Association for the Advancement of Medical Instrumentation (AAMI)

Association for the Advancement of Medical Instrumentation (AAMI)
AAMI (Association for the Advancement of Medical Instrumentation) is a non-profit organization that accredits manufacturers and suppliers of medical devices. Its accreditation program assesses compliance with quality and performance standards for medical devices. AAMI also provides guidelines and recommendations for the design, testing, and labeling of medical devices. By using AAMI-accredited devices, healthcare providers can ensure their patients receive safe and effective care.
AAMI TIR50:2014/(R)2025

AAMI TIR50:2014/(R)2025

Active Most Recent

Post-market surveillance of use error management

€221.00

View more
AAMI TIR51:2014/(R)2025

AAMI TIR51:2014/(R)2025

Active Most Recent

Human factors engineering—Guidance for contextual inquiry

€144.00

View more
ANSI/AAMI/IEC 60601-1-2:2014

ANSI/AAMI/IEC 60601-1-2:2014

Active Most Recent

Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests

€520.00

View more
AAMI/ISO TIR80001-2-6:2014

AAMI/ISO TIR80001-2-6:2014

Active Most Recent

Application of risk management for IT-networks incorporating medical—Application guidance—Part 2-6: Guidance for responsibility agreements

€144.00

View more
AAMI TIR63:2014/(R)2023

AAMI TIR63:2014/(R)2023

Active Most Recent

Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection

€144.00

View more
ANSI/AAMI/IEC 60601-1-2:2014/A1:2021

ANSI/AAMI/IEC 60601-1-2:2014/A1:2021

Active Most Recent

Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests, Amendment 1

€334.00

View more
ANSI/AAMI/IEC 60601-1-2:2014 & A1:2021 Redline

ANSI/AAMI/IEC 60601-1-2:2014 & A1:2021 Redline

Active Most Recent

Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests Consolidated Text, Redline Version

€1,476.00

View more
AAMI TIR56:2013/(R)2024

AAMI TIR56:2013/(R)2024

Active Most Recent

Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices

€178.00

View more
ANSI/AAMI NS4:2013/(R)2017

ANSI/AAMI NS4:2013/(R)2017

Active Most Recent

Transcutaneous electrical nerve stimulators

€144.00

View more
ANSI/AAMI ST15883-2:2013/(R)2023 (ISO 15883-2:2006 MOD)

ANSI/AAMI ST15883-2:2013/(R)2023 (ISO 15883-2:2006 MOD)

Active Most Recent

Washer-disinfectors—Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.

€144.00

View more
ANSI/AAMI ST77:2013/(R)2018

ANSI/AAMI ST77:2013/(R)2018

Active Most Recent

Containment devices for reusable medical device sterilization

€178.00

View more
ANSI/AAMI/ISO 11137-2:2013/(R)2019

ANSI/AAMI/ISO 11137-2:2013/(R)2019

Active Most Recent

Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose

€289.00

View more
ANSI/AAMI ST8:2013/(R)2018

ANSI/AAMI ST8:2013/(R)2018

Active Most Recent

Hospital steam sterilizers

€221.00

View more
AAMI TIR49:2013/(R)2020

AAMI TIR49:2013/(R)2020

Active Most Recent

Design of training and instructional materials for medical devices used in non-clinical environments

€251.00

View more
ANSI/AAMI EC53:2013/(R)2020

ANSI/AAMI EC53:2013/(R)2020

Active Most Recent

ECG trunk cables and patient leadwires

€144.00

View more