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EN ISO 11979-8:2009 Standard

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  Keywords:

#eye #excluding #corneal #implants #ophthalmic

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)

  Purpose

This part of ISO 11979 specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 11979-8:2006"

Anyway is still possible use the "EN ISO 11979-8:2006" until March 21st, 2010

  Related Standards

EN ISO 25539-1:2009

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EN ISO 9713:2009

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Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)

EN 12006-2:1998+A1:2009

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Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including c...

EN ISO 15798:2010

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Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)

EN ISO 16061:2009

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Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version...

EN ISO 21534:2009

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Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)

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