ISO/TS 22421:2021 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities.
measure of water vapour present in a gas
Note I to entry: Humidity is usually expressed as absolute humidity (i.e. vapour pressure density), relative humidity, or dew point.
[SOtJRCE: ISO 11139:2018, 3.136]
display a value, condition, or stage of process
[SOURCE: ISO 11139:2018, 3.1391
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 ito 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.I
installation qualification
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]
instructions for use
portion of the accompanying information (3.2) that is essential for the safe and effective intended use of
a sterilizer (167) 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.]
written, printed, or graphic information appearing on the sterilizer (167) itself
Note 1 to entry: Label includes the marking on the sterilizer.
[SOtJRCE: ISO 20417:2021, 3.12, modified — The term “item” has been replaced with “sterilizer”, reference to packaging and provision of multiple items has been deleted, Notes 1 and 3 to entry have been deleted, and Note 2 to entry has been designated as Note 1.]
product, equipment, or materials to be processed together within an operating cycle (142)
[SOURCE: ISO 11139:2018, 3.155]ISO/TS 22421 pdf download.