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UNE-EN 62304:2007

Current
Current

The latest, up-to-date edition.

Medical device software - Software life-cycle processes (IEC 62304:2006)
Available format(s)

Hardcopy , PDF

Published date

03-28-2007

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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