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ANSI/AAMI/IEC 80601-2-58:2014/A1:2016 (PDF)

Amendment 1 to Medical Electrical Equipment Part 2-58
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$131.00
$131.00

ANSI/AAMI/ISO 10993-9:2009/(R)2014

Biological evaluation of medical devices, Part 9: Framework for identification and quantification of potential degradation products.
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$131.00
$131.00
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ANSI/AAMI/ISO 11138-1:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 1: General requirements
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$243.00
$243.00
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ANSI/AAMI/ISO 11138-2:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes
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ANSI/AAMI/ISO 11138-3:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes
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$114.00
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ANSI/AAMI/ISO 11138-4:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes
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$114.00
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ANSI/AAMI/ISO 11138-5:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
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ANSI/AAMI/ISO 11140-1:2014

Sterilization of health care products - Chemical indicators - Part 1: General requirements.
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ANSI/AAMI/ISO 11658:2012

Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems.
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$114.00
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ANSI/AAMI/ISO 14117:2019

Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
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$282.00
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ANSI/AAMI/ISO 14155:2011

Clinical investigation of medical devices for human subjects.
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ANSI/AAMI/ISO 14708-4:2008/(R)2011

Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps.
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AAMI/ISO TIR16142-1:2016

Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
$137.00
$243.00
$243.00

ANSI/AAMI/ISO 16142-2:2017 (PDF)

Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
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ANSI/AAMI/ISO 25539-2:2012


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$282.00
$282.00

ANSI/AAMI/ISO 25539-2:2012 (PDF)


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ANSI/AAMI/ISO 25539-3:2011/(R)2015

Cardiovascular implants - Endovascular devices - Part 3: Vena Cava Filters.
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$282.00
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ANSI/AAMI/ISO 27186:2010

Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements.
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$282.00
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ANSI/AAMI/ISO 5840-3:2013

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques.
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$282.00
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ANSI/AAMI/ISO 80369-5: 2016

Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 5: Connectors for Limb Cuff Inflation Applications
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$200.00
$200.00