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  • EN ISO 14534:2015

    Current The latest, up-to-date edition.

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

    Available format(s): 

    Language(s): 

    Published date:  28-01-2015

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Safety and performance
    5 Risk assessment
    6 Design
    7 Materials
    8 Clinical evaluation
    9 Manufacturing
    10 Microbiological requirements
    11 Packaging
    12 Shelf-life and discard date
    13 Labelling and information supplied by
       the manufacturer
    Bibliography
    Annex ZA (informative) - Relationship between
             this European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
             on Medical Devices

    Abstract - (Show below) - (Hide below)

    ISO 14534:2011 specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses.ISO 14534:2011 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.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/TC 170
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS 7208-20(1999) : 1999 CONTACT LENSES - OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR THE DETERMINATION OF SHELF-LIFE
    BS 7208-16(1998) : 1998 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 13408-4:2005 Aseptic processing of health care products — Part 4: Clean-in-place technologies
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 18369-1:2017 Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications
    ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    ISO 9394:2012 Ophthalmic optics — Contact lenses and contact lens care products — Determination of biocompatibility by ocular study with rabbit eyes
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
    ISO 13212:2014 Ophthalmic optics — Contact lens care products — Guidelines for determination of shelf-life
    EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
    ISO 13408-2:2003 Aseptic processing of health care products Part 2: Filtration
    ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    EN 868-5:2009 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
    EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 11981:2009 Ophthalmic optics Contact lenses and contact lens care products Determination of physical compatibility of contact lens care products with contact lenses
    ISO 11980:2012 Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations
    EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
    ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    ISO 11140-3:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
    ISO 11986:2010 Ophthalmic optics Contact lenses and contact lens care products Determination of preservative uptake and release
    EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
    ISO 11985:1997 Ophthalmic optics Contact lenses Ageing by exposure to UV and visible radiation (in vitro method)
    ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 13408-3:2006 Aseptic processing of health care products Part 3: Lyophilization
    EN 868-3:2017 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
    ISO 11140-4:2007 Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 18369-2:2017 Ophthalmic optics — Contact lenses — Part 2: Tolerances
    ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    EN 1275:2005 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)
    ISO 11978:2017 Ophthalmic optics — Contact lenses and contact lens care products — Labelling
    ISO 9001:2015 Quality management systems — Requirements
    ISO 12864:1997 Ophthalmic optics Contact lenses Determination of scattered light
    ISO 18369-3:2017 Ophthalmic optics — Contact lenses — Part 3: Measurement methods
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    ISO 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO/TS 19979:2014 Ophthalmic optics Contact lenses Hygienic management of multipatient use trial contact lenses
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    ISO 14729:2001 Ophthalmic optics — Contact lens care products — Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    EN 1040:2005 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)
    ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 11138-4:2017 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
    ISO 18369-4:2017 Ophthalmic optics — Contact lenses — Part 4: Physicochemical properties of contact lens materials
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 11987:2012 Ophthalmic optics — Contact lenses — Determination of shelf-life
    ISO 11138-5:2017 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
    EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place
    ISO 14730:2014 Ophthalmic optics — Contact lens care products — Antimicrobial preservative efficacy testing and guidance on determining discard date
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