15/30246774 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
Hardcopy , PDF
English
31-03-2017
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 HEALTH SOFTWARE PRODUCT requirements
5 HEALTH SOFTWARE - Software life cycle processes
6 HEALTH SOFTWARE PRODUCT VALIDATION
7 HEALTH SOFTWARE PRODUCT identification and
ACCOMPANYING DOCUMENTS
8 Post-market activities for the HEALTH SOFTWARE PRODUCT
Annex A (informative) - Rationale
Bibliography
Index
BS EN 82304-1.
| Committee |
CH/62/1
|
| DocumentType |
Draft
|
| Pages |
29
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO/IEC 14764:2006 | Software Engineering — Software Life Cycle Processes — Maintenance |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| IEC TR 80001-2-2:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| IEC 61907:2009 | Communication network dependability engineering |
| ISO/TR 17791:2013 | Health informatics — Guidance on standards for enabling safety in health software |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
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