ISO/TS 22421:2021 pdf download – Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities.
3.24 humidity measure of water vapour present in a gas Note 1 to entry: Humidity is usually expressed as absolute humidity (i.e. vapour pressure density), relative humidity, or dew point. [SOURCE: ISO 11139:2018, 3.136] 3.25 indicate display a value, condition, or stage of process [SOURCE: ISO 11139:2018, 3.139] 3.26 information supplied by the manufacturer all information related to the identification and use of a sterilizer, in whatever form provided, intended to ensure the safe and effective use of the sterilizer (3.67) Note 1 to entry: For the purposes of this document, shipping documents and promotional material are excluded from information supplied by the manufacturer. However, some authorities having jurisdiction can consider such supplemental information as information supplied by the manufacturer. [SOURCE: ISO 20417:2021, 3.10, modified — “Medical device or accessory” has been changed to “sterilizer” and Notes 1, 3 and 4 to entry have been deleted.] 3.27 installation? qualification IQ process of establishing by objective evidence that all key aspects of the process equipment and ancillary system installation comply with the approved specification [SOURCE: ISO 11139:2018, 3.220.2] 3.28 instructions for use IFU portion of the accompanying information (3.2) that is essential for the safe and effective intended use of a sterilizer (3.67) directed to the user of the sterilizer Note 1 to entry: The instructions for use, or portions thereof, can be located on the display of a sterilizer. [SOURCE: ISO 20417:2021, 3.11, modified — “Medical device or accessory” has been changed to “sterilizer”, “package insert” has been removed, “use” has been changed to “intended use”, Notes 1, 2, 4 and 5 to entry have been deleted and Note 3 to entry has been modified.]
4 General 4.1? Product? definition 4.1.1 When demonstrating that a sterilizer type conforms with this document, sterilizers classified as the same type shall have the same intended use with the same sterilizing agent specification. In addition, unless it has been demonstrated that there is no decrease in the performance of an operating cycle, a sterilizer type shall have: a) the same number of loading or unloading doors; b) all service connections into the chamber in the same orientation; c) the same control system with all fixed sensors located in the same position and orientation; d) the same pre-set programmes of operating cycle(s) including the same cycle parameters. NOTE 1 A mirror image of the original orientation does not constitute a new type. NOTE 2 Where change within the control system does not affect the sequence of stages of the sterilization cycle, and the parameters limiting the cycle performance, or the safety attributes, such a change does not constitute a new type. Conformance is demonstrated by inspection of the technical documentation.