ISO 14534:2011
Current
Current
The latest, up-to-date edition.
Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, French, Russian
Published date
22-03-2011
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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.
| DevelopmentNote |
Supersedes ISO/DIS 14534. (03/2011)
|
| DocumentType |
Standard
|
| Pages |
10
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| AS/NZS ISO 14534:2023 | Identical |
| UNE-EN ISO 14534:2015 | Identical |
| UNE-EN ISO 14534:2011 | Identical |
| GOST R ISO 14534 : 2013 | Identical |
| NF EN ISO 14534 : 2015 | Identical |
| NBN EN ISO 14534 : 2015 | Identical |
| NEN EN ISO 14534 : 2015 | Identical |
| NS EN ISO 14534 : 2015 | Identical |
| I.S. EN ISO 14534:2015 | Identical |
| I.S. EN ISO 14534:2011 | Identical |
| PN EN ISO 14534 : 2015 | Identical |
| SN EN ISO 14534:2015 | Identical |
| UNI EN ISO 14534 : 2011 | Identical |
| SS-EN ISO 14534 : 2015 | Identical |
| BS EN ISO 14534:2015 | Identical |
| BS EN ISO 14534:2011 | Identical |
| EN ISO 14534:2015 | Identical |
| DIN EN ISO 14534:2015-08 | Identical |
| DIN EN ISO 14534:2011-06 | Identical |
| 04/30088797 DC : DRAFT APR 2004 | ISO 18369 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 3: MEASUREMENT METHODS |
| 13/30266987 DC : 0 | BS EN ISO 13212 - OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR DETERMINATION OF SHELF-LIFE |
| DD ISO/TS 19979:2004 | Ophthalmic optics. Contact lenses. Hygienic management of multipatient use trial contact lenses |
| ISO 11978:2017 | Ophthalmic optics — Contact lenses and contact lens care products — Labelling |
| 16/30310659 DC : 0 | BS EN ISO 18369-2 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 2: TOLERANCES |
| BS 7208-25(2000) : 2000 | OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - ANTIMICROBIAL PRESERVATIVE EFFICACY TESTING AND GUIDANCE ON DETERMINING DISCARD DATE |
| I.S. EN ISO 18369-2:2017 | OPHTHALMIC OPTICS - CONTACT LENSES - PART 2: TOLERANCES (ISO 18369-2:2017) |
| I.S. EN ISO 11978:2017 | OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - LABELLING (ISO 11978:2017) |
| I.S. EN ISO 18369-1:2017 | OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: VOCABULARY, CLASSIFICATION SYSTEM AND RECOMMENDATIONS FOR LABELLING SPECIFICATIONS (ISO 18369-1:2017, CORRECTED VERSION 2017-10-01) |
| BS EN ISO 14730:2014 | Ophthalmic optics. Contact lens care products. Antimicrobial preservative efficacy testing and guidance on determining discard date |
| DIN EN ISO 11980:2013-03 | Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012) |
| BS 7208-20(1999) : 1999 | CONTACT LENSES - OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR THE DETERMINATION OF SHELF-LIFE |
| BS 7208-24(2000) : 2000 | OPHTHALMIC OPTICS - SPECIFICATIONS FOR MATERIAL, OPTICAL AND DIMENSIONAL PROPERTIES OF CONTACT LENSES - PART 2: SINGLE-VISION HYDROGEL CONTACT LENSES |
| BS 7208-16(1998) : 1998 | OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS |
| 08/30138762 DC : DRAFT APR 2008 | BS EN ISO 11980 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS |
| PREN ISO 11978 : DRAFT 2013 | OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - LABELLING (ISO/DIS 11978:2013) |
| EN ISO 18369-2:2017 | Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2017) |
| UNE-EN ISO 11980:2013 | Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012) |
| I.S. EN ISO 13212:2014 | OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR THE DETERMINATION OF SHELF-LIFE (ISO 13212:2014) |
| DIN EN ISO 8320-1:2004-02 | CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - VOCABULARY - PART 1: CONTACT LENSES |
| I.S. EN ISO 14730:2014 | OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - ANTIMICROBIAL PRESERVATIVE EFFICACY TESTING AND GUIDANCE ON DETERMINING DISCARD DATE (ISO 14730:2014) |
| I.S. EN ISO 11980:2012 | OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS (ISO 11980:2012) |
| UNI EN ISO 13212 : 2014 | OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR DETERMINATION OF SHELF-LIFE |
| UNE-EN ISO 18369-2:2013 | Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2012) |
| BS EN ISO 11978:2017 | Ophthalmic optics. Contact lenses and contact lens care products. Labelling |
| 04/30088722 DC : DRAFT APR 2004 | ISO 18369-1 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: TERMINOLOGY |
| BS EN ISO 18369-2:2017 | Ophthalmic optics. Contact lenses Tolerances |
| PD ISO/TS 19979:2014 | Ophthalmic optics. Contact lenses. Hygienic management of multipatient use trial contact lenses |
| ISO 18369-2:2017 | Ophthalmic optics — Contact lenses — Part 2: Tolerances |
| EN ISO 11978:2017 | Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017) |
| 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) |
| BS EN ISO 13212:2014 | Ophthalmic optics. Contact lens care products. Guidelines for determination of shelf-life |
| BS EN ISO 8320-1:2003 | Contact lenses and contact lens care products. Vocabulary Contact lenses |
| EN ISO 18369-3:2017 | Ophthalmic optics - Contact lenses - Part 3: Measurement methods (ISO 18369-3:2017, Corrected version 2017-10-01) |
| EN ISO 13212:2014 | Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2014) |
| UNI EN ISO 14730 : 2015 | OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - ANTIMICROBIAL PRESERVATIVE EFFICACY TESTING AND GUIDANCE ON DETERMINING DISCARD DATE |
| UNI EN ISO 11980 : 2013 | OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS |
| UNE-EN ISO 11978:2018 | Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017) |
| 12/30233857 DC : 0 | BS PREN ISO 18369-2 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 2: TOLERANCES |
| BS 7208-19(2001) : 2001 | CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - VOCABULARY - PART 2: CONTACT LENS CARE PRODUCTS |
| BS EN ISO 18369-1:2017 | Ophthalmic optics. Contact lenses Vocabulary, classification system and recommendations for labelling specifications |
| ISO 18369-1:2017 | Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications |
| ISO 18369-3:2017 | Ophthalmic optics — Contact lenses — Part 3: Measurement methods |
| DIN EN ISO 13212:2014-12 | OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR DETERMINATION OF SHELF-LIFE (ISO 13212:2014) |
| ISO 13212:2014 | Ophthalmic optics — Contact lens care products — Guidelines for determination of shelf-life |
| UNE-EN ISO 14730:2014 | Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014) |
| ISO 8320-1:2003 | Contact lenses and contact lens care products Vocabulary Part 1: Contact lenses |
| UNE-EN ISO 13212:2014 | Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2014) |
| ISO 11980:2012 | Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations |
| ISO 8321-2:2000 | Ophthalmic optics Specifications for material, optical and dimensional properties of contact lenses Part 2: Single-vision hydrogel contact lenses |
| EN ISO 8321-2 : 2000 | OPHTHALMIC OPTICS - SPECIFICATIONS FOR MATERIAL, OPTICAL AND DIMENSIONAL PROPERTIES OF CONTACT LENSES - PART 2: SINGLE-VISION HYDROGEL LENSES |
| EN ISO 14730:2014 | Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014) |
| EN ISO 11980:2012 | Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012) |
| EN ISO 8320-1 : 2003 | CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - VOCABULARY - PART 1: CONTACT LENSES |
| I.S. EN ISO 8321-2:2000 | OPHTHALMIC OPTICS - SPECIFICATIONS FOR MATERIAL, OPTICAL AND DIMENSIONAL PROPERTIES OF CONTACT LENSES - PART 2: SINGLE-VISION HYDROGEL LENSES |
| I.S. EN ISO 8320-1:2003 | CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - VOCABULARY - PART 1: CONTACT LENSES |
| BS EN ISO 18369-3:2017 | Ophthalmic optics. Contact lenses Measurement methods |
| ISO/TS 19979:2014 | Ophthalmic optics Contact lenses Hygienic management of multipatient use trial contact lenses |
| 13/30268148 DC : 0 | BS EN ISO 11978 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - LABELLING |
| 04/30082917 DC : DRAFT APR 2004 | ISO 18369-2 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 2: TOLERANCES |
| PREN ISO 13212 : DRAFT 2013 | OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR DETERMINATION OF SHELF-LIFE (ISO/DIS 13212:2013) |
| I.S. EN ISO 18369-3:2017 | OPHTHALMIC OPTICS - CONTACT LENSES - PART 3: MEASUREMENT METHODS (ISO 18369-3:2017, CORRECTED VERSION 2017-10-01) |
| BS EN ISO 11980:2012 | Ophthalmic optics. Contact lenses and contact lens care products. Guidance for clinical investigations |
| BS EN ISO 8320-2:2001 | Contact lenses and contact lens care products. Vocabulary Contact lens care products |
| ISO 14730:2014 | Ophthalmic optics — Contact lens care products — Antimicrobial preservative efficacy testing and guidance on determining discard date |
| 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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