The Principles of Medical Device Decontamination

practice found today, but when opportunities exist to re-think or justify a historical approach, an evidence-based or scientific rationale is increasingly required.

Types of Standards

There are two significant types of standards based on content; these are referred to as standards, consisting typically of what one would expect of a standard by way of requirements, plus technical reports or technical specifications. Typically standards consist of principally ‘normative’ text, text that is mandatory if compliance to the standard is claimed, and ‘informative’ text, used to explain or justify the normative parts of the document, or parts of the document that are optional or for guidance. Guidance documents may be described as standards, however guidance documents are written in a different style to performance standards; the whole text of guidance is written using terms such as ‘should’ and ‘may’ as opposed to ‘shall’, highlighting the optional nature of guidance documents. Guidance documents are, however, more prescriptive in terms of how they describe an action. Typically the expectation is that guidance documents underpin the normative requirements of a standard (see ‘Relationship of standards to law and guidance).

Vienna Agreement

In order to prevent duplication of work between European Committee for Standardization ii (CEN) and International Organization for Standardization iii (ISO), the agreement on technical cooperation between CEN and ISO of 1991 (Vienna Agreement), revised in 2001, was implemented. The latest revision (3.3) of the Vienna Agreement gives priority to international standardisation, and lends greater importance to ISO leadership than did the previous versions, although there is generally close liaison with CEN members during this process.

International Standards

ii For more detailed information of the European Committee for Standardization https:// www.cencenelec.eu/european-standardization/cen-and-cenelec/ iii For more detail on the International Standards Organization https://www.iso.org/about

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