The Principles of Medical Device Decontamination

Legislation, Standards and Guidance

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What are Standards?

A standard is a technical document, drafted by recognised standards bodies, that seek to establish standardised specifications, requirements, specifications and practices. In an increasingly regulated environment, decontamination makes extensive use of these documents to allow practitioners and manufacturers to follow and hence claim conformity to these established criteria for the purposes of minimising errors across geographic or technical areas, helping to ensure alignment and common understanding.

Relationship of Standards to Law and Guidance

Standards are generally written as voluntary requirements, and hence are not intended directly to be mandatory. However, standards are often used as a route to compliance to requirements that may be mandatory and as such, standards have a very important role. The regulatory structure and requirements in different parts of the world clearly differ, but at a top-level perspective, there is much commonality. Since leaving Europe, the UK has its own national laws that are expected to diverge from European law as time progresses, however the same relationship of standards and legal requirements is similar throughout the world, with designated standards operating in a similar way to European harmonised standards. Certain European standards are harmonised, an approach where standards are deemed to provide a presumption of conformity to specific parts of European law, hence the use of harmonised European standards gives prescriptive detail as a route to comply to legal requirements. Practitioners and manufacturers within Europe may use the table in Annex Z i of one or more harmonised European standards (see European standards below) to show, within the limits of the scope of the harmonised standard, a presumption of conformity with the corresponding Essential Requirements of European Directive. This means that if this method is used, compliance with the Essential Principles or Conformity Assessment

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