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  • DIN EN ISO 14534:2015-08

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

    Available format(s):  Hardcopy, PDF

    Language(s):  English, German

    Published date:  01-08-2015

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current
    Supersedes

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

    DIN EN ISO 13212:2014-12 OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR DETERMINATION OF SHELF-LIFE (ISO 13212:2014)
    DIN EN ISO 14729:2011-01 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses (ISO 14729:2001 + Amd.1:2010); German version EN ISO 14729:2001 + A1:2010
    DIN EN ISO 14730:2015-02 OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - ANTIMICROBIAL PRESERVATIVE EFFICACY TESTING AND GUIDANCE ON DETERMINING DISCARD DATE (ISO 14730:2014)

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

    ISO 13408-4:2005 Aseptic processing of health care products Part 4: Clean-in-place technologies
    DIN EN ISO 11607-1:2014-11 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014)
    DIN EN ISO 11986:2011-02 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF PRESERVATIVE UPTAKE AND RELEASE (ISO 11986:2017)
    DIN EN ISO 13212:2014-12 OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR DETERMINATION OF SHELF-LIFE (ISO 13212:2014)
    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
    DIN EN ISO 12864:1998-02 OPHTHALMIC OPTICS - CONTACT LENSES - DETERMINATION OF SCATTERED LIGHT
    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
    EN 556-1:2001/AC:2006 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED "STERILE" - PART 1: REQUIREMENTS FOR TERMINALLY STERILIZED MEDICAL DEVICES
    DIN EN ISO 13485:2016-08 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    DIN EN ISO 11978:2015-02 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - LABELLING (ISO 11978:2017)
    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
    DIN EN ISO 13408-6:2013-07 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013)
    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
    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
    DIN EN ISO 11137-1:2015-11 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013)
    ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    DIN EN ISO 13408-3:2011-09 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
    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
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    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)
    DIN EN ISO 13408-2:2011-09 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
    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
    DIN EN ISO 13408-1:2015-12 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
    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
    DIN EN ISO 17665-1:2006-11 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 17665-1:2006)
    DIN EN ISO 10993-5:2009-10 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
    ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
    DIN EN ISO 13408-4:2011-09 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
    DIN EN ISO 13408-5:2011-09 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
    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
    DIN EN ISO 10993-12:2012-10 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
    DIN EN ISO 11607-2:2014-11 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014)
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    DIN EN ISO 11135-1:2007-08 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    DIN EN ISO 11140-4:2007-07 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 11140-4:2007)
    DIN EN ISO 11737-2:2010-04 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    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
    DIN EN ISO 11140-3:2009-09 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
    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)
    DIN EN ISO 11981:2009-12 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF PHYSICAL COMPATIBILITY OF CONTACT LENS CARE PRODUCTS WITH CONTACT LENSES (ISO 11981:2017)
    DIN EN ISO 14155:2012-01 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011)
    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
    DIN EN ISO 10993-10:2014-10 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
    ISO 18369-3:2017 Ophthalmic optics Contact lenses Part 3: Measurement methods
    DIN EN ISO 18472:2006-10 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    DIN EN ISO 9394:2013-01 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)
    DIN EN ISO 9001:2015-11 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
    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
    DIN EN ISO 14730:2015-02 OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - ANTIMICROBIAL PRESERVATIVE EFFICACY TESTING AND GUIDANCE ON DETERMINING DISCARD DATE (ISO 14730:2014)
    ISO 14729:2001 Ophthalmic optics Contact lens care products Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
    DIN EN ISO 11737-1:2009-09 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
    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
    DIN EN ISO 10993-9:2010-04 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
    ISO 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place
    DIN EN ISO 11140-1:2015-03 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    ISO 14730:2014 Ophthalmic optics Contact lens care products Antimicrobial preservative efficacy testing and guidance on determining discard date
    DIN EN ISO 10993-3:2015-02 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY (ISO 10993-3:2014)
    DIN EN ISO 14729:2011-01 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses (ISO 14729:2001 + Amd.1:2010); German version EN ISO 14729:2001 + A1:2010
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