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AAMI RT2:2017 (PDF)

Radiation therapy readiness check
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AAMI TIR38:2014

Medical device safety assurance case guidance
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$125.00
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$222.00
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AAMI/ISO TIR19218-1:2011 & A1:2013

Medical devices hierarchal coding structure for adverse events. Part 1: Event type codes. (Includes Amendment 1)
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$148.00
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AAMI/ISO TIR19218-1:2011/A1:2013

Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes, Amendment 1.
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AAMI/ISO TIR24971:2013/(R)2016

Medical devices - Guidance on the application of ISO 14971.
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ANSI/AAMI EC12:2000/(R)2015

Disposable ECG electrodes
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ANSI/AAMI EQ56:2013

Recommended practice for a medical equipment management program
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ANSI/AAMI EQ89:2015

Guidance for the use of medical equipment maintenance strategies and procedures
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ANSI/AAMI/ ISO 25539-3: 2011/(R)2015 (PDF)

Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters
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ANSI/AAMI/ISO 14971:2007/(R)2016

Medical devices - Application of risk management to medical devices.
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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 80369-1:2010

Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements.
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ANSI/AAMI/ISO 80369-20:2015

Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods.
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$118.00
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ANSI/AAMI/ISO 80369-3:2016 (PDF)

Small-bore connectors for liquids and gases in healthcare applications. Part 3: connectors for enteral applications.
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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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$104.00
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$183.00
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ANSI/AAMI/ISO 80369-6:2016

Small-bore connectors for liquids and gases in healthcare applications. Part 6: Connectors for neuraxial applications.
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$125.00
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$222.00
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ANSI/AAMI/ISO 8637:2010/(R)2015 (PDF)

Cardiovascular implants and extracorporeal systems — Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
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ANSI/AAMI/ISO 8638/(R)2015 (PDF)

Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
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$148.00
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AAMI/ISO TIR19218-2:2012

Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes.
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$119.00
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