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AAMI 10993-7

Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals

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Organization: AAMI
Publication Date: 1 January 2008
Status: active
Page Count: 18
scope:

This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how this document is applied, are also included in the informative annexes.

EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO 10993.

NOTE This part of ISO 10993 does not specify limits for ethylene glycol (EG).

Document History

AAMI 10993-7
January 1, 2008
Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO...
AAMI 10993-7
January 1, 2008
Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO...
10993-7
January 1, 2008
Biological evaluation of medical devices— Part 7: Ethylene oxide sterilization residuals
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO...
10993-7
December 1, 1995
Biological Evaluation of Medical Devices, Part 7: Ethylene Oxide Sterilization Residuals
A description is not available for this item.
10993-7
December 1, 1995
Biological Evaluation of Medical Devices, Part 7: Ethylene Oxide Sterilization Residuals
A description is not available for this item.

References

This document references:
ISO 10993-3 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Published by ISO on October 1, 2014
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially...
This document references:
10993-17 - Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
Published by ISO on September 1, 2023
This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is...
This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
ISO 10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Published by ISO on January 1, 2021
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological...
This document references:
ASTM E691 - Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
Published by ASTM on October 1, 2020
This practice describes the techniques for planning, conducting, analyzing, and treating the results of an interlaboratory study (ILS) of a test method. The statistical techniques described in this...
This document is referenced by:
ISO 11979-8 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
Published by ISO on April 1, 2017
This document specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and...
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