Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices— 26 стр.
Carbonaceous materials used in the production of aluminium. Pitch for electrodes. Determination of the softening point (Mettler softening point method)— 16 стр.
Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices— 48 стр.
Sterilization of health care products -- Radiation -- Part 1: Requirements For development, validation and routine control of a sterilization process for medical devices— 44 стр.
Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products -- Technical Corrigendum 1— 1 стр.
Sterilization of health care products -- Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives -- Requirements for characterization, development, validation and routine control of a sterilization process for medical devices— 42 стр.
Cleanrooms and associated controlled environments. Part 2. Specification for testing and monitoring to prove continued compliance with ISO 14644-1— 14 стр.
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— 46 стр.
Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Symbol development, selection and validation— 28 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— 48 стр.
Graphical symbols for use on equipment - 12-month subscription to regularly updated online database comprising all graphical symbols published in IEC 60417— 0 стр.
Safety requirements for electrical equipment for measurement, control, and laboratory use. Conformity verification report for IEC 61010-2-061, particular requirements for laboratory atomic spectrometers with thermal atomization and ionization— 66 стр.
Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneoulsy breathing humans (ISO 23747:2007); German version EN ISO 23747:2007— 36 стр.
Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009); German version EN ISO 26782:2009— 36 стр.
Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009 + Cor. 1:2009) (includes Corrigendum AC:2009)— 36 стр.
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007); German version EN ISO 81060-1:2012— 50 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.
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 10651-6:2009— 43 стр.
Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007); German version EN ISO 8185:2007— 62 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.
Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards— 60 стр.
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009); German version EN ISO 80601-2-56:2012— 63 стр.
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15); German version EN ISO 80369-6:2016— 65 стр.
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016); German version EN ISO 80369-6:2016— 65 стр.
Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014); German version EN ISO 80601-2-69:2014— 56 стр.
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016); German version EN ISO 7396-1:2016— 206 стр.
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016 + Amd 1:2017); German version EN ISO 7396-1:2016 + A1:2019— 209 стр.