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Dialysis Standards Collection

The 2015 collection consists of 11 AAMI Hemodialysis standards, six of which were published in 2014
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$357.00
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$541.00
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AAMI TIR14:2016

Contract sterilization using ethylene oxide
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$67.00
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$119.00
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AAMI TIR34:2014

Water for the reprocessing of medical devices
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$131.00
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$222.00
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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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AAMI TIR50:2014

Post-market surveillance of user error management
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$104.00
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$183.00
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AAMI TIR51:2014

Human factors engineering – Guidance for contextual inquiry
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$67.00
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$119.00
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AAMI TIR52:2014

Environmental monitoring for terminally sterilized healthcare products.
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$59.00
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$104.00
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AAMI TIR55:2014

Human factors engineering for processing medical devices
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$84.00
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$148.00
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AAMI TIR58:2014

Water testing methodologies
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$118.00
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$208.00
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AAMI TIR60:2014

Common mode rejection in ECG monitoring
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$67.00
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$119.00
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AAMI TIR61:2014

Generating reports for human factors design validation results for external cardiac defibrillators
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$67.00
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$119.00
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AAMI TIR62:2014

Generating reports for the purpose of submitting defibrillation waveform data for evaluation
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$59.00
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$104.00
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AAMI TIR63:2014

Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection.
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$59.00
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$104.00
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AAMI TIR74:2016

Change summary for ISO 11135:2014, Sterilization of health care products—Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices.
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$67.00
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$119.00
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AAMI TIR74:2016 (PDF Format)

Change summary for ISO 11135:2014, Sterilization of health care products—Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices.
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$67.00
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$119.00
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ANSI/AAMI/IEC TIR80001-2-5:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance for distributed alarm systems
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$104.00
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$183.00
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ANSI/AAMI/IEC TIR80001-2-6:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements
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$67.00
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$119.00
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ANSI/AAMI/IEC TIR80001-2-7:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-7: Application guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
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$146.00
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$258.00
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ANSI/AAMI/ISO TIR16775:2014

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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$146.00
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$258.00
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ANSI/AAMI/ISO TIR17665-3:2014

Sterilization of health care products - Moist Heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization
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$138.00
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$244.00
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