Standards for Sterilisation of Equipment and Instruments - Tasmania

Service summary

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.

Service type

Code of Practice

A code of practice can be either a legal requirement or non-legal requirement. Legal codes of practice are defined as a result of legislation. Non-legal codes of practice are defined by industry regulators and bodies.

Administering agency

Department of Health and Human Services
Private Health Regulation

Act(s) name

Health Service Establishments Act 2006 (Tasmania)

Regulation(s) name

Health Service Establishments Regulations 2011 (Tasmania)

Contact details

Enquiries
Department of Health and Human Services
Private Health Regulation


Mailing address:
GPO BOX 125
Hobart, Tasmania 7001

Phone:

03 6166 3853
hselicensing@dhhs.tas.gov.au

Disclaimer

The information contained on the Australian Business Licence and Information Service (ABLIS) web site, or via packages or other sources is intended for general guidance only.

To the full extent permitted by law, the Federal, State, Territory and Local Governments make no representations or warranties (expressed or implied) in relation to the information, including its accuracy, currency or completeness.

The business information provided does not constitute professional or legal advice, nor is the use of any third party resource an endorsement of the information contained, the associated organisation, product or service. It is recommended that you obtain appropriate professional and /or independent legal advice to ensure that the material provided here is relevant to your particular circumstances.

To the full extent permitted by law the Federal, State, Territory and Local Governments, their employees and agents do not accept any liability for any reason, including without limitation, liability in negligence, to any person for the general information which is provided herein, or in respect of anything, including the consequences of anything done, or not done, by any such person in whole or partial reliance upon the information.