Ensures correct sterilisation conditions have reached packaged instruments. Class 6 Indicator strips monitor one or more sterilisation processes for the purpose of detecting sterilisation failures in packaging, loading or steriliser function.
Class 6 Indicator
- Steam, rather than heat alone is required to initiate colour change
- Provides permanent record of compliance
- 3.5 minutes at 134°C
All decontamination equipment should be subjected to validation, testing, maintenance and servicing as recommended by the manufacturer/ supplier. All records of these procedures should be retained for audit/inspection.
The validation schedules for sterilizers outlined in paragraph 11.5 and Chapter 12 are part of the essential quality requirements.
Section 12.5 contains the Periodic Tests section for Sterilisers- the table refers to Steam Penetration tests being carried out daily.