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ANSI/AAMI/ISO 14971:2007/(R)2016

Medical devices - Application of risk management to medical devices.
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$150.00
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$266.00
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AAMI EQ93:2018(PS) (PDF)

Medical equipment management--Vocabulary used in medical equipment programs
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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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$129.00
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AAMI TIR57:2016

Principles for Medical Device Security - Risk Management
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$158.00
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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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$87.00
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$152.00
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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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$66.00
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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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$107.00
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$188.00
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ANSI/AAMI EQ89:2015

Guidance for the use of medical equipment maintenance strategies and procedures
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$69.00
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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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$129.00
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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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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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$122.00
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$214.00
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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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$129.00
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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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$107.00
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$188.00
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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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$129.00
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$229.00
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