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.
ANSI/AAMI ST55:2016/(R)2023

ANSI/AAMI ST55:2016/(R)2023

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Table-top steam sterilizers

€221.00

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ANSI/AAMI/ISO 10993-6:2016

ANSI/AAMI/ISO 10993-6:2016

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Biological evaluation of medical devices—Part 6: Tests for local effects after implantation

€230.00

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ANSI/AAMI/ISO 13485:2016/(R)2019

ANSI/AAMI/ISO 13485:2016/(R)2019

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Medical devices—Quality management systems—Requirements for regulatory purposes

€268.00

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ANSI/AAMI/ISO 15674:2016

ANSI/AAMI/ISO 15674:2016

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Cardiovascular implants and artificial organs—Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

€126.00

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ANSI/AAMI/ISO 15675:2016

ANSI/AAMI/ISO 15675:2016

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Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filters

€126.00

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ANSI/AAMI/ISO 15676:2016

ANSI/AAMI/ISO 15676:2016

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Cardiovascular implants and artificial organs—Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

€144.00

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ANSI/AAMI/ISO 16142-1:2016 [HISTORICAL]

ANSI/AAMI/ISO 16142-1:2016 [HISTORICAL]

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Medical devices—Recognized essential principles of safety and performance of medical devices—Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

€268.00

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ANSI/AAMI/ISO 18241:2016

ANSI/AAMI/ISO 18241:2016

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Cardiovascular implants and extracorporeal systems—Cardiopulmonary bypass systems—Venous bubble traps

€178.00

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ANSI/AAMI/ISO 18242:2016

ANSI/AAMI/ISO 18242:2016

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Cardiovascular implants and extracorporeal systems—Centrifugal blood pumps

€144.00

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ANSI/AAMI/ISO 22442-1:2016

ANSI/AAMI/ISO 22442-1:2016

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Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management

€221.00

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ANSI/AAMI/ISO 22442-2:2016

ANSI/AAMI/ISO 22442-2:2016

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Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling

€144.00

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ANSI/AAMI/ISO 80369-3:2016

ANSI/AAMI/ISO 80369-3:2016

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Small-bore connectors for liquids and gases in healthcare applications—Part 3: connectors for enteral applications

€268.00

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ANSI/AAMI/ISO 80369-3:2016/A1:2019

ANSI/AAMI/ISO 80369-3:2016/A1:2019

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Small-bore connectors for liquids and gases in healthcare applications—Part 3: Connectors for enteral applications—Amendment 1

€144.00

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ANSI/AAMI/ISO 80369-5:2016

ANSI/AAMI/ISO 80369-5:2016

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Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation applications

€379.00

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ANSI/AAMI/ISO 80369-6:2016

ANSI/AAMI/ISO 80369-6:2016

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Small-bore connectors for liquids and gases in healthcare applications—Part 6: Connectors for neuraxial applications

€268.00

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