UNE-EN 62304:2007
Current
Current
The latest, up-to-date edition.
Medical device software - Software life-cycle processes (IEC 62304:2006)
Amended by
Available format(s)
Hardcopy , PDF
Published date
28-03-2007
Publisher
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CTN 209/SC 62A
|
| DocumentType |
Standard
|
| Pages |
84
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Current
|
| Standards | Relationship |
| NBN EN 62304 : 2007 | Identical |
| EN 62304:2006/A1:2015 | Identical |
| DIN EN 62304 : 2016 | Identical |
| IEC 62304:2006+AMD1:2015 CSV | Identical |
| BS EN 62304 : 2006 | Identical |
| I.S. EN 62304:2006 | Identical |
| IEC 62304:2006 | Identical |
| NF EN 62304 : 2006 AMD 1 2018 | Identical |
| EN 61508-3:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements |
| ISO/IEC 15504-5:2012 | Information technology Process assessment Part 5: An exemplar software life cycle process assessment model |
| IEEE 610.12-1990 | IEEE Standard Glossary of Software Engineering Terminology |
| ISO/IEC 25010:2011 | Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — System and software quality models |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO/IEC 33001:2015 | Information technology Process assessment Concepts and terminology |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| ISO/IEC 14764:2006 | Software Engineering — Software Life Cycle Processes — Maintenance |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
| IEC 61508-3:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508) |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| ISO/IEC 12207:2008 | Systems and software engineering — Software life cycle processes |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| EN 61010-1:2010 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| EN 60601-1-4:1996/A1:1999 | MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
| ISO/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
| EN 82304-1:2017 | Health Software - Part 1: General requirements for product safety |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| EN 62366-1:2015/AC:2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015) |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| EN ISO 9000:2015 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
| ISO/IEC 33004:2015 | Information technology Process assessment Requirements for process reference, process assessment and maturity models |
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