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IEC 61010-2-040:2015
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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 |
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EN 12442-3 : 2000
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ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS |
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ISO 15883-1:2006
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Washer-disinfectors Part 1: General requirements, terms and definitions and tests |
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ISO 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
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ISO 11138-3:2017
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Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
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ISO 15882:2008
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Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
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EN 285:2015
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Sterilization - Steam sterilizers - Large sterilizers |
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ISO 11737-2:2009
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Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
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ISO 11737-1:2006
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Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
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EN 868-5:2009
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Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods |
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EN 868-4:2017
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Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods |
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
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ISO 14937:2009
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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 |
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ISO 11140-3:2007
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Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test |
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EN 868-2:2017
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Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods |
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EN 868-3:2017
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Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods |
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ISO 11140-1:2014
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Sterilization of health care products Chemical indicators Part 1: General requirements |
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ISO 11140-4:2007
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Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration |
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ISO 9004:2009
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Managing for the sustained success of an organization A quality management approach |
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ISO 15883-4:2008
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Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes |
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ISO 10993-17:2002
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Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
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ISO 14001:2015
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Environmental management systems — Requirements with guidance for use |
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ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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ISO 10012:2003
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Measurement management systems — Requirements for measurement processes and measuring equipment |
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ISO 9001:2015
|
Quality management systems — Requirements |
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ISO 9000:2015
|
Quality management systems — Fundamentals and vocabulary |
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ISO 11140-5:2007
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Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests |
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EN 12442-1 : 2000
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ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
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ISO 11138-1:2017
|
Sterilization of health care products — Biological indicators — Part 1: General requirements |
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ISO 14971:2007
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Medical devices Application of risk management to medical devices |
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ISO 11607-1:2006
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Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
|
ISO 14161:2009
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Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
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ISO 14040:2006
|
Environmental management Life cycle assessment Principles and framework |
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ISO 15883-2:2006
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Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. |
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ISO 17664:2017
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Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
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EN 13060:2014
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Small steam sterilizers |
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EN 12442-2 : 2000
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ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
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ISO 9000-3:1997
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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 |