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ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Consolidated Text)

Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
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ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Redline Version)

Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
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ANSI/AAMI/IEC 60601-2-47:2012/(R)2016

Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
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ANSI/AAMI/IEC 80601-2-30:2018

Medical electrical equipment—Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
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ANSI/AAMI/IEC 80601-2-58:2014

Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery
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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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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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ANSI/AAMI/ISO 11138-1:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 1: General requirements
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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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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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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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ANSI/AAMI/ISO 12417-1:2015 (PDF)

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
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ANSI/AAMI/ISO 14117:2012

Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices.
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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
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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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