Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004); German version EN ISO 17664:2004— 23 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.
Electrical apparatus for explosive gas atmospheres - Part 4: Method of test for ignition temperature - First supplement. *Note.-This supplement applies also to the second edition of 1975— 5 стр.
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests— 188 стр.
Medical electrical equipment - Part 1: General requirements for safety; 3. collateral standard: General requirements for radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:1994); German version EN 60601-1-3:1994— 31 стр.
Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering method for an essentially free field over a reflecting plane (ISO/DIS 3744:2006); German version prEN ISO 3744:2006
Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006); German version EN ISO 5356-2:2007— 10 стр.
Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007); German version EN ISO 8185:2007— 62 стр.
Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000); German version EN ISO 9360-1:2000— 18 стр.
Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001); German version EN ISO 9360-2:2002— 12 стр.
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004); German version EN ISO 10651-2:2004— 46 стр.
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004); German version EN ISO 10651-6:2004— 41 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.
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 - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01); German version EN ISO 11137-2:2007— 76 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 - General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000); German version EN ISO 14937:2000— 37 стр.
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems— 254 стр.
Extenders - Specifications and methods of test - Part 1: Introduction and general test methods (ISO 3262-1:2020); German version EN ISO 3262-1:2020— 14 стр.
Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane (ISO 3744:2010)
Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2012 + Amd.1:2019); German version EN ISO 5356-2:2012 + A1:2019— 14 стр.
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd 1:2018) (consolidated version)
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 + Amd.2:2018) (consolidated version)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - AMENDMENT 1 (ISO 11137-2:2013/DAM 1:2021); German and English version EN ISO 11137-2:2015/prA1:2021
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)— 54 стр.
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2020); German and English version prEN ISO 15223-1:2020
Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices— 26 стр.
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO/FDIS 17664-1:2020); German and English version prEN ISO 17664-1:2021— 38 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)
Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003); German version EN ISO 23328-1:2008— 19 стр.
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2020); German version EN ISO 80601-2-70:2020— 83 стр.
Safety devices for gas pressure regulating stations and installations - Gas safety shut-off devices for inlet pressures up to 100 bar; German version EN 14382:2005— 84 стр.
Petroleum, petrochemical and natural gas industries - Non-metallic materials in contact with media related to oil and gas production - Part 1: Thermoplastics (ISO 23936-1:2009); English version EN ISO 23936-1:2009— 36 стр.
Flexible sheets for waterproofing - Plastic and rubber sheets for roof waterproofing - Methods for exposure to liquid chemicals, including water; German version EN 1847:2001— 13 стр.
Flexible sheets for waterproofing - Plastics and rubber sheets for roof waterproofing - Methods for exposure to liquid chemicals, including water; German version EN 1847:2009— 16 стр.
Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015); English version EN ISO 11073-00103:2017— 89 стр.
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2020); German version EN ISO 80601-2-70:2020— 83 стр.
