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AAMI TIR32:2004/(R)2016

Medical device software risk management
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$119.00
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AAMI TIR32:2004/(R)2016 (PDF Format)

Medical device software risk management
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$119.00
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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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ANSI/ AAMI/ISO 8637:2010/ (R)2015 (PDF Version)

Cardiovascular implants and extracorporeal systems — Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
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$104.00
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ANSI/AAMI EQ56:2013

Recommended practice for a medical equipment management program
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$104.00
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$183.00
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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 Version)

Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters
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$146.00
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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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$104.00
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$183.00
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ANSI/AAMI/ISO 14971:2007/(R)2016

Medical devices - Application of risk management to medical devices.
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$146.00
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$258.00
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ANSI/AAMI/ISO 15223-2:2010

Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation
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ANSI/AAMI/ISO 16142-1:2016

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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$125.00
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$222.00
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ANSI/AAMI/ISO 16142-1:2016 (PDF Format)

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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$125.00
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$209.00
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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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$208.00
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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 80369-6:2016

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 80369-6:2016 (PDF Format)

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 8638/(R)2015 (PDF)

Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
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$84.00
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$148.00
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ANSI/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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