If you operate a health service establishment, you will need to sterilise all medical equipment and instruments in accordance with the prescribed standard. A health service establishment includes private hospitals, day-procedure centres and residential care services.
The prescribed standard is AS / NZS 4187-2003: Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities.
You may also need to comply with the following standards if they are applicable to your situation:
- IS EN ISO 15883-1:2009 Washer-disinfectors - Part 1: General requirements, Terms and Definitions and Tests;
- IS EN ISO 15883-2:2009 Washer-disinfectors - Part 2: Requirements and Test of Washer-disinfectors Employing Thermal Disinfection for Surgical Instruments, Anaesthetic Equipment, Bowls, Dishes, Receivers, Utensils, Glassware, etc;
- ISO 17664:2004 - Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices;
- IS EN ISO 15883-5:2006 Washer-disinfectors - Part 5: Test Soils and Methods for Demonstrating Cleaning Efficacy; or
- IS EN ISO 11140-1: 2009 Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements.
Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.