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Superseded

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BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS

Available format(s)

Hardcopy , PDF

Superseded date

30-04-2011

Language(s)

English

Publisher

British Standards Institution

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
   10.1 Contact lenses
        10.1.1 Lenses delivered sterile
        10.1.2 Lenses delivered non-sterile
        10.1.3 Trial lenses
   10.2 Contact lens care products
   10.3 Other accessories for contact lenses
11 Packaging
12 Shelf-life and discard date
13 Labelling and information supplied by the
   manufacturer
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EC
         Directive 93/42/EEC
Bibliography

BS EN ISO 14534

Committee	CH/172/9
DocumentType	Draft
Pages	19
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 14534:2015

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 14155-2:2003	Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
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
ISO 14155-1:2003	Clinical investigation of medical devices for human subjects Part 1: General requirements
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/TS 13409:2002	Sterilization of health care products Radiation sterilization Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
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 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 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