested the air flow rate into the suit system shall not be less than the manufacturers' minimum design flow rate. The maximum flow rate shall not exceed the maximum as stated by the manufacturer. Test in accordance with 5.3 The flow rate and the distribution of the air into the suit system shall not cause distress to the wearer by local cooling. The heat stress has to be considered. Test in accordance with 5.2.

4.9 Air flow rate warning device If an audible warning device is incorporated in the suit system it shall comply to EN 270, except for the sound pressure level which may be in the range 85dB(A) to 90 dB(A) when measured at the ears of the wearer. The frequency range of the warning device shall be between 2 000 Hz to 4 000 Hz.

Five warning devices shall be tested, one of which has to be preconditioned as specified in 5.1.4. Testing according to EN 270.

4.10 Supply valve If a variable continous flow valve is fitted, it shall comply to EN 270. The valve shall permit to adjust the air flow rate in the range from the minimum to the maximum as specified in 4.8. It shall not be possible to close the valve to restrict the air flow below the minimum design air flow rate.

4.11 Exhaust devices The suit shall be provided with exhaust devices which shall continue to work correctly after the testing of the pressure in the suit (see 4.1 2), during the practical performance test (see 5.2) and during the determination of the protection factor (see 5.4). Testing in accordance with 5.6.

4.12 Pressure in the suit The overpressure shall not exceed 1 000 Pa mean and 2 000 Pa peak. A positive pressure shall be maintained.

Testing with the maximum air flow rate during the activity sequence as specified in Annex A.

4.13 Carbon dioxide content of the inhalation air The carbon dioxide content of the inhalation air, determined at the minimum air flow rate, shall not exceed an average of 1,0 % (by volume), tested according to EN 270. Two suits shall be tested, one of which has to be pretreated as specified in 5.1.1.

Page 8 EN 1073-1: 1998 4.14 Noise associated with the air supply to the suit The noise measured in the suit at the ears shall not exceed 80 dB(A) at the maximum manufacturers' design flow rate. Testing in accordance with EN 270. Two suits shall be tested, one of which has to be pretreated as specified in 5.1.1.

5 Test methods 5.1 Test preparations 5.1.1 Pretreatment When the clothing is intended to be reusable the requirements for the materials or the complete clothing shall be proved after five cycles of cleaning and disinfection according to the manufacturer's instructions for use before testing.

5.1.2 Conditioning All material samples shall be conditioned by storage at (20 i 2) 'C and (65 +/- 5) % relative humidity for at least 24 h. Start each of the tests as specified in 5.1.3 and 5.1.4, within 5 min after removal from the conditioning atmosphere.

5.1.3 Visual inspection A visual inspection shall be carried out by the test house prior to the laboratory or the practical performance test. This may entail a certain amount of dismantling of the components of the protective clothing in accordance with the manufacturer's information for maintenance.

5.1 .4Preconditioning for the practical performance test If the manufacturer does not state the preconditioning atmosphere for the practical performance test, the complete clothing shall be exposed:

a)for 4 h to a temperature of (-30 +/- 3) "C and allowed to return to ambient conditions, followed by b)for 4 h to an atmosphere of (60 +/- 3) AC at 95 % relative humidity. It shall then be allowed to return to ambient temperature.

5.2 Practical performance test 5.2.1 General The tests shall be carried out by two test persons at (20 +/- 5) "C and a relative humidity of less than 60 %. The test temperature and humidity shall be recorded. The background noise shall not be greater than 75 dB(A).

The test persons shall be selected who are familiar with using such or similar protective clothing. The persons will be drawn from those people certified as fit to do so by the medical officer. The necessity of a medical examination before or supervision during the tests shall be at the testing officers discretion.

Prior to the test there shall be an examination that the suit is in working-condition and that it can be used without danger. If more than one size of clothing is manufactured the subjects are asked to select the appropriate size. Ensure that the air supply is within the specified parameters. Two suits shall be tested, each being tested on one test person.

After fitting the suit each test person is asked "Does the suit fit?". If the answer is "Yes", continue the test. If the answer is "No", replace the test person or the suit.

5.2.2 Procedure During the test the following activities shall be done in simulation of the practical use of the suit:

a) the test shall be completed within a total working time of 20 min b) walking on the level with regular rate of 5 km/h for 5 min

Page 9 EN 1073-1 :1998 c) filling a small basket (see figure 1, approximate volume 8 I) with 12 mm chippings (e.g. limestone chippings) or other suitable material from a hopper which stands 1.5 m high and has an opening at the bottom to allow

-the contents to be shovelled out and a further opening at the top where the chippings may be returned. The person stoops or kneels as he wishes and fills the basket with chippings. He then lifts the basket and empties the contents back into the hopper. This shall be repeated 1 5 to 20 times in 10 min .

Figure 1: Hopper and basket 5.2.3 Information to be recorded During the practical performance test the clothing shall be subjectively assessed by the wearer and the following shall be recorded:

a)harness comfort (see 5.6);

b)security of fastening and couplings; c) accessibility of controls and pressure gauge (if fitted);

d) clarity and field of vision from the facepiece and/or visor; e)clothing comfort; f) ease of speech transmission; g)any other comments volunteered by the wearer.

5.3 Measurement of minimum and maximum air flow rate Connect the ends of the distribution system collectively to a suitable measuring device. Record the maximum air flow delivered at the manufacturers' specified air supply, if a control valve is fitted, record the maximum delivered air flow and the minimum delivered air flow.

The value of minimum and maximum air flow rate shall be determined under the condition of exercise 6 of Annex A (person standing still).

5.4DetermInation of the protection factor The protection factor shall be determined in accordance with prEN 943-1. Sodium chloride test method shall be used. Activity sequences for testing are given in Annex A of this standard.

The determination has to be done at the minimum design air flow rate (see 4.8).

On two test subjects four new suits shall be tested. Two suits per test subject.

Page 10 EN 1073-1 :1998 For each individual test calculate the arithmetic mean over the time period. Calculate the percentage inward leakage (IL) as follows: -

IL= Cox 100%

Cl where:

C, is the challenge concentration in the test chamber, C2 is the mean concentration in the breathing zone for each exercise. For classification according to table 2, the average value for the four suits shall be taken.

5.5 Join and assemblage pull test Assemble the means of attachment according to the manufacturers' information. If the assembled item (e.g.

glove or boot) is itself not strong enough to apply the required pull substitute an item that is. Securely attach one part to a fixed clamp. Apply the required force longitudinally. Record at which force it parts or state that at the required force it was still complete.

5.6 Exhaust device pull test Mount the suit on to a dummy torso which can be adjusted so that the load can be applied axialiy to the exhaust device. A system of retaining straps or bands is fitted over the suit around the exhaust device so that the load is applied as directly as possible to the fitting of the exhaust device in the suit.

Exert a force of (50 i 2,5) N to the exhaust device and hold for 10 s. Repeat 10 times.

Examine the exhaust device for signs of damage or failure.

6 Marking The marking shall comply with the specifications of EN 340 with the pictogram as given infigure 2.

The level of performance of the inward leakage (IL) shall be marked as:

IL: class x (x = class number according to table 2).

  • e* S°e 4 E5 E *.*
  • *' *0 Figure 2: Pictogram 7 Information supplied by the manufacturer The information supplied shall be at least in the official language(s) of the country or region of application. The manufacturers' information shall comply with the specifications of EN 340. The following information shall be supplied additionally:

- instructions for donning, using, fitting, removing and storing;

- application, limitations of use (classification, temperature range etc.);

- tests to be carried out by the wearer before use (if required);

- maintenance and cleaning and decontamination by e.g. showering (if required).

The manufacturers shall specify the required supply pressure and flow range necessary to maintain protection.

Warnings (if appropriate) shall be given against problems likely to be encountered, as e.g. heat stress, depending on the air flow rate, work load, environmental atmosphere etc.

I

Page 11 EN 1073-1:1998 Annex A (normative)

Activity sequence for the testing of the protection factor Table A1: Activity sequence for the testing of the protection factor Time of No Activity sequence for the testing activities min 1 dress person in the suit 2 don boots, gloves etc. as required according to the manufacturers instructions 3 person to enter test chamber, connect tubing to the sample point - 3 no test agent establish background reading at sample point with person standing 3 still - no test agent 5 start test agent and allow to stabilize 3 6 record leakage and pressure at sample point with the person stan-3 ding still 7 start treadmill 8 walk 3 record leakage and pressure at sample point with the person wal-

'king at about 5 km/h 10 stop treadmill record leakage and pressure at sample point, person moving arms 1I up and down above head height and looking upward, e.g. lifting 3 object (half brick) from desk to shelf level 12 record leakage and pressure at sample point, person doing conti- 3 nuous squats 13 stop test agent and allow to desperse with person inchamber 3 14 disconnect sample tubes and remove person from test chamber and undress subject NOTE: The total trial may vary, all times are approximate and are to stable conditions.

When doing squats, a slow deliberate action is required, say continuously during about 3s.

Analyse results over final 2 min of each exercise period to avoid carry over of result from one exercise to the other.

Record challenge chemical continuously using a separate detector (if possible). Record the pressure inside the suit over the whole time.

Page 12 EN 10731: 1998 Annex ZA (informative)

Clauses of this European Standard addressing essential requirements or other provisions of EU Directives This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association and supports essential requirements of EU Directive 89/686/EEC.

WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.

The following clauses of this standard are likely to support requirements of Directive 89/686/EEC, Annex II:

EU-Directive 89/6861EEC, Annex II clauses of this standard 1 .1 Design principles 4.1, 4.2, 4.3, 5.5.1 to 5.6 1.2 Innocuousness of PPE 4.1, 4.5, 4.14, 5.2 1.3 Comfort and efficiency 4.1, 4.3, 5.2, 5.4, annex A 1.4 Information supplied by the manufacturer clause 7 2.2 PPE 'enclosing' the parts of the body to be protected 4.1.4, 4.5, 4.8, 5.2 2.3. PPE for the face, eyes and respiratory tracts 4.5, 5.2 2.1 2 PPE bearing one or more identification or recognition clause 6 marks directly or indirectly relating to health and safety 3.9.2.1 Protection against external radioactive contamination clause 4, 5, 6, 7 Compliance with the clauses of this standard provides one means of conforming with the specific essential requirements of the Directive concerned and associated EFTA regulations.

Enclosure 1, Attachment 4 Beaver Valley - L-05-056 Davis Besse - Serial Number 3101 Perry - PY-CEI/NRR-2839L Institute for Nuclear Protection and Security EC Type Examination Certificate No. 0073/197/162/01/96/0001 (Delta Protection MTH 2 Suits)

ECEC 96/0001 Page 1/9 INSTITUTE FOR NUCLEAR PROTECTION AND SECURITY Technical Center for Nuclear Equipment Certification In accordance with the directive 89/686/EEC dated December 21 th 1989 comparing the laws of the States Members Legislations relative to the Personal Protective Equipments, and the decrees no 92-765, 766 and 768 dated July 29t 1992 transposing the directive into French Laws.

The organisation here below mentioned (IPSN / CTHEN) whose references are as follows:

- Address: B.P. no 6 - 92265 Fontenay-aux-Roses Cedex (France).

- Empowered by Order of the Ministries of Employment and Agriculture dated December 24h 1996.

- Identified under the no 0073 (published in the EEC Official Publication dated July 23 th 1994).

Assigns the:

To the following Personal Protective Equipment model:

- Designation: Ventilated Protective Suit against Radioactive Contamination pressurised for a single use only.

- Commercial reference: MTH 2 - ref. 841 442 T.

- Manufacturer: DELTA PROTECTION / REDI - 69 210 Saint-Germain-Sur-L'Abresle.

- Certificate applicant: DELTA PROTECTION - Z.A. De Berret-30200 Bagnols-Sur-Ceze.

- Essential Requirements

Reference:

EN 143, pr EN 1073 (nov. 1995), pr EN 943 (august 1995), EN 270, EN 146.

Date : January 10t 1996 G.BRUHL / Chief of CTHEN Nota : According to article R 223-62 of the 'Working Law", the empowered organisation should be informed of any modification made to the material subject of this EEC type examination certificate, as well as of any modification made to the contents of this technical file on which the delivered type certificate was based on (address, manufacturer name, quality insurance certificate extract, ...)

This certificate contains 12 pages no 1/9 to 9/9 Fench vmlo wony 6110b. ud whendi.p"t

ECEC 96/0001 Page 2/9

1. DESCRIPTION It is a Ventilated Protective Suit against Radioactive Contamination ventilated type - pressurised for a single use only, its name is:

MTH2 - ref. DELTA: 841 442 T The T values are defined according to the size of the suit.

The suit includes:

- A air tight suit with an incorporated hood

- A suit fastening system located on the back of the suit.

- A breathable air flow supply system.

- A air exhaust device.

- A safety strip for emergency opening located on the hood.

Front view Profil Hood Ocular

,, 7a K Dosimetric window li l t

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f ECEC 96/0001 Page 3/9 1.1. MAIN MATERIALS

- Skin of the suit:

White polyethylene: Ethyfuge 2000 Thickness: 24/100 mm

- Hood:

PE Cristal - 30/100 mm thickness.

- Visor:

PVC (astraglass) 50/100 mm thickness.

- Gloves:

PVC Sempersoft type - Size 9-91/2, and Semperstar type - size 10-10 Y2..

- Boots:

Polyethylene - 24/100 mm thickness, reinforced with PE cristal.

1.2. COMPONENTS

- Internal Ventilation System:

It includes a total ventilation V4 fitted with a valve with CEJN (ref:342) butt.

- Exhaust:

It includes two exhaust valves located on the head and on the back of the suit.

- Fastening device:

It includes a double zip fastener located vertically on the back of the suit.

- Other components:

The suit includes:

- A safety strip for an emergency opening located on the hood.

- A acoustic link tunnel.

- A loop for breathable air supply pipe.

- Several internal strengthening pieces for elbows, knees and legs.

- A transparent window to visualise the dosimeter.

2. CONFORMITY TO REQUIREMENTS 2.1. REQUIREMENTS FOR THE MATERIALS (except accessories: Gloves, slippers...)

(See paragraph 5.1. of the prEN 1073)

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so ECEC 96 10001 Page 4/9 2.1.1. Abrasion Resistance Test according to the Norm EN 530 - method 2 (abrasive paper 00). The classification is carried out according to the following diagram:

Class Number of cycles 6 > 2 000 cycles 5 > 1500 cycles 4 > 1 000 cycles 3 > 500 cycles 2 > 100 cycles 1 > 10 cycles Results: Class 6 for Ethyfuge 2000 - 24/100 mm thickness.

Class 6 for PVC.

.1.2. Flex cracking Resistance Test according to the Norm ISO 7854 - method B. The classification is carried out according to the following diagram:

Class Number of cycles 6 > 100 000 cycles 5 > 40 000 cycles 4 > 15 000 cycles 3 > 5 000 cycles 2 1 > 2 500 cycles 1 > 1 000 cycles This test is not applicable to suits for one single use only.

2.1.3. Puncture Resistance Test according to the Norm EN 863. The classification is carried out according to the following diagram:

Class Puncture resistance 3 >I100 N 2 > 50N 1 > 1ON Results: Class 1 for Ethyfuge 2000 - 24/100 mm thickness.

Class 2 for PE cristal.

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ECEC 96/0001 Page 5/9 2.1.4. Resistance In blocking Test according to the Norm ISO 5978. The classification is carried out according to the following diagram:

Class - Comments 2 non stick 1 sticky This test is not applicable to non-coated materials.

2.1.5. Tear Resistance Test according to the Norm ISO 9073-4. The classification is according to the following diagram:

Class Applied strength 6 > 150 N 5 > 80N 4 > 40N 3 > 20N 2 > 1ON 1 > 2N Results :. Class 4 for Ethyfuge 2000 - 24/100 mm thickness.

Class 3 for PE Cristal.

2.1.6.Flammability of materials, visors, and ancillary parts Tests are carried out according to the Norms EN 1146 - single burner test (paragraph 7.5.3).

Results: Test requirements entirely fulfilled.

2.2. REQUIREMENTS FOR THE ACCESSORIES 2.2.1 Gloves The gloves set on the MTH2 ref. 841 442 T comply with the specific requirements for this type of Individual Protection Equipment, mainly to the Norm EN 421 Protective Gloves against ionizer radiation and radioactive contamination".

They have Special EC Examination Certificates (ECEC) based on contracted tests.

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ECEC 96/0001 Page 6/9 2.2.2.Boots The boots are part and parcel of the suit and are made of the same constituted material.

Consequently they comply with the requirements.

2.3. REQUIREMENTS FOR THE PROTECTIVE SUIT 2.3.1. Suit Design: Practical Performance Test The Practical Performance Test is carried out according to the prEN 1073 (paragraph 6.2.).

The conditioning is according to the manufacturer directions for use.

Parameters Valuations a) Harness comfort Aimless b) Security of fastenings & couplings Good c) Accessibility of adjusting devices Good d) Clarity of vision through visor Good e) Suit comfort Good g) Other parameters No particular notice 2.3.2. Fit Factor (paragraph 5.2.2. of the pr EN 1073)

The protection factor is determined according to the PrEN 944 standard (paragraph 8.9) by respecting the sequences indicated in Annex A of the PrEN 1073.

The mean leakage value ( or inversely, the protection factor) enables a clothing classification according to the following table. The preconditioning according to the instructions for use recommendations.

Maximum accepted values, in %,of the ratio of the Ventilated average Inward Leakage inside the hood, pressurised calculated on the whole lot of suits FIT FACTOR Suit classification For One activity For all activities 5 0.004 0.002 50 000 4 0.010 0.005 20 000 3 0.020 0.010 10 000 2 0.040 0.020 5 000 1 0.100 0.050 2 000 Results: The suit is classified 5.

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ECEC 96/0001 Page 7/9 2.3.3.1. Seams, Joins and Assemblages pull test resistance 2.3.3.1. Seams i Welds (paragraph 5.2.3.1 of the pr EN 1073)

A sample of each type of seam/weld is tested according to the Norm ISO 5082 (annex 2).

The seam performance level is according to the following classification:

Class Seam resistance (N) 5 > 300 4 > 125 3 > 75 2 > 50 1 > 30 The tests have been applied to the following welds:

- Elbow and knee reinforcement

- Crotch assembly

- Belt assembly

- Booties assembly Results: All the welds are classified 3.

2.3.3.2. Joins and Assemblages (paragraph 5.2.3.2. - prEN 1073)

This suit has no removable parts. This paragraph is aimless.

2.3.4 Gas tight (paragraph 5.2.4. of prEN 1073.

The test was carried out according to the EN 464 standard . The loss of pressure shall not be greater than 4 mbar in 6 minutes.

Results : Test not undertaken as the clothing is not considered as an gastight suit.

2.3.5. Visors (paragraph 5.2.5. of prEN 1073)

The distortion of vision is measured, during the Practical Performance. The mechanical resistance test of the visor is according to the Norm EN 146 (paragraph 6.6 and 6.7.).

Results: Distortion of vision: Up to requirement.

Mechanical resistance : up to requirement.

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ECEC 96/0001 Page 8/9 2.3.6. Air supply system (paragraph 5.2.6. of the pr EN 1073)

The couplings and connections must comply with the requirements of the paragraphs 6.7.1.,

6.7.2., and 6.11.7. of the EN 270. The connection between the compressed air supply system and the suit mutt resist to a 250 N pull.

Result: requirement entirely fulfilled.

2.3.6. Breathing Hose (paragraph 5.2.7. of the pr EN 1073)

Tests are performed according to the EN 270 (paragraph 7.2. and 7.6). The pipes must not block the movements nor cause a rupture of the air supply during the Practical Performance Test.

Result: No constraint.

2.3.7. Air supply flow rate (paragraph 5.2.8. of the PrEN 1073)

The test is carried out according to the PrEN 1073 standard (paragraph 6.3).

Result:

Minimal flow rate:30 m3 .h 1 (500 I/min 1) for a 6 Bar supply pressure Maximal flow rate:66 m3 .h 1 (1100 I/min11 ) for a 5.5 Bar supply pressure 2.3.8. Air flow rate warning device (paragraph 5.2.9. of the pr EN 1073)

If a warning is fitted, it must comply to the EN 270 (paragraph 6.13.3). The test must be carried out according to the EN 270 (paragraph 7.12). The sound level must be higher than 85 dB(A).

Result: Aimless (there is no sonic warning device).

2.3.9. Air supply valve (paragraph 5.2.10 of the pr EN 1073)

Where present, the control valve should enable a variation of flow rate between the minimum and maximum specified values without the possibility of closure.

Result: Requirements entirely fulfilled.

2.3.11.Exhaust devices (paragraph 5.2.11. of the pr EN 1073)

The exhaust devices must work correctly after the testing of the pressure in the suit, during the Practical Performance Test and during the determination of the Fit Factor. Test in accordance with the EN 1073 (paragraph 6.6.).

Results: Good valves working.

Pull resistance superior to the fixed limit.

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ECEC 96/0001 Page 9/9 2.3.12.Pressure in the suit During the activity sequence as specified, the overpressure shall not exceed 1000 Pa mean and 2000 Pa peak. A positive pressure shall be maintained.

Result: Requirements entirely fulfilled.

2.3.13.Carbon dioxide content of the inhalation air The CO2 content of the inhalation air, determined at the minimum air flow rate, shall not exceed an average of 1% (by volume), tested according to the EN 270 (paragraph 7.15).

Result: Requirement entirely fulfilled.

2.3.14. Noise associated with the air supply to the suit (paragraph 5.2.14 - pr EN 1073)

Test according to the EN 270 (paragraph 7.16). The noise measured in the suit at the ears shall not exceed 80 dB(A) at the maximum air flow rate as indicated by the manufacturer.

Result: Requirement entirely fulfilled.

3. CHECKINGS 3.1. MARKING (paragraph 7 of the pr EN 1073)

The marking is satisfies the requirements of article 7 in the EN 340.

3.2. MANUFACTURER INFORMATION (Paragraph 8 of the pr 1073)

The manufacturers information complies with the specifications in paragraph 8 of the EN 340.

They contain the instructions for use, the usage conditions and the specific limits and restraints.

3.3. MAINTENANCE MARKING This is aimless, the suit being for one single use only.

4. CONCLUSIONS Upon presentation of the tests results, the Ventilated suit - pressurised for a single use only, MTH 2 - ref. 841 442 T is certified to ensure a protection against radioactive contamination according the following specified limits:

- Minimum air flow rate: 30 m3.h-1 (500 I.mina')

- Maximum air flow rate: 66 m3.h".(1100 l.mina)

Fmnchw.nIn ory WWIbe used whn di.p"te

Enclosure 1, Attachment 5 Beaver Valley - L-05-056 Davis Besse - Serial Number 3101 Perry - PY-CEI/NRR-2839L Test Results Carried Out on the Full Encapsulated Suit MTH 2 ref. 841442T For the EC Type Examination Certificate No. 0073/197/162/01/96/0001.

DPEA/STESRICTHEN/02-642 Page 1/2 Test Results carried out on the full encapsulated suit MTH2 ref. 841442T For the EC Type Examination Certificate N0 0073/1 97/162/01/96/0001 You will find below the detailed results taken in account for being able to statue on the conformity of this equipment in accordance with the Essential Requirements of the European Standard pr EN 1073-1 (revision Nov 1995). Other results those are non pointed out inthis report are alreadywritten in the EC TYPE Examination certificate (dated December 10t 1997) 1 - Air Flow entering the suit when connected to a 6 bar feeding pressure (paragraph

.5.2.8. of the EC Type Examination Certificate)

Suit Entrance valve position Air flow feeding pressure air flow (m3Ih 1 number Bar / psig I/mn/ cfm) 1 Fully open 5,5/ 77 66/1100/ 38 1 Closed 6,0/ 87 30 / 500 / 17 2 Fully open 5,5/ 77 65 /1080 /37,8 2 closed 6,0/ 87 31 / 516 / 18 2 - Carbon dioxide content of the Inhalation air when measured at the minimum air flow (Daracraph 5.2.13. of the EC Examination Tvpe)

Suit Feeding pressure Air flow C02 contents(%)

number Bar / psig MIh3/h / cfm 1 6/87 30/ 17 0,85 2 6/87. 31 / 18 0,80 3 - Noise level associated with the air supply to the suit when tested at the maximum air flow rate (paragraph 5.2.14 of the EC Examination Type)

Suit Feeding pressure Air flow Noise level (dB) number -Bar Ipsig M3/h; cfm 1 5,5/ 77 66/38 76,8 2 5,5/ 77 65/37,8 78,5

Page2/2 4 - Inward leakage average- Fit Factor measured at the minimal air flow of 4501/mn (paragraph 2.3.3. of the CE Examination Tvpe)

Suit n' 1 2 Exercise Air flow m3/h Il/mn / cfm 30 / 500 / 17 31 /516/ 18

>Standing still 130 000 130 000 Walking ( 5 km/h) 59 500 50 000 Moving arms up and down 125 000 125 000 above head Continuous squats 65000 81 250 Bending forward 100 000 92 850 Person twisting at waist 115 000 130 000 Standing still 130 000 130 000 Average 103 500 103 440 5 - Pressure In the suit when measured at the maximum air flow when suit connected under 5.5 bar (77psiq) feeding pressure (paragraph 4.12.of the EC Examination Tvpe)

Suit n°1 2 Exercise P ave/ P min/ Pmax P ave; P min, P Max.

daPa. daPa Standing still 40 - - 38 - -

Walking (5 km/h) 40 23 74 100 61 128 Moving arms up and down 40 17 62 46 18 72 above head Continuous squats 42 4 86 56 3 110 Bending forward 52 3 104 74 0 162 Person twisting at waist 38 18 58 46 20 110 Person crawling 37 - - 40 -

For Information: Both overboots are breaked at the end of the test 6 Over pressure and fit factor when person crawling on the floof as indicated in paragraph 4.12 and 5.2.2 of the Pr EN 1073-1 dated 1995 Suit number Crawling exercise Average DP Minimum DP Maximum DP Fit Factor i daPa daPa daPa 1 52 12 90 110 000 2 65 3 102 105 000 7 Screen:( paragraph 5.2.51I

- Distortion of the vision: none

- Mechanical resistance: no incidence on the screen.

Enclosure 1, Attachment 6 Beaver Valley - L-05-056 Davis Besse - Serial Number 3101 Perry - PY-CEI/NRR-2839L MTH 2 Instructions For Use

I. ., NO/841442T INDICE: e M UT.H 32 DATE: 12/00 PAGE: 1/1 INSTRUCTIONS FOR USE Preliminary remarks: This clothing Is to be used under the authority of the person responsible for the intervention who has previously checked that:

- the clothing offers the necessary protection for the risk category to be encountered during the intervention.

- Breathable air

  • sockets, with connectors compatible with that of the clothing, are actually available on the intervention site and that they are capable of supplying a sufficient quantity of air:

minimum flow rate 500 liters/min. +1 0% at 6 Bars; (17 cfm at 87 psig) maximum flow rate 1100 liters/min. +I- 10% at 6 Bars; (38cfm at 87 psig)

DRESSING

- The wearer, with a helper, visually inspects the state of the garment and Its components then removes the shipping protection (cardboard on the visor and Inside the garment, and removable Ocristal' on the visor).

- He slips on the bottom of the garment through the rear opening.

  • Connects to the breathable air circuit by passing the supply pipe through the loop at the rear of the garment, at the same height as the supply valve.

- Connects, if used, the MURUPHONE system and finishes dressing.

- The helper zips up the dual zipper system and applies a large strip of adhesive tape to the upper extremity of the second zip to ensure air tighness; he ties the over boot laces around the ankles.

- The wearer controls the correct functioning of the air supply; the correct functioning of the supply flow valve and the over pressure valves by crouching rapidly a few times.

- He can go to the work zone.

UNDRESSING

- Removal may be done with the strap envisaged for this usage in the following manner; while the garment is still being supplied with air, the helper pulls on the orange strap, which runs from one wrist to the other over the helmet, and rolls up the front and rear parts in a way that traps the contamination and avoids all contact with the Intervening person.

IMPORTANT

- Leave the work zone Immediately if the clothing deflates during the intervention, if the helmet fogs or If the person has a feeling of excessive warmth.

- Remenber that the clothing remains pressurised for a few moments in the case of an air supply failure STORAGE In the original packaging; out of the light; between + 50C and + 450C.(41 OF and 11 30F)

USAGE The air supply should be between + 150C and + 450C. ( 59'F and 11 3 0F)

EXPIRY DATE The clothing should be used by the third year from the date of manufacture.

CLEANING Not necessary for this type of equipment which is for a simple usage only.

EMERGENCY MEASURES

- Air outside of the garment can be breathed by removing the strap at the front of the helmet.

- The removal strap, removed by the wearer, enables the wearer to get out of the garment in under 5 seconds.

  • Breathable air: see the EN 132 standard.

40 i-Enclosure 2 Beaver Valley - L-05-056 Davis Besse - Serial Number 3101 Perry - PY-CEI/NRR-2839L Page 1of 1 Regulatory Commitments The following table identifies the actions that are considered to be regulatory commitments. Any other actions discussed in this document represent intended or planned actions, are described for the NRC's information, and are not regulatory commitments. Please notify Mr. Gregory A. Dunn, FirstEnergy Nuclear Operating Company, Fleet Licensing Manager, at (330) 315-7243 of any questions regarding this document or any associated regulatory commitments.

Commitments

1. The Delta Protection Supplied-Air Containment Mururoa V4 MTH2 Suits will be integrated into the First Energy Nuclear Operating Company (FENOC) respiratory program using the manufacturers recommendations.
2. FENOC lesson plans will be developed to train workers on the Delta Protection Supplied-Air Containment Mururoa V4 MTH2 Suit features, donning, use and removal, and use of mouth strip and tear off strips for routine and emergency egress.
3. FENOC radiation protection personnel will be provided additional training for selection, approval, issue, equipment set-up, operation and maintenance instructions for the Delta Protection Supplied-Air Containment Mururoa V4 MTH2 Suits.
4. The Delta Protection Supplied-Air Containment Mururoa V4 MTH2 Suits will be be discarded after a single use.
5. Any defects identified in a Delta Protection Supplied-Air Containment Mururoa V4 MTH2 Suit will be entered into the FENOC Corrective Action Program and reported to the manufacturer.