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ISO 11140-1 Chemical Indicator Classes Explained

Chemical indicators used in medical device sterilisation are classified under ISO 11140-1 into six classes — Class 1 through Class 6 — each with a different function, placement, and level of process assurance. Selecting the correct class for each application is a regulatory and best practice requirement for sterile services departments, CSSD units, theatre sterilisation teams, and any facility that processes reusable medical devices. This guide explains what each class does, when to use it, and how they relate to common sterilisation systems including steam, hydrogen peroxide, ethylene oxide, and low temperature steam-formaldehyde.

Technical Bulletin: Lead-Free, Latex-Free Autoclave Tape for Healthcare Sterilisation

Autoclave tape — also known as sterilisation process indicator tape — is one of the most widely used Class 1 chemical indicators in healthcare sterilisation. Applied to the outside of wrapped instrument sets, cassettes, and pouches before loading into the autoclave, it provides immediate visual confirmation that the package has been processed — and that it should not be mistaken for an unprocessed item on the way to or from the sterile services department. But not all autoclave tapes are the sam