Helix Test is a daily steam penetration test for autoclaves. The Process Challenge Device is a reusable device with disposable chemical indicator strips.
- Indicator change from pink to black demonstrates correct steam sterilisation conditions
- 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.