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AAMI TIR12:2010 Red-line (PDF Format)

Includes Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers and red-line format of document showing changes between the current and 2004 version in red and strikethrough, PDF format.

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AAMI TIR20:2001

Parametric release for ethylene oxide sterilization
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AAMI TIR31:2008

Process challenge devices/test packs for use in health care facilities
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AAMI TIR39:2009/(R)2017 (PDF)

Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
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AAMI TIR55:2014

Human factors engineering for processing medical devices
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AAMI TIR66:2017

Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
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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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AAMI/ISO TIR19024:2016 (PDF)

Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
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ANSI/AAMI ST15883-1:2009/(R)2014

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests
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ANSI/AAMI ST15883-2:2013/(R)2015

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
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ANSI/AAMI ST15883-3:2012/(R)2015

Washer-disinfectors, Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers.
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ANSI/AAMI ST24:1999/(R)2013

Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities.
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ANSI/AAMI ST50:2004/(R)2010

Dry Heat (Heated Air) Sterilizers
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ANSI/AAMI ST55:2016 (PDF)

Table-top Steam Sterilizers
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ANSI/AAMI ST77:2013

Containment devices for reusable medical device sterilization, 2nd ed.
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ANSI/AAMI ST8:2013

Hospital steam sterilizers
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ANSI/AAMI/ISO 11138-1:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 1: General requirements
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ANSI/AAMI/ISO 11138-2:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes
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ANSI/AAMI/ISO 11138-3:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes
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ANSI/AAMI/ISO 11138-4:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes
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