Document: NUREG-0800
Document ID: b9d43224-eb4e-4b19-a212-b3bb8c0ffbb5
Document Type: srp
Title: Diversity and
Source: NUREG-0800
Source URL: https://www.nrc.gov/docs/ML0706/ML070660258.pdf
Revision Date: 2023-06
Chapter: 7
Section ID: 7.9
CFR Part: 
CFR Title: 

Content:
riteria from which the inspection activities for a specific product may be derived. For operating license, operating license amendment, or combined license applications, the product inspections should also confirm that the reviewed systems are installed, operated, and maintained appropriately. NRC Inspection Manual, Chapter 52001, "Digital Retrofits Receiving Prior Approval," provides guidance for inspecting these activities. H. Review of the Acceptance of Commercial-Grade Digital Equipment All software, including operating systems, that is resident on safety system computers at run time must be qualified for the intended applications. Qualification may be established either by producing the PDS items under a 10 CFR Appendix B quality assurance program or by dedicating the item for use in the safety system as defined in 10 CFR 21. Review topics for the former are described above. Review for the latter requires a determination that a suitable acceptance process has demonstrated reasonable assurance that the equipment will perform its intended safety function. Appendix 7.0-A-15 Revision 5 - March 2007 10 CFR 21 states that "this assurance is achieved by identifying the critical characteristics of the item and verifying their acceptability by inspections, tests, or analyses performed by the purchaser or third-party dedicating entity after delivery, supplemented as necessary by one or more of the following: commercial grade surveys; product inspections or witness at holdpoints at the manufacturer's facility, and analysis of historical records for acceptable performance." An acceptable set of fundamental requirements for this process is described in IEEE Std. 7-4.3.2-2003, Clause 5.4.2, as endorsed by Regulatory Guide 1.152, Revision 2. In this guidance, the qualification process is accomplished by comparing the commercial-grade item to the design criteria of the standard. This standard allows the use of engineering judgment for the acceptance of existing software, and