To ensure correct sterilisation conditions have reached packaged instruments, Adhesive Class 6 Indicator strips monitor one or more sterilisation processes for the purpose of detecting sterilisation failures in packaging, loading or steriliser function. Adhesive backed indicator can be easily attached to compliance records.
Class 6 Indicator with Adhesive
- 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.