Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO/DIS 14534:2009); German version prEN 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 - 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.
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.
Sterilization of medical devices - Validation and routine control of sterilization by irradiation (includes Corrigendum 1:1999 (A1:1999) and Amendment A2:2000); German version EN 552:1994 + Corrigendum 1:1999 (A1:1999) + Amendment A2:2000— 29 стр.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1:2001/AC:2006— 2 стр.
Contact lenses and contact lens care products - Vocabulary - Part 2: Contact lens care products (ISO 8320-2:2001); German version EN ISO 8320-2:2001— 9 стр.
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
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 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Ophthalmic optics - Specifications for material, optical and dimensional properties of contact lenses - Part 1: Rigid corneal and scleral contact lenses (ISO 8321-1:2002); German version EN ISO 8321-1:2002— 18 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)
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements; German version EN 1174-1:1996— 8 стр.
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance; German version EN 1174-2:1996— 13 стр.
Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniques; German version EN 1174-3:1996— 9 стр.
Glass in building - Glazing and airborne sound insulation - Product descriptions and determination of properties; German version EN 12758:2011— 23 стр.
District heating pipes - Preinsulated bonded pipe systems for directly buried hot water networks - Surveillance systems; German and English version EN 14419:2009— 51 стр.
Optics and optical instruments - Contact lenses - Determination of the spectral and luminous transmittance (ISO 8599:1994); German version EN ISO 8599:1996— 5 стр.
Ophthalmic optics - Specifications for material, optical and dimensional properties of contact lenses - Part 2: Single-vision hydrogel lenses (ISO 8321-2:2000); German version EN ISO 8321-2:2000— 7 стр.
Quality management systems - Requirements (ISO 9001:2008); Trilingual version EN ISO 9001:2008, Corrigendum to DIN EN ISO 9001:2008-12; Trilingual version EN ISO 9001:2008/AC:2009— 20 стр.
Contact lenses - Determination of back vertex power - Part 1: Method using focimeter with manual focusing (ISO 9337-1:1999); German version EN ISO 9337-1:2000— 11 стр.
Optics and optical instruments - Contact lenses; Determination of the thickness - Part 1: Rigid contact lenses (ISO 9339-1:1996); German version EN ISO 9339-1:1998— 5 стр.
Optics and optical instruments - Contact lenses; determination of thickness - Part 2: Hydrogel contact lenses (ISO 9339-2:1998); German version EN ISO 9339-2:1998— 5 стр.
Optics and optical instruments - Contact lenses - Determination of inclusions and surface imperfections for rigid contact lenses (ISO 9341:1996); German version EN ISO 9341:1998— 4 стр.
Optics and optical instruments - Contact lenses - Determination of cytotoxicity of contact lens material - Part 1: Agar overlay test and growth inhibition test (ISO 9363-1:1994)
Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study using rabbit eyes (ISO 9394:1998)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO/DIS 10993-1:2006); German version prEN ISO 10993-1:2007
Optic and optical instruments - Contact lenses - Part 1: Determination of oxygen permeability and transmissibility by the FATT method (ISO 9913-1:1996); German version EN ISO 9913-1:1998— 11 стр.
Optics and optical instruments - Contact lenses - Part 2: Determination of oxygen permeability and transmissibility by the coulometric method (ISO 9913-2:2000); German version EN ISO 9913-2:2000— 9 стр.
Optics and optical instruments - Contact lenses - Determination of refractive index of contact lens materials (ISO 9914:1995); German version EN ISO 9914:1996— 5 стр.
Optics and optical instruments - Contact lenses - Method for determining the extractable substances (ISO 10340:1995); German version EN ISO 10340:1996— 6 стр.
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009 + Cor 1:2010) (consolidated version)
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.
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
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 12: Sample preparation and reference materials (ISO/DIS 10993-12:2010); German version prEN ISO 10993-12:2010
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
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 - 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 - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)
Ophthalmic optics - Contact lenses - Classification of contact lenses and contact lens materials (ISO 11539:1999); German version EN ISO 11539:1999— 5 стр.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
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)
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)
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 - 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 lens care products - Guidelines for determination of shelf-life (ISO/FDIS 13212:2011); German version FprEN ISO 13212:2011— 14 стр.
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (Revision of EN 46002:1996) (Identical to ISO 13488:1996); German version EN ISO 13488:2000— 13 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)
Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses (ISO 14729:2001); German version EN ISO 14729:2001— 20 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
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2011— 21 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002); German version EN ISO 14534:2002— 16 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.
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2009); German version EN ISO 11980:2009— 36 стр.
Opthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:1997); German version EN ISO 11980:1997— 15 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses (ISO/FDIS 11981:2009); German version FprEN ISO 11981:2009— 10 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.
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.
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.
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.
