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EN 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 (ISO 11737-2:2009) |
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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 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 (ISO 14937:2009) |
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EN 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 |
|
ISO 11737-2:2009
|
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 ISO 10993-17:2009
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Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
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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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EN ISO 14161:2009
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Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009) |
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EN 867-5:2001
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Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S |
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EN 14180:2014
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Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
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EN ISO 11138-1:2017
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Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017) |
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ISO/TS 11139:2006
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Sterilization of health care products Vocabulary |
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AAMI RD47 : 2008
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REPROCESSING OF HEMODIALYZERS |
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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 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
|
ISO 10012:2003
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Measurement management systems — Requirements for measurement processes and measuring equipment |
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ISO 9000:2015
|
Quality management systems — Fundamentals and vocabulary |
|
ISO 11138-1:2017
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Sterilization of health care products — Biological indicators — Part 1: General requirements |
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CEN Guide 4:2008
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GUIDE FOR ADDRESSING ENVIRONMENTAL ISSUES IN PRODUCT STANDARDS |
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EN ISO 10012:2003
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Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003) |
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ISO 14161:2009
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Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
|
ISO 11138-5:2017
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Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
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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 ISO 10993-1:2009/AC:2010
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010) |
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EN ISO 11138-5:2017
|
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017) |
|
EN ISO 9000:2015
|
Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
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1997/23/EC : 1997
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DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 29 MAY 1997 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING PRESSURE EQUIPMENT |