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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...
Particular requirements for equipment used to sterilize wrapped items (such as instruments and utensils) and porous materials (e.g. towels and bed linen). To be read in conjunction with BS 3970:Part 1
Requirements, additional to those in Part 1, for sterilizers in which heat transfer is effected by saturated steam under phase-boundary conditions.
Parametric release is the declaration of adequacy of routine processing for a validated sterilization process based solely on measurement and documentation of physical process parameters rather than results of biological indicator or product sterility evaluation. This technical information...
This Standard provides recommended practices for emergency sterilization in health care facilities. The term "emergency sterilization", as used herein, is synonymous with "flash sterilization" and sterilization by the "unwrapped method". These recommended practices are...
Requirements for equipment, used in clinics and surgeries and by therapists, to sterilize implements that are likely to pierce the skin. The equipment requires no plumbing or permanent connection to an electrical supply. To be read in conjunction with BS 3970-1
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...
For sterilizers used in hospitals and other medical, clinical and ancilliary institutions.
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:...
This TIR addresses medical devices that are processed by ethylene oxide (EO) sterilization using conventional or parametric product release. The document applies to the following situations for the sterilization of medical devices: a) a new product is being added to the...
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.
This Standard specifies essential elements for using steam 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. Notes: 1) The term...
This standard for retreatment of sterilizable medical equipment in health care sector gives some requirements for products, processes etc.
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...
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...
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 European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization...
This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization...
