The Principles of Medical Device Decontamination

ISO standards are developed by the International Organization for Standardization (ISO). ISO is a network of over 160 national standards organisations (NSOs) with a Central Secretariat in Geneva, Switzerland. ISO is the world’s largest developer of voluntary international standards. International standards give state of the art specifications for products, services and good practice, helping to make industry more efficient and effective. Developed through global consensus, they help to break down barriers to international trade. The ISO NSOs can adopt standards as national standards, hence in the UK they would become prefixed as BS ISO followed by the ISO number, or as ANSI/AAMI/ISOs in the US, for example. There is no requirement for a NSO to adopt an ISO standard, and they can in addition be nationally modified, so if France does not like a particular requirement, for example, this could be deleted in the French (NF ISO) national implementation.

European Standards

EN standards are developed by CEN (European Committee for Standardization), based in Brussels, Belgium, and formed in 1975. European standards are also published by CENELEC (European Committee for Electrotechnical Standardization). ENs, like other standards, are voluntary standards, however increasingly support EU policies and legislation. Under European Law, a European standard has to be implemented into each EU state in an unaltered form and any conflicting national standards withdrawn. These standards can afford to be much more prescriptive than Directives or Regulations, and are generally deemed to be considered ‘best practice’. EU standards can either be ‘harmonised’ or not. The term ’harmonised’ is often misunderstood; this refers to harmonisation within legislation, against a specified directive or directives (as opposed to being ‘harmonised’ across all 27 EU member states plus the EFTA states – a requirement of any European standard). Harmonised standards provide a means of conforming to Essential Requirements or General Safety and Performance Requirements of specified legal requirements; once the standard has been cited in the Official Journal of the

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