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AAMI




Product Image Item Name- Price
AAMI 11135:1994 - Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization - Includes Errata

AAMI 11135:1994 - Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization - Includes Errata

Establishes requirements and guidance for validation and routine control of ethylene oxide sterilization processes for medical devices. Identical...
$90.00

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AAMI 11607:1997 - Packaging for terminally sterilized medical devices

AAMI 11607:1997 - Packaging for terminally sterilized medical devices

This standard specifies the requirements for single-use materials and reusable containers used forpackaging of terminally sterilized medical devices,...
$40.00

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AAMI 11737-1 - Sterilization of Medical Devices - Microbiological Methods - Part 1: Estimation of the Population of Microorganisms on Product

AAMI 11737-1 - Sterilization of Medical Devices - Microbiological Methods - Part 1: Estimation of the Population of Microorganisms on Product

Specifies general criteria to be applied in the estimation of the population of viable microorganisms on a medical device of component, raw materials...
$80.00

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AAMI 11737-2 - Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

AAMI 11737-2 - Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Specifies the general criteria for tests of sterility on medical devices which have been exposed to a treatment with the sterilizing agent that is a...
$80.00

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AAMI 14971 - Risk management- Part 1: Application of risk management

AAMI 14971 - Risk management- Part 1: Application of risk management

This American National Standard specifies a procedure by which a manufacturer can identify thehazards associated with medical devices and their...
$90.00

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AAMI 15674 - Cardiovascular implants and artificial organs - Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags, 1ed.

AAMI 15674 - Cardiovascular implants and artificial organs - Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags, 1ed.

This American National Standard specifies requirements for sterile, single-use, extracorporealhard-shell cardiotomy/venous reservoir systems and soft...
$70.00

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AAMI 15675 - Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters

AAMI 15675 - Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters

This American National Standard specifies requirements for sterile, single-use, arterial filtersintended to filter and remove emboli, debris, blood...
$70.00

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AAMI 60601-2-2:2006 - Medical Electrical Equipment, Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment

AAMI 60601-2-2:2006 - Medical Electrical Equipment, Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment

$95.00

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AAMI AT6-91(R1996) - Autologous Transfusion Devices

AAMI AT6-91(R1996) - Autologous Transfusion Devices

Establishes labeling and performance requirements, test methods, and terminology that will help establish a reasonable level of safety and efficacy...
$80.00

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AAMI AT6:2005/(R)2011 - Autologous transfusion devices

AAMI AT6:2005/(R)2011 - Autologous transfusion devices

Establishes labeling and performance requirements, test methods, and terminology that will help establish a reasonable level of safety and efficacy...
$100.00

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