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AAMI TIR18:2010

Guidance on electromagnetic compatibility of medical devices in healthcare facilities
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TIR19 & A1 Combined

Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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$107.00
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AAMI TIR28:2016 (PDF)

Product adoption and process equivalence for ethylene oxide sterilization
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AAMI TIR29:2012/(R)2017 (PDF)

Guide for process characterization and control in radiation sterilization of medical devices
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AAMI TIR30:2011/(R)2016 (PDF)

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AAMI TIR42:2010

Evaluation of particulates associated with vascular medical devices
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AAMI TIR44:2012

Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact
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AAMI TIR48:2015

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
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AAMI/IEC TIR62296:2009

Considerations of Unaddressed Safety Aspects in the Second Edition of IEC 60601-1 and Proposals for New Requirements
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AAMI/ISO TIR10974:2018 (PDF)

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.
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AAMI/ISO TIR17137:2014 (PDF)

Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
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ANSI/AAMI 26722:2014

Water treatment equipment for hemodialysis and related therapies.
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$107.00
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ANSI/AAMI CI86:2017 (PDF)

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
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ANSI/AAMI EQ56:2013

Recommended practice for a medical equipment management program
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ANSI/AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD)

MEDICAL ELECTRICAL EQUIPMENT - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
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ANSI/AAMI NS4:2013/(R)2017 (PDF)

Transcutaneous electrical nerve stimulators
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ANSI/AAMI PB70:2012

ANSI/AAMI PB70 provides manufacturers with a consistent basis for creating device labeling claims regarding barrier efficacy against liquid-borne microorganisms. Through labeling requirements, the standard is also intended to assist end-users in selecting the appropriate protective apparel and drapes to inhibit the transfer of microorganisms associated with blood, body fluids, and other potentially infectious materials.
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ANSI/AAMI PB70:2012 Red-Line (PDF Format)

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ANSI/AAMI ST15883-1:2009/(R)2014 &A1:2014&A2:2012 (PDF)

(Consolidated Text) (ISO 15883-1:2006, MOD) Washer-disinfectors—Part 1: General requirements, terms and definitions and tests
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ANSI/AAMI ST24:1999/(R)2018 (PDF)

Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
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