UNLIMITED FREE
ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Select Your Free Newsletters

Industry Newsletters

Select Your Free Product Alerts

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

AAMI - TIR40

Sterilization of health care products—Radiation— Guidance on dose setting utilizing a Modified Method 2

active, Most Current
Organization: AAMI
Publication Date: 1 January 2018
Status: active
Page Count: 37
scope:

Inclusions

This TIR describes a modification to Methods 2A and 2B of ANSI/AAMI/ISO 11137-2 that reduces the number of incremental doses needed to determine the minimum dose required to achieve a predetermined sterility assurance level (SAL).

This method of sterilization dose establishment may be used to meet the product qualification requirements specified in ANSI/AAMI/ISO 11137-2 when product bioburden is low in number or resistance and has demonstrated historical consistency.

Exclusions

This method of sterilization dose establishment is not to be used to meet the product qualification requirements specified in ANSI/AAMI/ISO 11137-2 when the product bioburden has not been evaluated.

Document History

AAMI TIR40
January 1, 2018
Sterilization of health care products-Radiation- Guidance on dose setting utilizing a Modified Method 2
Inclusions This TIR describes a modification to Methods 2A and 2B of ANSI/AAMI/ISO 11137-2 that reduces the number of incremental doses needed to determine the minimum dose required to achieve a...
TIR40
January 1, 2018
Sterilization of health care products—Radiation— Guidance on dose setting utilizing a Modified Method 2
Inclusions This TIR describes a modification to Methods 2A and 2B of ANSI/AAMI/ISO 11137-2 that reduces the number of incremental doses needed to determine the minimum dose required to achieve a...
TIR40
January 1, 2009
Sterilization of health care products-Radiation-Guidance on dose setting utilizing a Modified Method 2
Inclusions This TIR describes a modification to Methods 2A and 2B of ANSI/AAMI/ISO 11137-2 that reduces the number of incremental doses needed to determine the minimum dose required to achieve a...
TIR40
January 1, 2009
Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2
Inclusions This TIR describes a modification to Methods 2A and 2B of ANSI/AAMI/ISO 11137-2 that reduces the number of incremental doses needed to determine the minimum dose required to achieve a...

References

This document references:
ISO 11137-1 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
Published by ISO on November 1, 2018
A description is not available for this item.
This document references:
ISO 11137-2 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
Published by ISO on June 1, 2013
This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the...
This document references:
ISO 11137-3 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
Published by ISO on June 1, 2017
This document gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a...
This document references:
ISO 11737-1 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
Published by ISO on January 1, 2018
This document specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw...
This document references:
ISO 11737-2 - Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Published by ISO on December 1, 2019
This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that...
View Less
View All
Advertisement