EN 82304-1:2017
Current
The latest, up-to-date edition.
Health Software - Part 1: General requirements for product safety
01-09-2017
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
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers.It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.
| Committee |
CLC/TC 62
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Current
|
| Standards | Relationship |
| UNE-EN 82304-1:2017 | Identical |
| NF EN 82304-1 : 2017 | Identical |
| NEN EN IEC 82304-1 : 2017 | Identical |
| PN EN 82304-1 : 2017 | Identical |
| I.S. EN 82304-1:2017 | Identical |
| PNE-FprEN 82304-1 | Identical |
| DIN EN 82304-1 : 2018 | Identical |
| VDE 0750-102-1 : 2018 | Identical |
| CEI EN 82304-1 : 1ED 2018 | Identical |
| BS EN 82304-1:2017 | Identical |
| SN EN 82304-1 : 2017 | Identical |
| EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
| UNE-EN 62304:2007 | Medical device software - Software life-cycle processes (IEC 62304:2006) |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| NEMA HN 1 : 2013 | MANUFACTURER DISCLOSURE STATEMENT FOR MEDICAL DEVICE SECURITY |
| 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 |
| EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
| ISO/IEC Guide 63:2012 | Guide to the development and inclusion of safety aspects in International Standards for medical devices |
| 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 |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO/IEC 12207:2008 | Systems and software engineering — 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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