18/30370883 DC

Действует

BS EN ISO 14971. Medical devices. Application of risk management to medical devices — 53 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.

ISO 31000:2018

Действует

Risk management -- Guidelines — 24 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.

ISO 13485:2016

Действует

Medical devices -- Quality management systems -- Requirements for regulatory purposes — 46 стр.

ISO 9000:2015

Действует

Quality management systems -- Fundamentals and vocabulary — 58 стр.

IEC TR 60513:1994 ed2.0

Действует

Fundamental aspects of safety standards for medical electrical equipment — 125 стр.

ISO 10993-1:2009

Заменен

Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 28 стр.

ISO 14155:2011

Действует

Clinical investigation of medical devices for human subjects -- Good clinical practice — 66 стр.

ISO 18113-1:2009

Действует

In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements — 56 стр.