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)— 98 стр.
Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003); Trilingual version EN ISO 10012:2003— 56 стр.
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.
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version EN ISO 10993-7:2008— 108 стр.
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006); German version EN ISO 11138-1:2006— 48 стр.
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006); German version EN ISO 11138-2:2009— 14 стр.
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO/DIS 11140-1:2012); German version prEN ISO 11140-1:2012
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); German version EN ISO 11607-1:2009— 34 стр.
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006); German version EN ISO 11607-2:2006— 18 стр.
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006); German version EN ISO 11737-1:2006 + AC:2009— 48 стр.
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); German version EN ISO 11737-2:2009— 28 стр.
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009); German version EN ISO 14161:2009— 79 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 (ISO 14937:2009)— 54 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.
Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006); German version EN ISO 15883-2:2009— 20 стр.
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008); German version EN ISO 15883-4:2009— 67 стр.
Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011); German version EN ISO 15883-6:2011— 15 стр.
Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO/DIS 15883-7:2014); German version prEN ISO 15883-7:2014
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.
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007); German version EN ISO 22442-1:2007— 36 стр.
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007); German version EN ISO 22442-2:2007— 23 стр.
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007— 31 стр.
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009); German version CEN ISO/TS 17665-2:2009
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.
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials— 63 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.
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2020); German and English version prEN ISO 10993-2:2020
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014— 48 стр.
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1 (ISO 10993-7:2008/DAM 1:2018); German and English version EN ISO 10993-7:2008/prA1:2018
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO/DIS 10993-9:2018); German and English version prEN ISO 10993-9:2018
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO/DIS 10993-10:2020); German and English version prEN ISO 10993-10:2020
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO/DIS 10993-12:2019); German and English version prEN ISO 10993-12:2019
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010— 26 стр.
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO/DIS 10993-15:2018); German and English version prEN ISO 10993-15:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017— 26 стр.
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017); German version EN ISO 11138-1:2017— 52 стр.
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017); German version EN ISO 11138-2:2017— 15 стр.
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014); German version EN ISO 11140-1:2014— 43 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.
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/DAM 1:2019); German and English version EN ISO 11737-1:2018/prA1:2019
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019); German version EN ISO 11737-2:2020— 43 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO/DIS 15883-1:2020); German and English version prEN ISO 15883-1:2020
Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)
Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011); German version EN ISO 15883-6:2015— 22 стр.
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014); German version CEN ISO/TS 16775:2014
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.
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO/DIS 22442-1:2018); German and English version prEN ISO 22442-1:2018
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO/DIS 22442-2:2018); German and English version prEN ISO 22442-2:2018
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
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) (includes Amendment :2019)— 115 стр.
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2012); German version prEN ISO 11135:2012
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 - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008); German version CEN ISO/TS 11135-2:2008, Corrigendum to DIN ISO/TS 11135-2:2008-11; German version CEN ISO/TS 11135-2:2008/AC:2009
Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015); German version EN ISO 8536-8:2015— 23 стр.
Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015); German version EN ISO 8536-9:2015— 21 стр.
Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015); German version EN ISO 8536-10:2015— 18 стр.
Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015); German version EN ISO 8536-11:2015— 18 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 - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014); German version EN ISO 11140-1:2014— 43 стр.
Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015); German version EN ISO 1135-5:2015— 34 стр.
Sterilization - Low temperature sterilizers - Part 7: Requirements for the installation and operation of ethylene oxide sterilizers and their supply sources— 29 стр.
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016); German version EN ISO 7198:2017— 76 стр.
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017); German version EN ISO 11138-1:2017— 52 стр.
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017); German version EN ISO 11138-2:2017— 15 стр.
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015); German version EN ISO 15378:2015— 85 стр.
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP) (ISO/DIS 15378:2016); German and English version prEN ISO 15378:2016— 85 стр.
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018); German version EN ISO 8637-2:2018— 30 стр.
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018); German version EN ISO 11737-1:2018— 75 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) (includes Amendment :2019)— 115 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.
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015); German version EN ISO 16061:2015— 28 стр.
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017); German version EN ISO 17664:2017— 36 стр.
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018); German version EN ISO 11737-1:2018— 76 стр.
