Association for the Advancement of Medical Instrumentation (AAMI)

Association for the Advancement of Medical Instrumentation (AAMI)
AAMI (Association for the Advancement of Medical Instrumentation) is a non-profit organization that accredits manufacturers and suppliers of medical devices. Its accreditation program assesses compliance with quality and performance standards for medical devices. AAMI also provides guidelines and recommendations for the design, testing, and labeling of medical devices. By using AAMI-accredited devices, healthcare providers can ensure their patients receive safe and effective care.
ANSI/AAMI/ISO 10993-7:2008/(R)2012

ANSI/AAMI/ISO 10993-7:2008/(R)2012

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Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals

€292.00

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ANSI/AAMI/ISO 14708-4:2008/(R)2011

ANSI/AAMI/ISO 14708-4:2008/(R)2011

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Implants for surgery—Active implantable medical devices—Part 4: Implantable infusion pumps

€251.00

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ANSI/AAMI/ISO 15882:2008/(R)2025

ANSI/AAMI/ISO 15882:2008/(R)2025

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Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of results

€221.00

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ANSI/AAMI/ISO 11140-3:2007/(R)2025

ANSI/AAMI/ISO 11140-3:2007/(R)2025

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Sterilization of health care products—Chemical indicators—Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test

€178.00

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ANSI/AAMI/ISO 11140-4:2007/(R)2025

ANSI/AAMI/ISO 11140-4:2007/(R)2025

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Sterilization of health care products—Chemical indicators—Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration

€221.00

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ANSI/AAMI/ISO 11140-5:2007/(R)2025

ANSI/AAMI/ISO 11140-5:2007/(R)2025

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Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs

€178.00

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ANSI/AAMI/ISO 22442-3:2007/(R)2016

ANSI/AAMI/ISO 22442-3:2007/(R)2016

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Medical devices utilizing animal tissues and their derivatives—Part 3: Validation of the elimination and/or inactivation of viruses and transimissible spongiform encephalopathy (TSE) agents

€178.00

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ANSI/AAMI/ISO 81060-1:2007/(R)2013

ANSI/AAMI/ISO 81060-1:2007/(R)2013

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Non invasive sphygmomanometers—Part 1: Requirements and test methods for nonautomated measurement type

€251.00

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ANSI/AAMI/IEC 62304:2006 & A1:2016 (Consolidated Text)

ANSI/AAMI/IEC 62304:2006 & A1:2016 (Consolidated Text)

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Medical device software—Software life cycle processes

€1,476.00

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ANSI/AAMI/ISO 10993-2:2006/(R)2014

ANSI/AAMI/ISO 10993-2:2006/(R)2014

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Biological evaluation of medical devices—Part 2: Animal welfare requirements

€144.00

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ANSI/AAMI BE83:2006/(R)2011

ANSI/AAMI BE83:2006/(R)2011

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Biological evaluation of medical devices—Part 18: Chemical characterization of materials

€144.00

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ANSI/AAMI/IEC 62304:2006 & A1:2016 (Redline)

ANSI/AAMI/IEC 62304:2006 & A1:2016 (Redline)

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Medical device software—Software life cycle processes

€1,476.00

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ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019  (Consolidated Text)

ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019 (Consolidated Text)

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Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

€268.00

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ANSI/AAMI/ISO 13408-3:2006/(R)2015

ANSI/AAMI/ISO 13408-3:2006/(R)2015

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Aseptic processing of health care products—Part 3: Lyophilization

€144.00

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ANSI/AAMI/ISO 13408-5:2006/(R)2015

ANSI/AAMI/ISO 13408-5:2006/(R)2015

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Aseptic processing of health care products—Part 5: Sterilization in place

€144.00

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