1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
  2. Hello and Welcome to The Quality Forum Online...Continuing in the spirit of People Helping People !
    Dismiss Notice
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

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

    Joined:
    Jul 31, 2015
    Messages:
    133
    Likes Received:
    70
    Trophy Points:
    27
    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

    Joined:
    Aug 6, 2015
    Messages:
    28
    Likes Received:
    22
    Trophy Points:
    2
    Location:
    UK
    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
     
    Ronen E likes this.
  3. Steve Kent

    Steve Kent Member

    Joined:
    Aug 3, 2015
    Messages:
    25
    Likes Received:
    25
    Trophy Points:
    12
    Location:
    UK
    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
     
    Ronen E likes this.
  4. Marcelo Antunes

    Marcelo Antunes Active Member

    Joined:
    Jul 31, 2015
    Messages:
    50
    Likes Received:
    59
    Trophy Points:
    17
    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

    Joined:
    Jul 31, 2015
    Messages:
    133
    Likes Received:
    70
    Trophy Points:
    27
    Thank you all, mates.
    I'll let you know if I find out anything interesting.
    Cheers,
    Ronen.
     

Share This Page