AAMI - 14160
Sterilization of single-use medical devices incorporating materials of animal origin—Validation and routine control of sterilization by liquid chemical sterilants
inactive
| Organization: | AAMI |
| Publication Date: | 1 January 1998 |
| Status: | inactive |
| Page Count: | 30 |
scope:
This International Standard specifies requirements for the development, validation, process control and monitoring of the sterilization, by the use of liquid chemical sterilants, of single-use medical devices comprising, in whole or in part, materials of animal origin.
This International Standard does not apply to material of human origin.
This International Standard does not describe a quality assurance system for the control of all stages of manufacture.
Document History
January 1, 2011
Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
This International Standard specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization...
September 1, 1998
Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin - Validation and Routine Control of Sterilization by Liquid Chemical Sterilants
A description is not available for this item.
14160
January 1, 1998
Sterilization of single-use medical devices incorporating materials of animal origin—Validation and routine control of sterilization by liquid chemical sterilants
This International Standard specifies requirements for the development, validation, process control and monitoring of the sterilization, by the use of liquid chemical sterilants, of single-use...