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EN 13975:2003 Standard

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  Keywords:

#european #standard #specifies #sampling #procedure

  Directive

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

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

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

  Purpose

This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EC verification by a notified body

  Publication

Friday 17th of November 2017

  Related Standards

EN 556-1:2001

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

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN 556-1:2001/AC:2006

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

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN 556-2:2015

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

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

EN ISO 11137-2:2015

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

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

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

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