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BSI - BS EN ISO 11979-5

Ophthalmic implants — Intraocular lenses Part 5: Biocompatibility

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Organization: BSI
Publication Date: 31 October 2020
Status: active
Page Count: 36
ICS Code (Ophthalmic equipment): 11.040.70

Document History

BS EN ISO 11979-5
October 31, 2020
Ophthalmic implants — Intraocular lenses Part 5: Biocompatibility
A description is not available for this item.
BS EN ISO 11979-5
June 30, 2006
Ophthalmic implants Intraocular lenses Part 5: Biocompatibility
A description is not available for this item.

References

This document references:
ISO TS 21726 - Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
Published by ISO on February 1, 2019
This document describes the basis for, selection of, and general applicability of a threshold of toxicological concern (TTC) value for a constituent present in/on a medical device or released from a...
This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
ISO 10993-6 FRENCH - Évaluation biologique des dispositifs médicaux - Partie 6: Essais concernant les effets locaux après implantation
Published by ISO on December 1, 2016
A description is not available for this item.
This document references:
ISO 10993-3 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Published by ISO on October 1, 2014
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially...
This document references:
ISO 11979-1 - Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
Published by ISO on November 1, 2018
This document defines terms applicable to intraocular lenses, and to the methods used to evaluate them. NOTE Terms are listed in the alphabetical order of the English terms in the English version of...
This document is referenced by:
BS EN ISO 10993-6 - TC - Tracked Changes (Redline) - Biological evaluation of medical devices Part 6: Tests for local effects after implantation
Published by BSI on February 24, 2020
A description is not available for this item.
This document is referenced by:
BS EN ISO 11979-10 - TC - Tracked Changes (Redline) - Ophthalmic implants - Intraocular lenses Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
Published by BSI on February 26, 2020
A description is not available for this item.
This document is referenced by:
BS EN ISO 11979-8 - Ophthalmic implants - Intraocular lenses Part 8: Fundamental requirements
Published by BSI on June 30, 2017
A description is not available for this item.
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