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ISO 9394

Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes

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Organization: ISO
Publication Date: 1 October 2012
Status: active
Page Count: 20
ICS Code (Ophthalmic equipment): 11.040.70
scope:

This International Standard specifies an in vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products. The test assesses the degree of irritation to the ocular tissue produced by the device under test. The test method is described in application to rabbit eyes.

Document History

ISO 9394
October 1, 2012
Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
This International Standard specifies an in vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products. The test assesses the degree of...
ISO 9394
August 15, 1998
Ophthalmic Optics - Contact Lenses and Contact Lens Care Products - Determination of Biocompatibilty by Ocular Study with Rabbit Eyes
This International Standard specifies an in vivo method of test to assess the ocular safety of contact lenses and contact lens care products. The test assesses the degree of irritation to the ocular...
ISO 9394
November 15, 1994
Optics and Optical Instruments - Determination of Biological Compatibility of Contact Lens Materials - Testing of the Contact Lens System by Ocular Study with Rabbit Eyes
A description is not available for this item.

References

This document references:
ISO 10993-2 - Biological evaluation of medical devices Part 2: Animal welfare requirements
Published by ISO on July 15, 2006
This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical...
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 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 18369-1 - Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
Published by ISO on August 1, 2017
This document identifies and defines the terms applicable to the physical, chemical and optical properties of contact lenses, their manufacture and uses. It provides a vocabulary of terms and, when...
This document is referenced by:
EN ISO 14534 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements
Published by CEN on January 1, 2015
This International Standard specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses. This International Standard does...
This document is referenced by:
AAMI 10993-10 - Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
Published by AAMI on January 1, 2010
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This...
This document is referenced by:
DIN EN ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
Published by DIN on October 1, 2014
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This...
This document is referenced by:
DIN EN ISO 14534 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2015
Published by DIN on August 1, 2015
Diese Internationale Norm legt Anforderungen an die Sicherheit und Funktion von Kontaktlinsen, Kontakt-linsenpflegemitteln und anderem Zubehör für Kontaktlinsen fest. Diese Internationale Norm legt...
This document is referenced by:
10993-10 - Biological evaluation of medical devices — Part 10: Tests for skin sensitization
Published by ISO on November 1, 2021
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: —...
This document is referenced by:
DIN EN ISO 14534 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
Published by DIN on August 1, 2015
This International Standard specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses. This International Standard does...
This document is referenced by:
10993-10 - Biological evaluation of medical devices — Part 10: Tests for skin sensitization
Published by ISO on November 1, 2021
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: —...
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