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ISO 18562 - Biocompatibility evaluation of respiratory gas pathways in healthcare applications

Discussion in 'Other Medical Device Regulations World-Wide' started by Ronen E, Aug 26, 2015.

  1. Ronen E

    Ronen E Well-Known Member

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    Hello all,

    Does anyone have any information regarding the prospects of this family of standards (parts 1-4) publication? Any known timelines...?

    I was able to find that drafts have been issued (DIS?) in early 2014, however I couldn't tell what's up next, and when.

    Does anyone know where any released DIS versions of these standards can be obtained (preferably online)?

    Thanks,
    Ronen.
     
  2. Pads38

    Pads38 Member

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    Hi Ronen,

    All 4 of those standards is shown as being at stage 40.00 - the 'Enquiry' stage after the DIS has been produced.
    Stages explained here:-
    http://www.iso.org/iso/home/standards_development/resources-for-technical-work/stages_table.htm

    All contacts are referred to the secretariat:- dave.osborn (at) philips.com

    Standards Australia is listed as a 'Participating Country' but that relates to ISO/TC121/SC3 as a whole, so there may not be any involvement on the working group involved (WG13).

    So, I would suggest your best bet may be that a request to Dave Osborn for contact with the convenor of WG13
     
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  3. Steve Kent

    Steve Kent Member

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    Hi Ronen,

    From our trade body standards committee rep., the only addition I can add is the draft DISs for all 4 were circulated on 26th June 2015 for 5-month ballot and comments.

    Steve
     
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  4. Marcelo Antunes

    Marcelo Antunes Active Member

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    ISO does not normally sell drafts at DIS stage (only FDIS), but this may change due to the recent change to optional FDIS. But in the case of 18562, they are not selling the DISs.
     
  5. Ronen E

    Ronen E Well-Known Member

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    Thank you all, mates.
    I'll let you know if I find out anything interesting.
    Cheers,
    Ronen.