AS/NZS 4815:2006

Sets out procedures and process development which can be validated for the cleaning, disinfection and sterilization of reusable medical and surgical instruments and equipment, and maintenance of associated environments in office-based health care facilities not involved in complex patient procedures and processes. Suitable for medical, surgical and allied health facilities and skin penetration establishments. May also be suitable for application to the instruments and equipment used exclusively on animals in veterinary practice. Does not apply to day surgical or day procedures centres or items that may be contaminated with prions capable of causing TSEs, e.g. Creutzfeldt-Jakob.

This Standard sets out procedures and process development which can be validated for the cleaning, disinfection and sterilization of reusable medical and surgical instruments and equipment, and maintenance of associated environments in office-based health care facilities not involved in complex patient procedures and processes.The Standard is suitable for medical, dental and allied health facilities and skin penetration establishments. The Standard may also be suitable for application to the instruments and equipment used exclusively on animals in veterinary practice.The Standard does not apply to the reprocessing of items intended by the manufacturer for single use only.Goods such as dressings and bandages should be obtained sterile from commercial sources, ready for use. This Standard also encompasses the environmental conditions for sterility maintenance of both in-house produced and commercially supplied sterile items.Reference to AS/NZS 4187 is required for complex cleaning, disinfecting and sterilizing processes, such as those involving anaesthetic equipment processing, endoscopy equipment processing and processes involving low temperature sterilizing systems. This Standard does not apply to day surgical or day procedures centres, and reference should be made to AS/NZS 4187.The Standard also does not apply to items that may be contaminated with prions capable of causing Transmissible Spongiform Encephalopathies (TSEs), e.g. Creutzfeldt-Jakob Disease (CJD). Reference should be made to the ‘Guidelines for the Prevention of Transmission of Infectious Diseases in the Health Care Setting’ for advice on reprocessing of these items. These ‘Guidelines for the Prevention of Transmission of Infectious Diseases in the Health Care Setting’ are available at www.icg.health.gov.au.

Originated as AS/NZS4815:2001 Second edition 2006.