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.
- Temperature Indicators Staff
- Tags: CSSD ISO 11140-1 Medical Sterilisation Sterile Services
