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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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AS/NZS 4187:2014
|
Reprocessing of reusable medical devices in health service organisations |
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AAMI ST41 : 2008
|
ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS |
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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 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 11737-1:2006
|
Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
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ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
|
ISO/TS 16775:2014
|
Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
|
ISO 14937:2009
|
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 22442-1:2015
|
Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
|
AAMI TIR28 : 2016
|
PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION |
|
ISO 11138-2:2017
|
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
|
AAMI TIR15 : 2016
|
PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION |
|
ISO/IEC Guide 99:2007
|
International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
|
ISO 11140-1:2014
|
Sterilization of health care products Chemical indicators Part 1: General requirements |
|
ISO/TS 11139:2006
|
Sterilization of health care products Vocabulary |
|
ISO 10993-7:2008
|
Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
|
ISO 14001:2015
|
Environmental management systems — Requirements with guidance for use |
|
ISO 10012:2003
|
Measurement management systems — Requirements for measurement processes and measuring equipment |
|
ISO 9001:2015
|
Quality management systems — Requirements |
|
ISO 22442-2:2015
|
Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
|
ISO 9000:2015
|
Quality management systems — Fundamentals and vocabulary |
|
ISO 11138-1:2017
|
Sterilization of health care products — Biological indicators — Part 1: General requirements |
|
ISO 22442-3:2007
|
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 14971:2007
|
Medical devices Application of risk management to medical devices |
|
ISO 11607-1:2006
|
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
|
ISO/IEC 90003:2014
|
Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
|
ISO 14161:2009
|
Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
|
IEC 61010-1:2010+AMD1:2016 CSV
|
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
|
ISO 14040:2006
|
Environmental management Life cycle assessment Principles and framework |
|
ISO 17664:2017
|
Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |