Стандарты ON

ÖNORM EN ISO 5367:2015-01

Действует

Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)

Описание Изменения Ссылки Версии

Ссылочные документы

ISO 5356-1:2015

Действует

Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets — 24 стр.

ISO 7000:2014

Действует

Graphical symbols for use on equipment -- Registered symbols — 1 стр.

ISO 10993-1:2009/Cor.1:2010

Заменен

Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process -- Technical Corrigendum 1 — 1 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 14971:2007

Действует

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

ISO 15223-1:2012

Заменен

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements — 30 стр.

IEC 60417:1973/COR1:2004 ed1.0

Заменен

Corrigendum 1 - Graphical symbols for use on equipment — 0 стр.

IEC 60601-1:2005 ed3.0

Действует

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

IEC 62366:2007+AMD1:2014 CSV ed1.1

Заменен

Medical devices - Application of usability engineering to medical devices — 436 стр.

ISO 80601-2-12:2011

Действует

Medical electrical equipment -- Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators — 88 стр.

ISO 80601-2-13:2011

Действует

Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation — 108 стр.

BS EN 556-1:2001

Действует

Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices — 12 стр.

ÖNORM EN 1041:2013-11

Действует

Information supplied by the manufacturer of medical devices

ÖNORM EN 12342:2010-02

Заменен

Breathing tubes intended for use with anaesthetic apparatus and ventilators

На этот документ ссылаются

DIN EN ISO 2758:2014-12

Действует

Paper - Determination of bursting strength (ISO 2758:2014); German version EN ISO 2758:2014 — 20 стр.

DIN EN ISO 2759:2014-10

Действует

Board - Determination of bursting strength (ISO 2759:2014); German version EN ISO 2759:2014 — 22 стр.

DIN EN ISO 2759:2003-11

Отменен

Board - Determination of bursting strength (ISO 2759:2001); German version EN ISO 2759:2003 — 19 стр.

DIN EN ISO 2758:2003-11

Отменен

Paper - Determination of bursting strength (ISO 2758:2001); German version EN ISO 2758:2003 — 21 стр.

DIN EN ISO 2758:2014-02

Отменен

Paper - Determination of bursting strength (ISO/FDIS 2758:2013); German version FprEN ISO 2758:2013 — 20 стр.

DIN EN ISO 2759:2014-02

Отменен

Board - Determination of bursting strength (ISO/FDIS 2759:2013); German version FprEN ISO 2759:2013 — 22 стр.

ÖNORM EN 12342:2010-02

Заменен

Breathing tubes intended for use with anaesthetic apparatus and ventilators