Document: NRC Regulatory Guide
Document ID: 65325e1a-3033-4f91-a5fa-fcd1286b72ec
Document Type: regulatory_guide
Title: Dedication of Commercial-Grade Digital I&C Items for Use in Nuclear power Plants
Source: NRC Regulatory Guide Division 1
Source URL: https://www.nrc.gov/docs/ML2200/ML22003A180.pdf
Revision Date: 2023-05
Chapter: 
Section ID: RG-1.250
CFR Part: 
CFR Title: 

Content:
08. The dedicating entity verifies the dependability critical characteristics, i.e., that the equipment is manufactured to the appropriate SIL through inspections, tests, or analyses supplemented by a commercial grade survey. Under NEI 17-06, the commercial grade survey takes the form of certification under IEC 61508 (which uses ISO/IEC 17065, “Conformity assessment — Requirements for bodies certifying products, processes and services,” (Ref 11) for the certification process) by an accredited certifying body. The dedicating entity, in accordance with NEI 17-06, dedicates the certification as a commercial grade service provided DG-1402, Page 7 by the certifying body. Verification of acceptability of the certifying body’s commercial grade surveys is supplemented by the dedicating entity’s own commercial grade survey, either through observation of the accreditation of the certifying body or observation of a certification using the checklist provided in NEI 17-06, Appendix D. Thus, a dedicating entity need only dedicate the services of the certifying body on a periodic basis. The NRC staff has reviewed IEC 61508, 2.0 Edition and ISO/IEC 17065:2012 for this purpose and observed the accreditation of exida.com LLC by ANAB in 2021. The NRC staff’s review and observation show that IEC 61508 process has many parallels to the requirements of 10 CFR Part 50, Appendix B and indicate that SIL certification by exida.com LLC or other ANAB accredited certifying bodies is a reliable method for verifying acceptability of the dependability critical characteristics of electronic and programmable electronic equipment, if dedicated in conformance with the staff positions described in section C below. Consideration of International Standards The International Atomic Energy Agency (IAEA) works with member states and other partners to promote the safe, secure, and peaceful use of nuclear technologies. The IAEA develops Safety Requirements and Safety Guides for protecting people