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)

DocumentType	Standard
Pages	23
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current
Supersedes	DIN EN ISO 14534:2011-06

Standards	Relationship
NS EN ISO 14534 : 2015	Identical
NBN EN ISO 14534 : 2015	Identical
UNI EN ISO 14534 : 2011	Identical
UNE-EN ISO 14534:2015	Identical
EN ISO 14534:2015	Identical
NEN EN ISO 14534 : 2015	Identical
I.S. EN ISO 14534:2015	Identical
BS EN ISO 14534:2015	Identical
ISO 14534:2011	Identical
NF EN ISO 14534 : 2015	Identical
SN EN ISO 14534:2015	Identical

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)
DIN EN ISO 13212:2014-12	OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR DETERMINATION OF SHELF-LIFE (ISO 13212:2014)

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
DIN EN ISO 18369-2:2016-06 (Draft)	OPHTHALMIC OPTICS - CONTACT LENSES - PART 2: TOLERANCES (ISO 18369-2:2017)
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
DIN EN ISO 15223-1:2015-08 (Draft)	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
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
DIN EN ISO 18369-4:2016-06 (Draft)	OPHTHALMIC OPTICS - CONTACT LENSES - PART 4: PHYSICOCHEMICAL PROPERTIES OF CONTACT LENS MATERIALS (ISO 18369-4:2017, CORRECTED VERSION 2017-10-01)
ISO 11138-3:2017	Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
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)
DIN EN ISO 18369-3:2016-06 (Draft)	OPHTHALMIC OPTICS - CONTACT LENSES - PART 3: MEASUREMENT METHODS (ISO 18369-3:2017, CORRECTED VERSION 2017-10-01)
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 11138-3:2015-10 (Draft)	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES (ISO 11138-3:2017)
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
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
DIN EN ISO 18369-1:2016-06 (Draft)	OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: VOCABULARY, CLASSIFICATION SYSTEM AND RECOMMENDATIONS FOR LABELLING SPECIFICATIONS (ISO 18369-1:2017, CORRECTED VERSION 2017-10-01)
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
DIN EN ISO 11137-3:2015-08 (Draft)	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017)
DIN EN ISO 11138-2:2015-10 (Draft)	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES (ISO 11138-2:2017)
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 11138-1:2015-10 (Draft)	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
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
DIN EN ISO 11138-5:2015-10 (Draft)	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES (ISO 11138-5:2017)
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 11138-4:2015-10 (Draft)	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES (ISO 11138-4:2017)
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