Category Archives: AAMI

AAMI/ISO 15223-1:2016

Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements

Published by: 2016-12-15 / 2016-12-15 / 38 pages
This part of ISO 15223 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements. These symbols may be used on the medical device itself, on its packaging or in the associated documentation.

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AAMI/IEC TIR80001-2-8:2016

Application of risk management for IT networks incorporating medical devices – Part 2-8: Application guidance Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2

Published by: 2016-11-18 / 2016-11-18 / 57 pages
This technical report provides guidance for the application of the framework outlined in AAMI/IEC 80001-2-2. Managing the RISK in connecting MEDICAL DEVICES to IT-networks requires the disclosure of security-related capabilities and RISKS. AAMI/IEC 80001-2-2 presents a framework for this disclosure and the security dialog that surrounds the AAMI/IEC 80001-1 RISK MANAGEMENT of IT-networks. AAMI/IEC 80001-2-2 presents an informative set of common, descriptive security-related capabilities that are useful in terms of gaining an understanding of user needs. This report addresses each of the SECURITY CAPABILITIES and identifies SECURITY CONTROLS for consideration by all stakeholders during RISK MANAGEMENT activities, supplier selection, device selection etc.

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AAMI/IEC 80601-2-58:2014/A1:2016

Amendment 1 to Medical electrical equipment – Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

Published by: 2016-10-07 / 2016-10-07 / 19 pages
Modifies the content of the second edition of IEC 80601-2-58 and includes an integration of updated definition of essential performance and updating the essential performance analysis, removing the dates of collateral and general standard references, addition of symbols, and updating of EMC requirements.

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AAMI TIR14:2016

Contract sterilization using ethylene oxide

Published by: 2016-06-05 / 2016-06-05 / 19 pages
This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered.

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AAMI/ISO 80369-3:2016

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

Published by: 2016-06-05 / 2016-06-05 / 50 pages
This standard specifies the dimensions and requirements for the design and functional performance of SMALLBORE CONNECTORS intended to be used for CONNECTIONS on ENTERAL MEDICAL DEVICES and ACCESSORIES.

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AAMI TIR35:2016

Sterilization of health care products – Radiation sterilization – Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits

Published by: 2016-06-05 / 2016-06-05
Describes approaches to the selection and auditing of a sterilization dose that may reduce the number of product items required while maintaining assurance of attaining the desired sterility assurance level (SAL). This approach addresses sampling plans for verification dose experiments and sterilization dose audits. In addition the approaches to adopting a product into an established product family are defined.

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AAMI/IEC TIR62354:2015

General testing procedures for medical electrical equipment

Published by: 2015-04-12 / 2015-04-12
This technical report applies to medical electrical equipment. The object of this technical report is
to provide guidance on general testing procedures according to IEC 60601-1:1988 (including the
collateral provisions of IEC 60601-1-1:2000) and IEC 60601-1:2005 and IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012.

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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 (IEC 60601-1-11:2015, MOD)

Published by: 2015-08-25 / 2015-08-25 / 66 pages
This standard applies to the safety and essential performance of medical electrical equipment and
medical electrical systems, which are intended by the manufacturer for use in home care
applications usually without continual professional supervision and temporarily in the clinical
environment. These medical electrical equipment and medical electrical systems will frequently be
used in locations where driving power and safety means of the electrical installation is not reliable.
These medical electrical equipment and medical electrical systems will often be supervised by
non-healthcare personnel with different levels of training.

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AAMI ST91:2015

Flexible and semi-rigid endoscope processing in health care facilities

Published by: Association for the Advancement of Medical Instrumentation / 2015-04-10 / 58 pages
Provides guidelines for precleaning, leak-testing, cleaning, packaging (where indicated), storage, high-level disinfecting, and/or sterilizing of flexible gastrointestinal (GI) endoscopes, flexible bronchoscopes, surgical flexible endoscopes (e.g., flexible ureteroscopes), and semi-rigid operative endoscopes (e.g., choledochoscopes) in health care facilities. These guidelines are intended to provide comprehensive information and direction for health care personnel in the processing of these devices and accessories.

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AAMI/IEC 60601-1-2:2014

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

Published by: Association for the Advancement of Medical Instrumentation/International Electrotechnical Commission / 2014-05-09 / 102 pages
Specifies general requirements and tests for basic safety and essential performance with regard
to electromagnetic disturbances of medical electrical (ME) equipment and ME systems. They are
in addition to the requirements of the general standard and serve as the basis for particular
standards. Applicability of this collateral standard includes ME equipment and ME systems that
have been found to have no essential performance.

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