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Hot Topics - AS3551 Draft 2010

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Public comment needed for AS/NZS 3551 Technical management program for medical devices


Mike Flood & Stuart Clifton presented this workshop around Australia in July 2010.

AS3551 Draft Workshop July 2010 (pdf 105kB)
This power point describes:

1. How the standard has got to this draft state
2. The main changes between the 2004 standard and this draft

The draft standard, DR10023, is available for free (until mid-August 2010) from Standards Australia.

Any comments and changes you suggest need to be made formally and will noot be taken seriously without your suggestions for improvement. The link to the formal submission form is in this power point, and also in the draft standard, DR10023.

Here are some of the issues that may still need timprovement (quick notes from the Adelaide meeting):

  • Definitions
    Separation of the hospital organisation from the service entity and responsibilities of the two
  • Equipment in the home
    What happens when the hospital clinician prescribes equipment for short-term (hospital@home) or long-term home use? Who is responsible for its safe use, functional testing etc. Does it matter if it is loaned from the hospital vs bought by the patient? Who should be checking th apatient knows the safe use and function tests? How does the patient know what to do if the equipment fails? Who is responsible for tracking and completing for eg, 20,000 hr ventilator service etc? Note: Rob Wiseman commented that 80 fires in NSW in past 10 yrs have been caused by medical equipment at home.
  • Software documentation
    Is the requirement to track software versions and operating system versions a requirement?
  • Training
    Should training of users be included?
    Should training level of service staff be stated?
  • Title
    Is the title appropriate? Does Technology need to be stated or does it cover more than technology?
    What term should be used throughout – Medical Device or Medical Equipment?
  • Testing networked systems
    How to test patient monitoring systems that are networked?
    There is much detail on simple electrical tests, but little on complex systems that have complex earth systems (optical network may make this easier). Should it refer to other standards for testing these (IEC xxxx)?
  • Modification vs repair
    Are modifications to devices clear? When do you become a manufacturer?
  • Risk management
    Is Appendix A necessary –or should it just refer to other Risk Management standards?
  • Test and tag
    How should AS3760 be addressed so there is no need to test & tag medical devices?




Updated September 28, 2010