Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2011— 21 стр.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO/DIS 10993-12:2010); German version prEN ISO 10993-12:2010
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2010— 83 стр.
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)— 19 стр.
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003); German version EN ISO 10993-3:2009— 27 стр.
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009— 35 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:1998); German version EN ISO 9394:1998— 9 стр.
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 11140-3:2007, including Cor 1:2007)
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014); German version EN ISO 11140-1:2014— 43 стр.
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006); German version EN ISO 11138-5:2006, Corrigenda to DIN EN ISO 11138-5:2006-09— 2 стр.
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006); German version EN ISO 11138-1:2006, Corrigendum to DIN EN ISO 11138-1:2006-09— 5 стр.
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO/DIS 11137-3:2015); German and English version prEN ISO 11137-3:2015
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2013— 86 стр.
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 + Amd 1:2013); German version EN ISO 11137-1:2006 + A1:2013— 53 стр.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012— 33 стр.
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014— 48 стр.
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013— 83 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012); German version EN ISO 9394:2012— 19 стр.
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); German version EN 1040:2005— 42 стр.
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German version EN 868-8:2009— 21 стр.
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German and English version prEN 868-7:2015
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German and English version prEN 868-6:2015
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
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; German and English version prEN 868-3:2015
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German and English version prEN 868-2:2015
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2: Requirements for aseptically processed medical devices; German version prEN 556-2:2014
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices (consolidated version)
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007— 31 стр.
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007); German version EN ISO 22442-2:2007— 23 стр.
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007); German version EN ISO 22442-1:2007— 36 стр.
Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006); German version EN ISO 18472:2006— 34 стр.
Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials (ISO 18369-4:2006); German version EN ISO 18369-4:2006— 39 стр.
Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications (ISO 18369-1:2006 + Amd.1:2009); German version EN ISO 18369-1:2006 + A1:2009— 64 стр.
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); German version EN ISO 17665-1:2006— 51 стр.
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2009); German version prEN ISO 15223-1:2009
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2009— 103 стр.
Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2000); German version EN ISO 14730:2000— 27 стр.
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— 32 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009— 75 стр.
Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO/FDIS 13212:2011); German version FprEN ISO 13212:2011— 14 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release (ISO 11986:2010); German version EN ISO 11986:2010— 12 стр.
Opthalmic optics - Contact lenses - Ageing by exposure to UV and visible radiation (in vitro method) (ISO 11985:1997); German version EN ISO 11985:1997— 7 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses (ISO 11981:2009); German version EN ISO 11981:2009— 10 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2009); German version EN ISO 11980:2009— 36 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Information supplied by the manufacturer (ISO 11978:2000); German version EN ISO 11978:2000— 6 стр.
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009); German version EN ISO 11737-2:2009— 28 стр.
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006); German version EN ISO 11737-1:2006 + AC:2009— 48 стр.
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006); German version EN ISO 11607-2:2006— 18 стр.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); German version EN ISO 11607-1:2009— 34 стр.
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); German version EN ISO 11140-4:2007— 43 стр.
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 11140-3:2007, including Cor 1:2007); German version EN ISO 11140-3:2009— 30 стр.
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005); German version EN ISO 11140-1:2009— 39 стр.
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006); German version EN ISO 11138-5:2006— 13 стр.
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2006); German version EN ISO 11138-4:2006— 16 стр.
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-2:2006); German version EN ISO 11138-3:2009— 16 стр.
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006); German version EN ISO 11138-2:2009— 14 стр.
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006); German version EN ISO 11138-1:2006— 48 стр.
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006); German version EN ISO 11137-3:2006— 25 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/DIS 11137-2:2010); German version prEN ISO 11137-2:2010
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); German version EN ISO 11137-1:2006— 49 стр.
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007); German version EN ISO 11135-1:2007— 52 стр.
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO/FDIS 22442-2:2015); German and English version FprEN ISO 22442-2:2015
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO/FDIS 22442-1:2015); German and English version FprEN ISO 22442-1:2015
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)
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2015); German and English version prEN ISO 15223-1:2015
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012— 112 стр.
Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014); German version EN ISO 14730:2014— 31 стр.
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) (consolidated version)
Reaction to fire tests. Determination of fire parameters of materials, products and assemblies using an intermediate scale heat release calorimeter (ICAL)— 52 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2015); German and English version prEN ISO 13485:2015
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012); German version EN ISO 11980:2012— 33 стр.
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006 + Cor 1:2007) (consolidated version)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006 + Amd 1:2014); German version EN ISO 11607-2:2006 + A1:2014— 21 стр.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1:2014); German version EN ISO 11607-1:2009 + A1:2014— 45 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2015— 23 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002); German version EN ISO 14534:2009— 20 стр.
Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014); German version EN ISO 14730:2014— 31 стр.
Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2011); German version EN ISO 13212:2011— 14 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Information supplied by the manufacturer (ISO 11978:2000); German version EN ISO 11978:2000— 6 стр.
Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2014); German version EN ISO 13212:2014— 16 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012); German version EN ISO 11980:2012— 33 стр.
Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO/FDIS 13212:2011); German version FprEN ISO 13212:2011— 14 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2015— 23 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002); German version EN ISO 14534:2009— 20 стр.
Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2000); German version EN ISO 14730:2000— 27 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO/DIS 14534:2009); German version prEN ISO 14534:2009— 20 стр.
