ÖVE/ÖNORM EN 45502-1:2016-03

Действует

Implants for surgery - Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (english version)

Описание Изменения Ссылки Версии

Ссылочные документы

IEC 60068-2-14:2009 ed6.0

Заменен

Environmental testing - Part 2-14: Tests - Test N: Change of temperature — 37 стр.

IEC 60068-2-27:2008 ed4.0

Действует

Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock — 75 стр.

IEC 60068-2-47:2005 ed3.0

Действует

Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests — 69 стр.

IEC 60068-2-64:2008 ed2.0

Действует

Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance — 71 стр.

IEC 60601-1:2005 ed3.0

Действует

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance — 777 стр.

IEC 62304:2006 ed1.0

Действует

Medical device software - Software life cycle processes — 78 стр.

IEC 62366:2007 ed1.0

Заменен

Medical devices - Application of usability engineering to medical devices — 209 стр.

ISO 11607-1:2006

Действует

Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems — 32 стр.

ISO 14155:2011

Действует

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

ISO 14971:2007

Действует

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

ISO 8601:2004

Действует

Data elements and interchange formats -- Information interchange -- Representation of dates and times — 40 стр.

BS EN 60068-2-14:2009

Действует

Environmental testing. Tests. Test N. Change of temperature — 20 стр.

BS EN 60068-2-27:2009

Действует

Environmental testing. Tests. Test Ea and guidance. Shock — 44 стр.

BS EN 60068-2-47:2005

Действует

Environmental testing. Tests. Mounting of specimens for vibration, impact and similar dynamic tests — 38 стр.

BS EN 60068-2-64:2008

Действует

Environmental testing. Tests. Test Fh. Vibration, broadband random and guidance — 36 стр.

BS EN 62304:2006

Заменен

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

BS EN 62366:2008

Заменен

Medical devices. Application of usability engineering to medical devices — 104 стр.

BS EN ISO 10993-1:2009

Заменен

Biological evaluation of medical devices. Evaluation and testing within a risk management process — 32 стр.

BS EN ISO 11607-1:2006

Заменен

Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems — 36 стр.

ÖNORM EN ISO 14155:2011-05

Заменен

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

BS EN ISO 14971:2012

Действует

Medical devices. Application of risk management to medical devices — 104 стр.