IHEEM 2022 AE CONFERENCE
How standards and guidance and legislation inter-relate.
medical purposes, and you can see the six Working Groups that are active – covering areas ranging from packaging materials, to testing and requirements for washer- disinfectors.”
National standards bodies Brian Kirk explained that when people referred to national standards bodies, ‘these were probably the older bodies’. As he highlighted on a list, ‘nearly every developed nation has its own standards body’ – for example the UK has BSI, and America ANSI / AAMI. Committees were again populated by experts from academia, industry, regulatory bodies, user groups, and – with recent changes – individuals. So, any audience member could apply to a BSI committee for membership, submit their CV, prove they were a subject matter expert, and then join the BSI committee. Brian Kirk said: “If we look at BSI and its impact on CEN/TC 102 and ISO 198 standards work, it used to have two sub-committees – LBI 35, dealing with equipment, and CH198, dealing with processes. These have now been combined into a single Committee, CH198, which again, made it a more efficient process for the members.”
A ‘clear path to regulatory compliance’ While standards were voluntary, compliance with harmonised standards identified ‘a clear path to regulatory compliance’ – through Annex Z. ISO standards could, Brian Kirk explained, be adopted as national standards, co-exist with national standards on the same subject, and were subject to change. “So,” he said, “we could add a UK national annex describing differences between the way we want to implement the ISO, and the way the ISO specifies.” For EU member states, CEN standards
must be adopted as national standards unchanged, and any conflicting local standards withdrawn. Brexit had so far not altered this, although Brian Kirk conceded that it might in the future, because ‘the powers that be’ were seeking to show clear separations ‘between the way the
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The multi-stage process via which a new standard emerges.
Brian Kirk: “If you’re making a product, and following a certain standard, linked to a regulatory document, that’s a means of proving that you meet the regulatory requirements specified. Otherwise, it might be a specification for a given device, or a process, to achieve a desired end-point”
UK does things, and the way Europe does things’.
The lifecycle of a standard Brian Kirk’s next focus was the ‘lifecycle’ of a standard. He explained: “It all starts with an NWIP, or New Work Item Proposal, usually generated by the national standards body. So, BSI could submit a NWIP for the design of a racecourse, which starts its life as a working draft, and then goes to the ISO Working Group for consideration. Once the Group is happy with the structure and content, they will send it out for voting as a committee draft (CD (V)), for consideration by the national delegations worldwide. If the CD (V) is met favourably, it moves on to the ‘DIS’ (or Draft International Standard) stage, again going out for consultation to the various national bodies worldwide.” Next, Brian Kirk explained, after a comment period, subsequent resolution of any concerns, and when all were happy with it, it would go forward as an FDIS for a ‘yes’ or ‘no’ vote, with no technical comments allowed at this stage. If it then receives at least a 66% vote, it is published as an EN / ISO standard, and eventually becomes a BSI standard. The process then begins again, with a Five-Year review.
Getting involved
Nearing the close of his part of the presentation, Brian Kirk explained that those interested in becoming ‘part of the standards process’ could firstly do so by joining an institute like IHEEM – which would then nominate members of its Technical Groups to join the BSI Committee, or, alternatively, apply to BSI direct to join as a subject matter
expert. He said: “Once you are on a BSI committee, you can volunteer to become a member of the CEN or ISO committees, taking you into the international arena, where you will represent your subject matter expertise; you are not supposed to represent commercial interests within those international committees.”
The electrical arena Here Brian Kirk handed over to IHEEM Electrical Technical Platform Chair, Paul Harris FIHEEM, MIEE, MCIBSE, who he said would continue the presentation by looking at the evolution and development of standards based on his experience in the electrical arena. Paul Harris began: “Everything Brian said follows through for electrical, and where we are with the Electrical Technical Platform, and particularly BS 7671: 2018: Requirements for Electrical Installations. IET Wiring Regulations – to which IHEEM has been a major contributor for nineteen and a half years. Electrically, we have a slight variation in the format, because of the way BS 7671 is structured compared with other standards. It’s a 600+-page standard, with four sub-committees and a number of Working Groups.” Paul Harris went on to describe what he dubbed ‘a Hierarchy of work-related documents’, using a slide incorporating a triangle – at the top of which were the Electricity at Work Regulations 1999 (the ‘EAWR’). He said: “We then have the HSE interpretation of how to comply with the Regulations. While not quite an Approved Code of Practice, it is the nearest we have to one, and you should adhere to the HSE interpretation of how to comply with the EAWR.” He continued: “We then
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