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BSI - BS EN ISO 14534 - TC

Tracked Changes (Redline) - Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements

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Organization: BSI
Publication Date: 26 February 2020
Status: active
Page Count: 43
ICS Code (Ophthalmic equipment): 11.040.70

Document History

BS EN ISO 14534 - TC
February 26, 2020
Tracked Changes (Redline) - Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements
A description is not available for this item.

References

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 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Published by ISO on June 1, 2009
This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts...
This document references:
ISO 22442-3 - Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
Published by ISO on December 15, 2007
A description is not available for this item.
This document references:
ISO 11140-5 - Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dicktype air removal tests
Published by ISO on March 15, 2007
A description is not available for this item.
This document references:
ISO 18369-2 - Ophthalmic optics - Contact lenses - Part 2: Tolerances
Published by ISO on August 1, 2017
This document specifies the tolerance limits of the principal optical and physical parameters of rigid corneal, rigid scleral and soft contact lenses at the time of manufacture. These tolerances...
This document references:
ISO 18369-2 - Ophthalmic optics - Contact lenses - Part 2: Tolerances
Published by ISO on August 1, 2017
This document specifies the tolerance limits of the principal optical and physical parameters of rigid corneal, rigid scleral and soft contact lenses at the time of manufacture. These tolerances...
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