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 of noise sources using sound pressure - Engineering method in an essentially free field over a reflecting plane (ISO 3744:1994); English version FprEN ISO 3744:2009, Amendment 1
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.
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.
Anodizing of aluminium and its alloys - Assessment of resistance of anodic oxidation coatings to cracking by deformation (ISO/DIS 3211:2009); German version prEN ISO 3211: 2009
Acoustics - Declaration and verification of noise emission values of machinery and equipment (ISO 4871:1996); English version FprEN ISO 4871:2009, Amendment 1
Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007); German version EN ISO 8185:2009— 64 стр.
Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008); German version EN ISO 9170-1:2008— 33 стр.
Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002); German version EN ISO 10651-4:2002, Corrigenda to DIN EN ISO 10651-4:2002-11; German version EN ISO 10651-4:2002/AC:2006— 2 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); Corrigendum to DIN EN ISO 14937:2001-05; German version EN ISO 14937:2000/AC:2005— 2 стр.
Medical devices - Application of risk management to medical devices (ISO 14971:2007); German version EN ISO 14971:2007, Corrigenda to DIN EN ISO 14971:2007-07— 2 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. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices— 26 стр.
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.
