IHEEM 2022 AE CONFERENCE
Brian Kirk explained both what standards were, and where they originated, but also why we need them.
standard, and could then supply a single product to the whole of the European market.” He added: “That has changed with Brexit; I’ll talk a little about that later.” Another rationale for standards was to
achieve ‘a universal approach to achieving a given objective’. Again, using the example of a sterile product, Brian Kirk explained that the decontamination sector had a series of standards telling personnel employed within it how to validate and operate processes which deliver sterile products. He told the audience: “It might also be to achieve regulatory compliance – I have already mentioned the link between the harmonised standards, which support that regulation.” Standards, he explained, also had an important safety aspect. He elaborated: “We all know the problems that arose around the supply of PPE during the pandemic. PPE is covered by certain European standards in relation to its filtration capabilities.”
Measuring methods in history Taking ‘a light-hearted look at how today’s standards had evolved’, Brian Kirk took the example of historical measurements of length, explaining that, in the past, these typically related to the human body; examples being the ‘ell’ or cubit, the ‘foot’, the ‘span’, and the ‘yard’. He said: “All of these relate to the human body, but of course humans are not standardised. So, look at the list, and you can see that the definition of the ‘ell’ in the early days of standardisation differed from country to country. So, in Egypt, the royal ell was 0.52 metres, in Italy 0.54, and in the Vatican, 0.75.” As things evolved, he explained, physical standards, such as iron rods, were fixed on public buildings in marketplaces where trading was taking place. Here the speaker showed a series of photos of standards for length, where – he explained – ‘people used those standards to make sure they got a yard of cloth if that is what they wanted’. Brian Kirk continued: “It was when we
started to define the metre that we started seeing international cooperation and standardisation, with the metre defined by the French Academy of Sciences in
42 Health Estate Journal August 2022
Measures of length – such as the ‘ell’ – have typically related to the human body, but the ‘ell’ varied in different countries.
1799 as the length between two marks on a platinum-iridium bar.” He added: “While this represented a characteristic of the Earth, the Earth was changing, so the standard also changed over a very long period. They later changed the definition of a metre to relate it to the speed of light – a constant; thus a metre is now defined in terms of the distance travelled in a fraction of a second by a photon of light.”
Standardisation and regulation Brian Kirk turned here to how standardisation relates to regulation, explaining that before the UK left the EU, the latter had produced Directives – ‘basically frameworks of laws’ that were enacted in local legislation; the UK, for example, had the Medical Device Regulation. Supporting that legislation are a series of harmonised European standards – ‘harmonised’ in that certain clauses within them relate to conformity with part of the regulations. He added: “So, if you met the standard, you could tick the boxes to confirm that you met certain elements of the Regulation.” Linked to this were what he dubbed ‘the cookbooks’ – ‘the recipes on how you can enact those clauses in the standard locally’. “So, for example,” Brian Kirk continued, “we have the Health Technical Memoranda, which tell you exactly how to undertake a test to meet a clause in a standard specification.” There were, however, ‘other complicating factors’, with all the national bodies ‘having their own spin’ on how they want to see, for example, decontamination, undertaken. He explained: “So, we have things like NICE, CQC, the notified bodies, Healthwatch, and, very importantly, ACDP, which deals with things like vCJD. They will all have an opinion on whether the standard we’re going to adopt is appropriate for what’s happening in the UK – which is where you start to see some differences between our local guidance and what’s specified in some of these standards.”
Brian Kirk said Brexit had ‘changed
everything’. He elaborated: “We’re not really certain how the UK Government is going to relate itself to the link between
regulation and the standards we have always adopted as part of our EU membership.”
Standards hierarchy Here, showing a diagram incorporating a triangle, the speaker said he would focus on ‘standards hierarchy’. He said: “The first level, at the top, is the International Organization for Standardization, which covers the whole world. All of the major industrial countries participate in ISO standards development. Below the ISO are regional standards development bodies – for example the CEN organisation within Europe, and then, below these, are our long-standing national standards bodies – for example, BSI.” Looking at these bodies’ structure, Brian Kirk explained that the International Organization for Standardization, or ‘ISO’, comprises a series of Technical Committees, sub-divided into Project or Working Groups developing individual or groups of standards. He said: “The Technical Committees are populated by delegates nominated from participating countries, and the Working Groups by subject matter experts, usually nominated from the national standards bodies.” Brian Kirk explained that in ‘his field’ – ISO TC/198: The sterilization of healthcare products – there were 16 different Working Groups developing standards in the individual technical areas shown in a list on his next slide – such as WG1: Industrial ethylene oxide sterilization; WG4: Biological indicators, and WG13: Washer- disinfectors.
CEN’s role His next focus was CEN – the European standards organisation, which covers most of the European countries, and has a similar structure to ISO. Technical Committees are sub-divided into Project or Working Groups, and the Committees populated by delegates from individual countries, and the Working Groups by subject matter experts, ‘again, usually nominated by their standards bodies’. Returning to his own field, he said: “Look at CEN/TC 102: Sterilizers for
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