Association for the Advancement of Medical Instrumentation (AAMI)

Association for the Advancement of Medical Instrumentation (AAMI)
AAMI CR513:2024

AAMI CR513:2024

Active Most Recent

Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing

€144.00

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ANSI/AAMI/ISO 13408-1:2023

ANSI/AAMI/ISO 13408-1:2023

Active Most Recent

Aseptic processing of health care products—Part 1: General requirements

€311.00

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ANSI/AAMI/ISO 11607-1:2019/A1:2023

ANSI/AAMI/ISO 11607-1:2019/A1:2023

Active Most Recent

Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management

€178.00

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ANSI/AAMI/ISO 11607-2:2019/A1:2023

ANSI/AAMI/ISO 11607-2:2019/A1:2023

Active Most Recent

Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management

€144.00

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ANSI/AAMI EQ56:2024

ANSI/AAMI EQ56:2024

Active Most Recent

Standard for a medical equipment management program

€251.00

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ANSI/AAMI EQ103:2024

ANSI/AAMI EQ103:2024

Active Most Recent

Alternate equipment management (AEM) program in healthcare delivery organizations (HDOs)

€221.00

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ANSI/AAMI EQ110:2024

ANSI/AAMI EQ110:2024

Active Most Recent

Healthcare technology management (HTM) educational programs

€144.00

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AAMI TIR17:2024

AAMI TIR17:2024

Active Most Recent

Compatibility of materials subject to sterilization

€311.00

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AAMI TIR109:2025

AAMI TIR109:2025

Active Most Recent

External transport of reusable medical devices for processing

€221.00

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ANSI/AAMI HE75:2025

ANSI/AAMI HE75:2025

Active Most Recent

Human factors engineering—Design of medical devices

€706.00

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AAMI TIR130:2025

AAMI TIR130:2025

Active Most Recent

Best practices for designing accessible at-home diagnostic test kits

€311.00

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AAMI TIR11:2005/(R)2021

AAMI TIR11:2005/(R)2021

Active Most Recent

Selection and use of protective apparel and surgical drapes in health care facilities

€221.00

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AAMI TIR29:2012/(R)2017 [HISTORICAL]

AAMI TIR29:2012/(R)2017 [HISTORICAL]

Withdrawn Most Recent

Guide for process characterization and control in radiation sterilization of medical devices

€251.00

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AAMI TIR30:2011/(R)2016 [HISTORICAL]

AAMI TIR30:2011/(R)2016 [HISTORICAL]

Withdrawn Most Recent

A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

€251.00

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AAMI TIR31:2008

AAMI TIR31:2008

Active Most Recent

Process challenge devices/test packs for use in health care facilities

€221.00

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