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EN ISO 18113-2:2011 Standard

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  Keywords:

#part #ivd #applies #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 - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

  Purpose

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use. This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to a) IVD instruments or equipment, b) IVD reagents for self-testing.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 18113-2:2009"

Anyway is still possible use the "EN ISO 18113-2:2009" until April 30th, 2012

  Related Standards

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 ISO 17511:2003

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

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assign...

EN 13532:2002

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

EN 13612:2002/AC:2002

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

Performance evaluation of in vitro diagnostic medical devices

EN 13641:2002

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

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

EN 13975:2003

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

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

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