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AAMI - 11137-3

Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects

inactive
Organization: AAMI
Publication Date: 1 January 2006
Status: inactive
Page Count: 31
scope:

This part of ISO 11137 gives guidance on the requirements in ISO 11137 parts 1 and 2 relating to dosimetry. Dosimetry procedures related to the development, validation and routine control of a radiation sterilization process are described.

Document History

11137-3
January 1, 2017
Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control
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...
AAMI 11137-3
January 1, 2017
Sterilization of health care products-Radiation-Part 3: Guidance on dosimetric aspects of development, validation and routine
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...
11137-3
January 1, 2006
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
This part of ISO 11137 gives guidance on the requirements in ISO 11137 parts 1 and 2 relating to dosimetry. Dosimetry procedures related to the development, validation and routine control of a...
11137-3
January 1, 2006
Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects
This part of ISO 11137 gives guidance on the requirements in ISO 11137 parts 1 and 2 relating to dosimetry. Dosimetry procedures related to the development, validation and routine control of a...
11137-3
January 1, 2004
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE
A description is not available for this item.

References

This document references:
AAMI TIR29 - Guide for process characterization and control in radiation sterilization of medical devices
Published by AAMI on January 1, 2012
This technical information report (TIR) provides additional guidance for establishing and meeting the irradiator Operational Qualification (OQ), Performance Qualification (PQ), and routine control...
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/ASTM 51608 - Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV
Published by ISO on March 15, 2015
This practice outlines the dosimetric procedures to be followed during installation qualification, operational qualification, performance qualification and routine processing at an X-ray...
This document references:
ISO/ASTM 51650 - Practice for use of a cellulose triacetate dosimetry system
Published by ISO on June 1, 2013
This is a practice for using a cellulose triacetate (CTA) dosimetry system to measure absorbed dose in materials irradiated by photons or electrons in terms of absorbed dose to water. The CTA...
This document references:
ASTM E2232 - Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications
Published by ASTM on December 1, 2020
This guide describes different mathematical methods that may be used to calculate absorbed dose and criteria for their selection. Absorbed-dose calculations can determine the effectiveness of the...
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:
AAMI TIR29 - Guide for process characterization and control in radiation sterilization of medical devices
Published by AAMI on January 1, 2012
This technical information report (TIR) provides additional guidance for establishing and meeting the irradiator Operational Qualification (OQ), Performance Qualification (PQ), and routine control...
This document is referenced by:
TIR40 - Sterilization of health care products—Radiation— Guidance on dose setting utilizing a Modified Method 2
Published by AAMI on January 1, 2018
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...
This document is referenced by:
AAMI ST67 - Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
Published by AAMI on January 1, 2019
Inclusions This standard specifies requirements and provides guidance on selecting approaches to establish assurance of sterility for a health care product labelled as “sterile.” Approaches to...
This document is referenced by:
ASTM F2051 - Standard Specification for Implantable Saline Filled Breast Prosthesis
Published by ASTM on July 10, 2000
This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction,...
This document is referenced by:
ASTM F2529 - Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
Published by ASTM on February 1, 2013
This guide covers general guidelines to evaluate the effectiveness of DBM-containing products intended to cause and/or promote bone formation when implanted or injected in vivo. This guide is...
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