Need help?

EN ISO 11197:2009 Standard

wave
Save  

  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 9170-2:2008

Medical devices Directive (93/42/EEC)

Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)

EN 1041:2008

Medical devices Directive (93/42/EEC)

Information supplied by the manufacturer of medical devices

EN ISO 15747:2019

Medical devices Directive (93/42/EEC)

Plastic containers for intravenous injections (ISO 15747:2018)

EN ISO 15883-4:2018

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endo...

EN ISO 17664:2017

Medical devices Directive (93/42/EEC)

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical d...

EN ISO 21987:2017

Medical devices Directive (93/42/EEC)

Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2017)

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 11197:2009 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0