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:
rocess, the certifying bodies will provide a certificate of compliance to IEC 61508 criteria and document the results of their analysis in the form of a certification report. The product safety manual describes the conditions of use under which the product has been found to meet the predicted failure rate and that must be maintained by the user to ensure the device will continue to comply with the failure rate provisions of the IEC 61508 standard. To be established as a credible entity, the certifying body is accredited by the national accrediting body. The accrediting body ensures that a certifying body is competent to perform the necessary evaluations of the manufacturers’ products. In the United States, the currently recognized accrediting body is the American National Standards Institute National Accrediting Board (ANAB). Accrediting bodies around the world are linked under the International Accreditation Forum Multilateral Recognition Arrangement. Since early 2016, external nuclear power industry stakeholders have engaged the NRC staff about SIL certification, the certification process, and the accreditation process. From this engagement, the NEI produced NEI 17-06, which provides guidance for the use of an accredited SIL certification to IEC 61508 within a digital I&C item’s dedication for its critical characteristics of dependability. This topic has been part of related agency activities to modernize the NRC regulatory infrastructure to enable the expanded safe use of digital I&C (Ref 10). Thus, under NEI 17-06, the critical characteristic of dependability described in TR-106439 for commercial grade dedication of electronic and programmable electronic equipment is met if the equipment is manufactured to an appropriate SIL level in conformance with IEC 61508. 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