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DIN EN ISO 14534

Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)

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Organization: DIN
Publication Date: 1 August 2015
Status: active
Page Count: 23
ICS Code (Ophthalmic equipment): 11.040.70
scope:

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 not specify electrical safety and electromagnetic compatibility considerations that might arise from the use of electrical equipment in conjunction with contact lenses or contact lens care products.

Document History

DIN EN ISO 14534
August 1, 2015
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
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...
DIN EN ISO 14534
June 1, 2011
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
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...
DIN EN ISO 14534
July 1, 2009
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)
A description is not available for this item.
DIN EN ISO 14534/A1
January 1, 2009
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002); English version prEN ISO 14534:2008, Amendment 1
A description is not available for this item.
DIN EN ISO 14534
October 1, 2002
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)
A description is not available for this item.
DIN EN ISO 14534
April 1, 1998
Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:1997)
A description is not available for this item.
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References

This document references:
DIN EN ISO 11978 - Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017 + Amd 1:2020) (includes Amendment :2020)
Published by DIN on April 1, 2021
A description is not available for this item.
This document references:
DIN EN ISO 11981 - Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses (ISO 11981:2017)
Published by DIN on April 1, 2018
This document describes the general procedure and performance criteria for assessing the physical compatibility of contact lens care products with contact lenses and for determining whether the...
This document references:
EN 1040 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
Published by CEN on December 1, 2005
A description is not available for this item.
This document references:
EN 1041 - Information supplied by the manufacturer of medical devices
Published by CEN on August 1, 2008
This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical...
This document references:
DIN EN ISO 18369-1 - Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications (ISO 18369-1:2017, Corrected version 2017-10-01)
Published by DIN on April 1, 2018
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 references:
DIN EN ISO 18369-3 - Ophthalmic optics - Contact lenses - Part 3: Measurement methods (ISO 18369-3:2017, Corrected version 2017-10-01)
Published by DIN on April 1, 2018
This document specifies the methods for measuring the physical and optical properties of contact lenses specified in ISO 18369-2, i.e. radius of curvature, label back vertex power, diameter,...
This document references:
EN 1275 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
Published by CEN on December 1, 2005
A description is not available for this item.
This document references:
EN 556-1 - Sterilization of Medical Devices - Requirements for Medical Devices to Be Designated "Sterile" - Part 1: Requirements for Terminally Sterilized Medical Devices
Published by CEN on October 1, 2001
This European Standard specifies the requirements for a terminally-sterilized medical device to be designated "STERILE". Part 2 of this European Standard specifies the requirements for an aseptically...
This document references:
EN 556-2 - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
Published by CEN on September 1, 2015
This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose of the EU Directive(s) for medical devices (see...
This document references:
DIN EN ISO 11978 - Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017 + Amd 1:2020) (includes Amendment :2020)
Published by DIN on April 1, 2021
A description is not available for this item.
This document references:
DIN EN ISO 11981 - Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses (ISO 11981:2017)
Published by DIN on April 1, 2018
This document describes the general procedure and performance criteria for assessing the physical compatibility of contact lens care products with contact lenses and for determining whether the...
This document references:
DIN EN ISO 18369-1 - Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications (ISO 18369-1:2017, Corrected version 2017-10-01)
Published by DIN on April 1, 2018
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 references:
DIN EN ISO 18369-3 - Ophthalmic optics - Contact lenses - Part 3: Measurement methods (ISO 18369-3:2017, Corrected version 2017-10-01)
Published by DIN on April 1, 2018
This document specifies the methods for measuring the physical and optical properties of contact lenses specified in ISO 18369-2, i.e. radius of curvature, label back vertex power, diameter,...
View Less
View All
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