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.
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 11607-1:2017— 49 стр.
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 11607-2:2017— 24 стр.
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.
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03); German version EN ISO 15223-1:2016, with CD-ROM— 47 стр.
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011); German version EN ISO 23908:2013— 20 стр.
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01); German version EN ISO 80369-7:2017— 65 стр.
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015); German version EN ISO 80369-20:2015— 36 стр.
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020); German version EN ISO 10993-18:2020— 96 стр.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); German version EN ISO 11607-1:2020— 60 стр.
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020— 23 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 -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation— 24 стр.
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011)
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO/DIS 80369-7:2019); German and English version prEN ISO 80369-7:2019
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected version 2019-08); German version EN ISO 7886-1:2018— 43 стр.
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:1993, including Technical Corrigendum 1:1995); German version EN ISO 7886-1:1996— 20 стр.
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:1993, including Technical Corrigendum 1:1995); German version EN ISO 7886-1:1996— 20 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 1: General requirements (ISO 80369-1:2018); German version EN ISO 80369-1:2018— 49 стр.
Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014 + Amd 1:2018); German version EN ISO 11070:2014 + A1:2018— 38 стр.
Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014 + Amd 1:2018); German version EN ISO 11070:2014 + A1:2018— 38 стр.
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected version 2019-08); German version EN ISO 7886-1:2018— 43 стр.
