10 CFR 71.107, Package Design Control

Package design control

a

(a) The licensee, certificate holder, and applicant for a CoC shall establish measures to assure that applicable regulatory requirements and the package design, as specified in the license or CoC for those materials and components to which this section applies, are correctly translated into specifications, drawings, procedures, and instructions. These measures must include provisions to assure that appropriate quality standards are specified and included in design documents and that deviations from standards are controlled. Measures must be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the functions of the materials, parts, and components of the packaging that are important to safety.

b

(b) The licensee, certificate holder, and applicant for a CoC shall establish measures for the identification and control of design interfaces and for coordination among participating design organizations. These measures must include the establishment of written procedures, among participating design organizations, for the review, approval, release, distribution, and revision of documents involving design interfaces. The design control measures must provide for verifying or checking the adequacy of design, by methods such as design reviews, alternate or simplified calculational methods, or by a suitable testing program. For the verifying or checking process, the licensee shall designate individuals or groups other than those who were responsible for the original design, but who may be from the same organization. Where a test program is used to verify the adequacy of a specific design feature in lieu of other verifying or checking processes, the licensee, certificate holder, and applicant for a CoC shall include suitable qualification testing of a prototype or sample unit under the most adverse design conditions. The licensee, certificate holder, and applicant for a CoC shall apply design control measures to the following:

(1) Criticality physics, radiation shielding, stress, thermal, hydraulic, and accident analyses;

(2) Compatibility of materials;

(3) Accessibility for inservice inspection, maintenance, and repair;

(4) Features to facilitate decontamination; and

(5) Delineation of acceptance criteria for inspections and tests.

c

(c) The licensee, certificate holder, and applicant for a CoC shall subject design changes, including field changes, to design control measures commensurate with those applied to the original design. Changes in the conditions specified in the CoC require prior NRC approval.

External Links

[[URL::http://www.nrc.gov/reading-rm/doc-collections/cfr/part071/part071-0107.html%7CNRC website 10 CFR 71.107]]

v t e Code of Federal Regulations
Title 10 Part 71 - PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL
10 CFR: 1 2 4 5 7 9 10 11 12 13 14 15 16 19 20 21 25 26 30 31 32 33 34 35 36 37 39 40 50 51 52 54 55 60 61 62 63 70 71 72 73 74 75 76 81 95 100 140 150 160 170 171
0, General Provisions, Purpose and scope 1, Communications and records 2, Interpretations 3, Requirement for license 4, Definitions 5, Transportation of licensed material 6, Information collection requirements: OMB approval 7, Completeness and accuracy of information 8, Deliberate misconduct 9, Employee protection 10, Public inspection of application 11, Protection of Safeguards Information 12, Exemptions, Specific exemptions 13, Exemption of physicians 14, Exemption for low-level materials 15, Exemption from classification as fissile material 16, 17, General Licenses, General license: NRC-approved package 18, 19, Previously approved package 21, General license: Use of foreign approved package 22, General license: Fissile material 23, General license: Plutonium-beryllium special form material 24, 25, 31, Application for Package Approval, Contents of application 33, Package description 35, Package evaluation 37, Quality assurance 38, Renewal of a certificate of compliance or quality assurance program approval 39, Requirement for additional information 41, Package Approval Standards, Demonstration of compliance 43, General standards for all packages 45, Lifting and tie-down standards for all packages 47, External radiation standards for all packages 51, Additional requirements for Type B packages 53, 55, General requirements for fissile material packages 57, 59, Standards for arrays of fissile material packages 61, Special requirements for Type B packages containing more than 105A2 63, Special requirement for plutonium shipments 64, Special requirements for plutonium air shipments 65, Additional requirements 71, Package, Special Form, and LSA-III Tests^{<a href="#N_2_7171">2</a>}, Normal conditions of transport 73, Hypothetical accident conditions 74, Accident conditions for air transport of plutonium 75, Qualification of special form radioactive material 77, Qualification of LSA-III Material 81, Operating Controls and Procedures, Applicability of operating controls and procedures 83, Assumptions as to unknown properties 85, Preliminary determinations 87, Routine determinations 88, Air transport of plutonium 89, Opening instructions 91, Records 93, Inspection and tests 95, Reports 97, Advance notification of shipment of irradiated reactor fuel and nuclear waste 99, Violations 100, Criminal penalties 101, Quality Assurance, Quality assurance requirements 103, Quality assurance organization 105, Quality assurance program 107, Package design control 109, Procurement document control 111, Instructions, procedures, and drawings 113, Document control 115, Control of purchased material, equipment, and services 117, Identification and control of materials, parts, and components 119, Control of special processes 121, Internal inspection 123, Test control 125, Control of measuring and test equipment 127, Handling, storage, and shipping control 129, Inspection, test, and operating status 131, Nonconforming materials, parts, or components 133, Corrective action 135, Quality assurance records 137, Audits Appendices: 10 CFR 71 Appendix A

10 CFR 71.107, Package Design Control

a

b

c

External Links

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