The Principles of Medical Device Decontamination

European Union (OJEU), compliance with certain clauses of the standard provide a presumption of conformity with corresponding legal requirements. Harmonised standards are not easy to recognise – they will both be cited in the OJEU and will have an Annex Z that includes a table which cross references applicable clauses of the legal requirements with clauses of the standard. Hence these standards can be used as a way of demonstrating compliance with legal requirements that are possibly written in very broad or open terms. When EN standards are nationally implemented, they are numbered with the EU member state NSO prefix, so for example in Germany, an EN standard would be prefixed DIN EN followed by the EN number. It is increasingly common that ISO standards are adopted under the Vienna Agreement, hence ISO documents would be labelled as DIN EN ISO followed by the ISO number in Germany.

How to read and understand a Standard

Standards are written using very deliberate language; they are not meant to be works of literary brilliance, so it is not uncommon to see, for example, repetitive text or strange sentence construction, which is used to ensure that there is no ambiguity in the requirements given. The language used in a standard depends upon the nature of the section; standards use the term ‘shall’ in order to show mandatory or normative requirements, for example, or ‘should’ to show guidance or optional informative text. If a product or service claims conformity to a standard, it must comply with every requirement in that standard i.e. a claim to conformity is an absolute. Partial conformity is not appropriate.

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