BS EN 62304:2006+A1:2015

Действует

Medical device software. Software life-cycle processes — 88 стр.

Ссылочные документы

IEC 60601-1:2005/COR1:2012+AMD1:2012 CSV ed3.1

Действует

Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance — 0 стр.

BS EN 60601-1:2006

Заменен

Medical electrical equipment. General requirements for basic safety and essential performance — 384 стр.

IEC 60601-1-4:1996 ed1.0

Отменен

Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems — 61 стр.

ISO 14971:2007

Действует

Medical devices -- Application of risk management to medical devices — 90 стр.

ISO 9001:2008

Заменен

Quality management systems -- Requirements — 36 стр.

BS EN ISO 9001:2008

Заменен

Quality management systems. Requirements — 40 стр.

ISO 13485:2003

Заменен

Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.

BS EN ISO 13485:2003

Заменен

Medical devices. Quality management systems. Requirements for regulatory purposes — 72 стр.

IEC 62366-1:2015/COR1:2016 ed1.0

Действует

Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices — 0 стр.

BS EN 62366-1:2015

Действует

Medical devices. Application of usability engineering to medical devices — 54 стр.

IEC 82304-1:2016 ed1.0

Действует

Health software - Part 1: General requirements for product safety — 55 стр.

BS EN 82304-1:2017

Действует

BS EN 82304-1 Health Software -. Part 1: General requirements for product safety — 34 стр.

BS ISO/IEC 33001:2015

Действует

Information technology. Process assessment. Concepts and terminology — 28 стр.

BS ISO/IEC 33004:2015

Действует

Information technology. Process assessment. Requirements for process reference, process assessment and maturity models — 18 стр.

ISO/IEC 90003:2014

Действует

Software engineering -- Guidelines for the application of ISO 9001:2008 to computer software — 62 стр.

ISO/IEC Guide 51:2014

Действует

Safety aspects -- Guidelines for their inclusion in standards — 22 стр.

IEC 60601-1-6:2010 ed3.0

Действует

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability — 51 стр.

BS EN 60601-1-6:2010

Действует

Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability — 26 стр.

IEC 61508-3:1998/COR1:1999 ed1.0

Заменен

Corrigendum 1 - Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements — 1 стр.

BS EN 61508-3:2010

Действует

Functional safety of electrical/electronic/ programmable electronic safety-related systems. Software requirements — 114 стр.

IEC 61010-1:2010 ed3.0

Действует

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements — 322 стр.

BS EN 61010-1:2010

Действует

Safety requirements for electrical equipment for measurement, control, and laboratory use. General requirements — 162 стр.

ISO 9000:2005

Заменен

Quality management systems -- Fundamentals and vocabulary — 38 стр.

BS EN ISO 9000:2005

Заменен

Quality management systems. Fundamentals and vocabulary — 42 стр.

ISO/IEC 12207:2008

Действует

Systems and software engineering -- Software life cycle processes — 123 стр.

ISO/IEC 15504-5:2012

Действует

Information technology -- Process assessment -- Part 5: An exemplar software life cycle process assessment model — 206 стр.

ISO/IEC 25010:2011

Действует

Systems and software engineering -- Systems and software Quality Requirements and Evaluation (SQuaRE) -- System and software quality models — 44 стр.

BS EN 62304:2006

Заменен

Medical device software. Software life-cycle processes — 80 стр.

На этот документ ссылаются

BS EN 62304:2006

Заменен

Medical device software. Software life-cycle processes — 80 стр.

BS EN 16844:2017+A1:2018

Действует

Aesthetic medicine services. Non-surgical medical treatments — 54 стр.

BS EN 61010-2-040:2015

Действует

Safety requirements for electrical equipment for measurement, control, and laboratory use. Particular requirements for sterilizers and washer-disinfectors used to treat medical materials — 42 стр.

BS EN 285:2015

Действует

Sterilization. Steam sterilizers. Large sterilizers — 104 стр.

BS EN 60601-2-66:2015

Действует

Medical electrical equipment. Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems — 62 стр.

BS EN 13060:2014+A1:2018

Действует

Small steam sterilizers — 86 стр.

BS EN 13060:2014

Заменен

Small steam sterilizers — 82 стр.