Category Archives: AAMI

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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AAMI ST8:2013

Hospital steam sterilizers

Published by: Association for the Advancement of Medical Instrumentation / 04/25/2013 / 43 pages
This standard covers minimum construction and performance requirements for hospital sterilizers
that use saturated steam as the sterilizing agent and have a volume greater than 56.63 liters (2
cubic feet).

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AAMI ST58:2013

Chemical sterilization and high-level disinfection in health care facilities

Published by: Association for the Advancement of Medical Instrumentation / 08/21/2013 / 168 pages
This recommended practice provides guidelines for the selection and use of liquid chemical sterilants (LCSs)/high-level disinfectants (HLDs) and gaseous chemical sterilizers that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) for use in hospitals and other health care facilities. These guidelines are intended to assist health care personnel in the safe and effective use of gaseous chemical sterilizing systems, LCSs/HLDs, and associated equipment.

Included within the scope of this recommended practice are functional and physical design criteria for chemical sterilization and high-level disinfection processing areas; staff qualifications, education, and other personnel considerations; criteria for selecting LCSs/HLDs and gaseous chemical sterilizers; safety and efficacy considerations in the use of LCSs/HLDs and gaseous chemical sterilizers; preparation of devices for processing by chemical sterilization or high-level disinfection; quality control methods; and qulaity process improvement. Definitions of terms and informative annexes are also provided.

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AAMI STBK13-2

AAMI Standards and Recommended Practices – Sterilization, Part 2: Sterilization Equipment, 2013 Edition

Published by: Association for the Advancement of Medical Instrumentation / 2013
The 2013 edition of this sterilization collection for manufacturers and users of sterilization equipment includes 25 AAMI standards and guidance documents. It features recently revised guidance on containment devices (ST77), washer-disinfectors (ST15883-2 and ST15883-3), and hospital steam sterilizers (ST8). It also includes guidance on biological indicators (14161 and 11138 series), documents covering chemical indicators (15882 and 11140 series) packaging (11607 series), EO sterilizers, dry heat sterilizers, table-top steam sterilizers, and more.

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