This posts discusses BSI’s article on the status of the draft ISO 13485:201X standard.
Recently BSI published an e-newsletter and in it was an excellent article explaining the status of the next draft revision of ISO 13485 and some of the details of the draft standard. The development of this standard project is being managed under the ISO Technical Committee 210, Working Group 1. The Committee Draft (CD) received over 500 comments and from that the committee published the Draft International Standard (DIS) on 20 Feb 2014. So, now we are within the required 5 month voting period for comments with the period closing on 20 July 2014. Note, that some National Committees may ask for feedback up to a couple weeks or more earlier than the 20 July 2014 deadline so get your comments in fast to your National Committee wherever in the world you are. For most National Committees you or your company have to be members of that committee to submit comments. Note, that since this is at the DIS stage of the process these comments, unless really minor typos, typically will not have an impact on the 3rd revision of the standard but will probably have to wait til the next revision cycle of the standard as at DIS you can’t make any technical changes to the standard. This stage is fairly late in the process and so you aren’t typically allowed to make these types of changes based on how the process is structured in the ISO and IEC standards development process.
When is it anticipated this standard will be released?
The article goes on to say if things run smoothly you may be able to see the actual published standard by late 1st quarter 2015 or early 2nd quarter 2015. It is expected that there would be some type of transition period established for this standard and this may be impacted by things like the publication of ISO 9001 which this standard relies on, supporting the existing European Medical device Directives and the upcoming Medical Devices Regulations.
The article mentions that you can view a copy of the draft on the BSI National Standards Body website or you can buy a copy as noted in the article.
If you need additional support in the standards development process for a standard email Leo Eisner at , or call Leo at +1-(503)-244-6151 as he is a Convener for an IEC/ISO, EN and ANSI/AAMI standard for IEC/ISO 80601-2-58 on Lens Removal and Vitrectomy Equipment. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).