09/30207531 DC : 0
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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Superseded date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
Superseded by
Language(s)
English
Publisher
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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Superseded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 |
| 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 |
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