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:
oftware requirements (4) Part 4: Definitions and abbreviations (5) Part 5: Examples of methods for the determination of safety integrity levels (6) Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3 (i.e., Parts 2 and 3) (7) Part 7: Overview of techniques and measures The goal of IEC 61508, and of functional safety in general, is for the automatic safety functions to perform their intended functions correctly or for the system to fail in a safe and predictable manner. The standard focuses attention on risk-based safety-related system design and requires the attention to detail that is vital to safe system design. Manufacturers of electronic and programmable electronic equipment for safety applications seek independent third-party certification to ensure functional safety in accordance with IEC 61508. This certification verifies key criteria within IEC 61508 to demonstrate the reliability goals and the systematic capability requirements for a targeted SIL. Compliance is evaluated by accredited third-party certifying bodies that assess and certify that a product has been designed and developed in accordance with the standard. The certifying bodies follow a rigorous process that verifies that a product’s hardware and software design as well as its manufacturing and quality control procedures satisfy the IEC 61508 requirements established for the product’s SIL claim. The certifying bodies also verify the product’s built- in fault detection capabilities in addition to performing a failure modes, effects, and diagnostics analysis to ascertain failure rate data needed for use in verifying the SIL. The certifying bodies also analyze a device’s failure data in actual field experience (historical use). Upon completion of the verification and analysis process, 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