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EN 61508-3:2010
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Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements |
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ISO/IEC 15504-5:2012
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Information technology Process assessment Part 5: An exemplar software life cycle process assessment model |
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IEEE 610.12-1990
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IEEE Standard Glossary of Software Engineering Terminology |
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ISO/IEC 25010:2011
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Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — System and software quality models |
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IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
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ISO/IEC 33001:2015
|
Information technology Process assessment Concepts and terminology |
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IEC 60601-1-6:2010+AMD1:2013 CSV
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Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
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ISO/IEC 14764:2006
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Software Engineering Software Life Cycle Processes Maintenance |
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ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
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EN 60601-1-6:2010/A1:2015
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
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IEC 61508-3:2010
|
Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508) |
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ISO/IEC Guide 51:2014
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Safety aspects Guidelines for their inclusion in standards |
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EN ISO 9001:2015
|
Quality management systems - Requirements (ISO 9001:2015) |
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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
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MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
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ISO/IEC 90003:2014
|
Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
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EN 82304-1:2017
|
Health Software - Part 1: General requirements for product safety |
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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 |