For Support/Comment – Proposed Australian Modified Adoption of ISO 80601-2-12:2011
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Standards Australia has received the following Project Proposal:

Proposed Australian Modified Adoption of ISO 80601-2-12:2011

from the Therapeutic Goods Administration (TGA) for the modified adoption of ISO 80601-2-12:2011 Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators.

We welcome your review, comment on and/or endorsement, as appropriate.

The TGA hopes this proposal can be submitted during Round 17 of Standards Australia’s Project Prioritisation which opens Wednesday 1 August 2018, with applications accepted until 5pm Friday 31 August 2018. More detailed information on this process can be found on our website.

This and all other proposals will be assessed on three key criteria:

  1. Net benefit case
  2. Well-defined scope of work
  3. Stakeholder consultation and evidenced support

 

Please review the above proposal and provide any feedback or endorsement to the TGA by COB Friday, 10 August 2018.

 

To provide endorsement or ask any questions, please contact:

 

Dr Lee Walsh CPEng NER

Laboratories Branch | Therapeutic Goods Administration

lee.walsh@health.gov.au