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 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.
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 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); German version EN ISO 10993-17:2009— 38 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012— 86 стр.
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011— 70 стр.
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003); German version EN ISO 15197:2003, text German and English— 84 стр.
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003); German version EN ISO 17511:2003— 35 стр.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011— 60 стр.
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003); German version EN ISO 18153:2003— 17 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.
District heating pipes - Bonded single and twin pipe systems for buried hot water networks - Surveillance systems; German version EN 14419:2019— 28 стр.
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk; German version EN 12442-1:2000— 16 стр.
Quality management and quality assurance standards - Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software (ISO 9000-3:1997); Bilingual version EN ISO 9000-3:1997— 43 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
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO/DIS 17511:2019); German and English version prEN ISO 17511:2019
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
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)
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2009— 103 стр.
Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases; German version EN 15908:2010— 19 стр.
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014— 69 стр.
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2003+A2:2009— 60 стр.
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version EN ISO 20857:2013— 72 стр.
Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015); German version EN ISO 23747:2015— 40 стр.
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015— 15 стр.
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2011— 15 стр.
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013— 15 стр.
Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007); German version EN ISO 23747:2009— 36 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.
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.
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 23908:2011— 19 стр.
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013— 15 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.
Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment; German version EN 1865-1:2010+A1:2015— 34 стр.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003— 10 стр.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015— 19 стр.
Patient handling equipment used in road ambulances - Part 1: Specification for general stretcher systems and patient handling equipment; German version EN 1865-1:2010— 35 стр.
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances; German version EN 13718-1:2008— 20 стр.
Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases (ISO/DIS 5359:2012), German version prEN ISO 5359:2012— 38 стр.
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012); German version FprEN ISO 7199:2014— 18 стр.
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005); German version EN ISO 10524-3:2006— 45 стр.
Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems; (ISO 8835-3:2007 + Amd. 1:2010); German version EN ISO 8835-3:2009 + A1:2010— 34 стр.
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version EN ISO 13408-7:2015— 38 стр.
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008 + Amd 1:2013); German version EN ISO 13408-1:2011 + A1:2013— 64 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2015— 92 стр.
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)— 71 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2012); German version EN ISO 11608-1:2012— 49 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2013— 86 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014); German version EN ISO 11608-1:2015— 52 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012); German version EN ISO 11137-2:2012— 86 стр.
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013); German version EN ISO 13408-1:2015— 70 стр.
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011); German version EN ISO 11979-8:2009 + A1:2011— 13 стр.
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version FprEN ISO 13408-7:2015— 38 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/FDIS 11137-2:2012); German version FprEN ISO 11137-2:2012— 86 стр.
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006 + Amd 1:2014); German version EN ISO 15883-1:2009 + A1:2014— 90 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2015— 23 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2011— 21 стр.
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15); German version EN ISO 16061:2009— 27 стр.
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011); German version EN ISO 15378:2011— 80 стр.
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2009— 103 стр.
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2013— 59 стр.
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003); German version EN ISO 15197:2003, text German and English— 84 стр.
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013), German version EN ISO 15197:2013— 59 стр.
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2015— 63 стр.
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015); German version EN ISO 80601-2-72:2015— 117 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.
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 10651-2:2009— 46 стр.
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015); German version EN ISO 5840-2:2015— 71 стр.
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007 + Amd 1:2010 + Amd 2:2010); German version EN ISO 7396-1:2007 + A1:2010 + A2:2010— 159 стр.
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment (IEC 62570:2014); German version EN 62570:2015— 29 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012— 86 стр.
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016); German version EN ISO 9626:2016— 35 стр.
