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EN 12322:1999/A1:2001 Standard

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  Keywords:

#media #microbiological #laboratories #vitro #diagnostic

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

  Purpose

This standard specifies requirements for the performance of culture media. It is concerned with the traceability, comparability, reproducibility and suitability of culture media used in microbiological laboratories.

  Publication

Friday 17th of November 2017

  Amendment

This standard is an amendment for "EN 12322:1999"

  Reference

This standard supersedes the "EN 12322:1999"

Anyway is still possible use the "EN 12322:1999" until April 30th, 2002

  Related Standards

EN 13975:2003

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Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

EN 14254:2004

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In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

EN ISO 11737-2:2009

In vitro diagnostic medical devices Directive (98/79/EC)

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation an...

EN 12322:1999

In vitro diagnostic medical devices Directive (98/79/EC)

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

EN ISO 13408-7:2015

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Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

EN 13532:2002

In vitro diagnostic medical devices Directive (98/79/EC)

General requirements for in vitro diagnostic medical devices for self-testing

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