Category Archives: AAMI

AAMI/ISO 8836:2015

Suction catheters for use in the respiratory tract

Published by: 2015-12-29 / 2015-12-29 / 38 pages
Specifies requirements for suction catheters, including closed suction catheters, made of flexible materials and intended for use in suctioning of the respiratory tract. Angled-tip suction catheters (e.g. Coude catheters) and suction catheters with aspirator collectors are not considered to be specialized and are therefore included in the scope of this International Standard.

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AAMI/ISO 7199:2016

Cardiovascular Implants and Artificial Organs – Blood-Gas Exchangers (Oxygenators)

Published by: 2016-11-18 / 2016-11-18 / 24 pages
Specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). Applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. <6 h duration) CPB surgery or (long-term, i.e. >24 h) ECMO procedures. Sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as “sterile”.

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AAMI TIR28:2016

Product adoption and process equivalency for ethylene oxide sterilization

Published by: 2016-11-18 / 2016-11-18 / 22 pages
This technical information report provides guidance for the adoption of new or modified products into an existing validated sterilization process and for the determination of equivalence of a sterilization process as conducted with different equipment. Guidance is intended to augment the ANSI/AAMI/ISO 11135 series in the areas of product adoption and process equivalence.

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AAMI/ISO 5367:2015

Anaesthetic and respiratory equipment – Breathing sets and connectors

Published by: 2015-12-29 / 2015-12-29 / 45 pages
Specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. Applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer’s instructions.

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AAMI/ISO 14708-3:2017

Implants for surgery – Active implantable medical devices – Part 3: Implantable neurostimulators

Published by: 2017-03-02 / 2017-03-02 / 64 pages
Specifies particular requirements for active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system in order to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014.

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AAMI/ISO 26782:2015 & Cor. 1:2015

Anaesthetic and respiratory equipment ? Spirometers intended for the measurement of time forced expired volumes in humans

Published by: 2015-12-29 / 2015-12-29 / 41 pages
Specifies requirements for SPIROMETERS intended for the assessment of pulmonary function in humans weighing more than 10 kg. Applies to a SPIROMETER that measure timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device, irrespective of the measuring method employed.

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AAMI/ISO 15676:2016

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

Published by: 2016-11-18 / 2016-11-18 / 19 pages
Specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). Applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. <6 h duration) CPB surgery or (long-term, i.e. >24 h) ECMO procedures. Sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as “sterile”.

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AAMI/ISO 15675:2016

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

Published by: 2016-11-18 / 2016-11-18 / 20 pages
This standard specifies requirements for sterile, single-use, arterial filters intended to filter and remove emboli, debris, blood clots, and other potentially hazardous solid and gaseous material from the blood of humans during cardiopulmonary bypass surgery.

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AAMI/ISO 12417-1:2015

Cardiovascular implants and extracorporeal systems – Vascular device-drugcombination products – Part 1: General requirements

Published by: 2015-11-15 / 2015-11-15 / 63 pages
Specifies requirements for vascular device-drug combination products based upon current technical and medical knowledge. Outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer.

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AAMI/ISO TIR19024:2016

Evaluation of CPB devices relative to their capabilities of reducing the transmition of gaseous microemboli (GME) to a patient during cardiopulmonary bypass

Published by: 2016-10-09 / 2016-10-09 / 22 pages
Recommends acceptable methodology for conducting gaseous microemboli (GME) testingand discusses limitations of current test methods. Tests described in this document are limited to those conducted using an in vitro circulatory system.

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