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This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this...
This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this...
The General Services Administration has authorized the use of this commercial item description. This commercial item description describes combination paper/plastic sterilization tubing for use in steam and ethylene oxide sterilization, and closed with a heat sealer or with...
The General Services Administration has authorized the use of this Commercial Item Description as a replacement for MIL-I-36789, which is cancelled. This Commercial Item Description covers one type of sensitized paper or fabric test record for determination of air elimination from within a...
The General Services Administration has authorized the use of this Commercial Item Description. This Commercial Item Description covers a disposable wrapper suitable for wrapping surgical supplies for sterilization by autoclaving.
Introduction Healthcare sterile processing and medical device manufacturing professionals of today need a comprehensive understanding of sterilization processes and how to produce sterile product. Device manufacturers are required to provide information to the Food and Drug Administration...
General This recommended practice provides guidelines for the selection and use of liquid chemical sterilants (LCSs)/highlevel disinfectants (HLDs) and gaseous chemical sterilizers that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) for use in hospitals and...
1.1.1 This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. NOTE Although the scope of this International...
This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing,...
This Standard specifies essential elements for using chemical processes to sterilize medical devices in health care settings, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to health care setting personnel and patients. Note: The term...
General This recommended practice provides guidelines for EO sterilization processing in hospitals and other health care facilities. These guidelines are intended to promote sterility assurance and to assist health care personnel in the proper use of processing equipment. These guidelines...
Inclusions This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. NOTE Although the scope of this International Standard is limited to medical devices, it specifies requirements and...
Inclusions This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. NOTE Although the scope of this International...
Inclusions This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. NOTE Although the scope of this International...
Inclusions This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. NOTE Although the scope of this International...
Inclusions This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. NOTE Although the scope of this part of ISO 17665 is limited to medical devices, it specifies requirements and provides...
This International Standard specifies requirements for the use of moist heat in sterilization process development, validation of the sterilization process and control of routine sterilization. It covers all moist heat processes, including saturated steam and air-steam mixtures,...
