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EN ISO 11197:2009 Standard

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  Keywords:

#applies #document #particular #take #requirements

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical supply units (ISO 11197:2004)

  Purpose

Clause 1 of EN 60601-1:1990 applies with the following addition: This document applies to medical supply units as defined in 3.5. This particular document applies in conjunction with EN 60601-1. The requirements of this particular document take priority over those of EN 60601-1.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 11197:2004"

Anyway is still possible use the "EN ISO 11197:2004" until March 21st, 2010

  Related Standards

EN ISO 8359:2009

Medical devices Directive (93/42/EEC)

Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)

EN ISO 10993-11:2018

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

EN 1060-3:1997+A2:2009

Medical devices Directive (93/42/EEC)

Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

EN 1282-2:2005+A1:2009

Medical devices Directive (93/42/EEC)

Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

EN 1422:1997+A1:2009

Medical devices Directive (93/42/EEC)

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

EN 1782:1998+A1:2009

Medical devices Directive (93/42/EEC)

Tracheal tubes and connectors

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