Sterilization of health care products - Radiation Requirements for development, validation and routine control of a sterilization process for medical devices
Standards Australia
Adopts ISO 11137-1:2006 to specify requirements for the development, validation and routine control of a radiation sterilization process employing irradiations.
RECONFIRMATION NOTICE
Technical Committee HE-023 has reviewed the content of this publication and in accordance with Standards Australia procedures for reconfirmation, it has been determined that the publication is still valid and does not require change.
Certain documents referenced in the publication may have been amended since the original date of publication. Users are advised to ensure that they are using the latest versions of such documents as appropriate, unless advised otherwise in this Reconfirmation Notice.
Approved for reconfirmation in accordance with Standards Australia procedures for reconfirmation on 06 December 2016.
Approved for reconfirmation in New Zealand on behalf of the Standards Council of New Zealand on 10 August 2017.
The following are represented on Technical Committee HE-023:
Australasian College for Infection Prevention and Control
Australian Chamber of Commerce and Industry
Australian College of Perioperative Nurses
Australian Dental Association
Australian Dental Industry Association
Australian Industry Group
Australian Institute of Packaging
Australian Nursing and Midwifery Federation
Day Hospitals Australia
Department of Health (WA)
Department of Health and Human Services (VIC)
Federal Sterilizing Research and Advisory Council of Australia
Gastroenterological Nurses College of Australia
Institute of Hospital Engineering Australia
Medical Technology Association of Australia
New Zealand Nurses Organisation
New Zealand Sterile Services Association
NSW Health
Queensland Health
Royal Australian College of General Practitioners
Royal College of Pathologists of Australasia
SA Health
Therapeutic Goods Administration
| Document Type | Standard |
| Status | Current |
| Publisher | Standards Australia |
| ProductNote | Reconfirmed 15/09/2017. This standard has been reconfirmed in Australia in 2017 and remains current in New Zealand. Reconfirmation Notice 15/09/2017 |
| Committee | HE-023 |
| Supersedes |
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