ML20137Q526
| ML20137Q526 | |
| Person / Time | |
|---|---|
| Issue date: | 11/12/1981 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20136D915 | List:
|
| References | |
| FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8509230030 | |
| Download: ML20137Q526 (12) | |
Text
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[gg/ /aj/ gM va/h .mtw_7 NOV 121981 poiz D. /
,, Part 35--Medical use of Byproduct liaterial
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5.1 Purpose and Scope
. 35.1. also refer to P19, 20, 21, 30.
35.2 Conformance requirement. 35.2 35.3 Definitions
- a medical use means the use of BPM for the diagnostic, prognostic, or therapeutic benefit of a human being or animal b human b human use means the internal or external administration of BPft, or the radiation therefrom, to human beings, c physician means. . . 35.3a d supervision means. . .
CM G 3 e in vitro medical use means the use of BPfi for the diagnostic or prognostic benefit of a human being or animal. It does not include human use or animal use.
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'j-f therapy misadministration means. . . 35.41 except d g animal use means the internal or external administration of BPM, or t,he radiation thcrefrom, to animals.
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l'AP @ J h person means. . . 20.3a7 and 11 i individual means. . .
35.4 Application forms 35.4 35.5 ALARA cornitment RG10.8Pl.4, RG3.18, RG8.10, NUREG-0267, TP608-4 35.6 Training per 19.12 and 19.13 35.7 a Facility shall be adequate and maintained 30.33 b Equipment shall be adequate, maintianed, and calibrated per requirements herein 30.33 35.8 terms and conditions 30.34 except g 35.9 license expiration 33.36 (o - 35.10 renewal 30.37 35.11 amendments 30.38 fjj92g030050906 35 50FR30616 PDR
NOV 12 MR1 35.12 Commission action on applications 30.39 O 35.13 transfer of BPt1 30 ~. 41 35.14 records requirements and format 30.51 35.15 right to inspect 30.52 35.16 right to check facility and equipment 30.53 35.17 right to nodify licenses 30.61 35.18 right to recall material 30.62 35.19 violations 30.63. add fine structure.
35.20 unless soecifically exempted herein, see also P19, 20, 21, 30 35.21 sealed source checks a leak test 35.14e b inventory 35.14f 35.22 records of receipt 30.51 35.23 records of transfer and disposal 30.51 35.24 dose calibrator nethod of calibration RG10.8AppD2 35.25 Survey meter calibration RG10.8AppD1, TP608-4p8 35.26 LSC, SCA calibration no known references 35.27 Package receipt procedures 10CFR20.205, RG10.8p8 l
35.28 Right of visiting physicians SLC23, SLC62 35.29 Decay in Storage method NMSS letter 35.30 decontrol of LSCW 20.306 35.31 sewer disposal 20.303 35.32 patient excreta 20.303d 30.33 see 170 for fees i
30.34 personnel monitoring per part 20 30.35 records retention period two years unless otherwise noted.
30.36 right to request exemption 34.51
NOV 121981 Requirements for Group E users exempt and registration O k4ts. 35.31ei-5. 31.ilei-7 35.50 Eligibili ty, any person may apply for a group E license 35.51 Authorized suppliers, manufacturer per 32.70 or 32.71, 35.22 herein.
35.52 Authorized use. only per package insert. 35.lldl-7 only for human use or in vitro medical use. flot for animal use.
35.53 Inventory. store in original container. 35.31cl,2, 31.llal-7, 31. llc 1 35.54 transfer and disposal a another Group E licensee if in original container b licensed rad waste company c sewer 20.333 d house waste 35.31c5. exenpt the mock e decay in storage source.
f obliterate all radiation labels g in such manner as to not be incorporated in food for humans or animals O 35.55 all use described above is exempted from consider release from receipt, training and record keeping requirements transfer, disposal records.
in this part.
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NOV 121981
,o Requirements for Group I users 35.100 I (uptake, dilution, b) excretion) 35.100 Eligibility. any physician, management if in a hospital or clinic.
35.101 Authorized suppliers. manufacturer per 32.72 or 32.73, 35.22 herein.
35.102 Authorized use. per package insert.
only for human use. not for animal use.
if not for indications on package insert,
, nevertheless shall comply re form, dose, range. 35.14b6 35.103 Inventory. as needed. also, calibration NRC313:1, 35.14d.
and reference sources.
35.104 Transfer and disposal.
a another Group I licensee if in original container b licensed rad waste company c sewer d decay in storage e obliterate all radiation labels
(s) f in such manner as to not be incorporated in food for humans or animals.
NOV 121981 g Requirements for Group II users 35.100 II (imaging, unit Q doses only) 35.200 Eligibility. any physician, management if in a hospital or clinic.
35.201 Authorized suppliers. manufacturer per 32.72 or 32.73. 35.22 herein.
35.202 Authorized use. per package insert.
- only for human use. not for animal use.
if not for indications on package insert, nevertheless shall comply with form, dose, range. 35.14b6 35.203 Inventory. as needed. also, calibration flRC313fi, 35.14d and ieference sources.
35.204 Transfer and disposal, a another Group II licensee if in original container b licensed rad waste company c sewer d decay in storage e obliterate all radiation labels O
U' f in such manner as to not be incorporated in food for humans or animals, 35.205 ? xenon and particulates?
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NOV 1219D Requirements for Group III users 35.100 III (imaging,
() generators) 35.300 Eligibility. any physician, management ? training and experience?
if in a hospital or clinic.
35.301 Authorized suppliers. manufacturer per 32.73. 35.22 herein. cold kits only from authorized supplier. 35.14b2 35.302 Authorized use, per package insert. >
only for human use, not for animal use.
if not for indications on package insert, nevertheless shall comply with form, dose, range. 35.14b6 35.303 Inventory. specify total activity of eachNRC313M parent type, including both active generator and generators in storage, also calibration and reference sources. 35.14d 35.304 Transfer and disposal, a another Group III licensee if in original applies to both cold kits container and generators b licensed rad waste company O
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c sewer d decay in storage e obliterate all radiation labels f in such manner as to not be incorporated in food for humans or animals.
30.305 ? xenon and particulates?
..0 2 34f %)
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NOV 121981 Requirements for Group IV users 35.100 IV (therapy below O'
s.s 30 mci) 35.400 Eligibility, any physician, management ? training and experience?
if in a hospital or clinic.
35.401 Authorized suppliers. manufacturer per 32.72, 35.22 herein 35.402 Authorized use. per package insert.
only for human use. not for animal use, 35.403 Inventory, as needed. also, calibration NRC313M and reference sources. 35.14d 35.404 Transfer and disposal a another group IV licensee if ir. original container b licensed rad waste company c sewer d decay in storage e obliterate all radiation labels f in such manner as to not be in corporated in food for humans or animals.
35.405 ? fume hood for iodine? RG8.23Pl.14 35.406 misadministration 35.42, 35.44, 35.45.
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NOV 121991 Requirements for Group V users 35.100 V (therapy above Group IV) 35.500 Eligibility. any physician and hospital ? training and experience?
management.
35.501 Authorized suppliers. manufacturer per 32.72, 35.22 herein.
35.502 Authorized use. per package insert, only for human use, not for animal use.
35.503 Inventory. as needed, also calibration NRC 313N and reference sources. 35.14d 35.504 Transfer and disposal a another group V licensee if in original container b licensed rad waste company c sewer d decay in storage e obliterate all radiation labels f in such manner as to not be incorporated in food for humans or animals.
35.505 fune hood for iodine storage, double
]\ containment. RG8.23Pl.14 35.506 misadministration 35.42, 35.44, 35.45 35.507 release patient only when less than 30 mci residual activity SLC53 O
1 NOV 121981 Requirements for Group VI users new group. diagnostic y devices contained in 35.100 VI 35.600 Eligibility, any physician, management training required at if in a hospital or clinic. 35.13b 35.601 Authorized suppliers, manufacturer per 32.74, 35,22 herein.
35.602 Authorized use. per package insert.
35.603 Inventory. Specify total activity for
, each type of use desired. Include both active and replacement source in storage. also calibration and reference sources. 35.14d 35.604 Transfer a'n d disposal, a another group VI licensee authorized for the specific device and source therein, b licensed rad waste company c supplier d transfer to NRC or agreement state 35.605 note sealed source requirements at leak test and inventory 35,si herein, 35.606 equipment shall be adequate and n'aintained and source shall be replaced per instructions of supplier,
NOV 121981 f Requirements for Group VII users new group, therapy sealed (m) sources in 35.100 VI 35.700 Eligibility. any hospital and physician training required at 35.13b 35.701 Authorized suppliers. nanufacturer per 32.74, 35.22 herein, 35.702 Authorized use, only as specified in group VII. Only for human use. not for animal use,
, 35.703 Inventory. Specify total activity and supplier for each type of use listed in group VII, also calibration and reference sources. 35.14d 35.704 Transfer and Disposal.
a another group VII licensee authorized for the specific source, b licensed rat: waste company c supplier d transfer to ifRC or agreement state 35.705 note sealed source requirements at
- 35. ,2 /. _ herein. les, test and inventory v 35.706 survey patient, room, and count seeds and compare to number implanted befcre releasing patient. 35.14b5vii 35.707 Misadministration 35.42, 35.44, 35.45 (v^'\
NOV I P.1981 n Requirements for Group VIIIusers new group, teletherapy.
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35.800 Eligibility. Any physician. also training required at management if in a hospital or clinic 35.13b. List all users per TP608-4p22-24 35.801 Authorized suppliers, manufacturer per part 30, or 35.22 herein.
35.802 Authorized use. Only as specified in add research, training, materials.
group VIII. Does not authorized working 0339pl3PE, PIV. SLC198.
on the unit, or relocation. TP608-4 35.803. Inventory. Specify total activity for 0339p6 each source, cnd RH!i. also calibration 35.14d and reference sources, also U for shielding. SLC21 35.804 Site specific infomation.
a drawings, plans, elevations TP608-4p10,ll; 0339p6C,10D3 b shielding TP608-4p12, 35-37 c interlocks SLC17, 18 35.805 Machine specific infomation and survey 0339pl7, TP608-4pil 35.806 Equipment (O
J a Two calibrated survey meters, one on hand at all times.
b area monitor SLC24 c dosimetry system d spot check system e leak test system f viewing system 35.807 Post nomal operating and emergency 0339p12, 608-4pl3 procedures 35.808 Full calibration a when 35.21a b what is to be calibrated 35.21b c how the calibration is to be done 35.21c,d d instrumentation 35.23 e who may do 35.21e, 35.24 35.809 Spot checks a when 35.22a b what is to be checked 35.22b c instrumentation 35.23b d how the check is to be done 35.22c e who may do 35.22c Ov
NOV 121981 Requirements for Group VIII users continued 35.810 Head survey procedure TP608-4,p38,p45 35.811 Environs survey, interlocks, et alia TP608-4p40, SLC19 35.812 Misadministration 35.42, 35.44, 35.45 35.813 Five year service and maintenance SLC20, 0339pl9B
. 35.814 Isotope committee TP608-4p38,p45 O
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