본 문서는 다음과 같은 문서를 참고하여 개발한다. 만약 개별 프로젝트에서만 참고하는 문서가 있는 경우에는 해당 프로젝트 개발 계획 문서에 참고 문서를 명시한다.
This document refers the following documents. If an individual project references another document, the reference document must be specified in the software development plan document for the project.
| 약어 Acronym | 문서 이름 Document Name |
|---|---|
| IEC 60601-1:2012 | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-6:2013 | Medical electrical equipment – Part1-6 General requirements for basic safety and essential performance |
| IEC 62304:2015 | Medical device software – Software life cycle processes, 2015 |
| IEC 62366-1:2015 | Medical devices – Application of usability engineering to medical devices |
| ISO 13485:2016 | Medical devices – Quality management systems, 2016 |
| ISO 14971:2012 | Medical devices – Application of risk management to medical devices, 2012 |
| ISO 15223-1:2012 | Symbols to be used with medical device labels, labelling and information to be supplied, 2012 |
| ISO/IEC 27000:2018 | Information technology — Security techniques — Information security management systems — Overview and vocabulary, 2018 |
| FDA DI:2016 | Data Integrity and Compliance With CGMP Guidance for Industry Draft Guidance, FDA, 2016 |
| KFDA CS:2022 | 의료기기의 사이버보안 허가,심사 가이드라인 [민원인 안내서], 식품의약안전처, 2022 |
| KFDA RM:2017 | 의료기기의 전기,기계적 안전에 관한 공통기준규격 실무안내서 – 위험관리, 식품의약안전처, 2017 |
| SCMTREE | Brad Appleton et. al., Streamed Lines: Branching Patterns for Parallel Software Development, PLoP ’98 Conference, 1998 |
| RUP | Rational Unified Process: Best Practices for Software Development Teams |