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EN ISO 18113-1:2011 Standard

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  Keywords:

#part #ivd #instrument #use #investigational

  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 1: Terms, definitions and general requirements (ISO 18113-1:2009)

  Purpose

This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations. This part of ISO 18113 does not apply to a) IVD devices for performance evaluation (e.g., for investigational use only), b) instrument marking, c) material safety data sheets.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 18113-1:2009"

Anyway is still possible use the "EN ISO 18113-1:2009" until April 30th, 2012

  Related Standards

EN 13641:2002

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

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EN ISO 13408-4:2011

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Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

EN 13612:2002/AC:2002

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

Performance evaluation of in vitro diagnostic medical devices

EN 13612:2002

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

Performance evaluation of in vitro diagnostic medical devices

EN 13532:2002

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

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

EN ISO 13408-7:2015

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

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

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