Controlling the Process: Legislation and Guidance Regulating the Decontamination of Medical Devices (Open LEARNING ZONE)

Controlling the Process: Legislation and Guidance Regulating the Decontamination of Medical Devices (Open LEARNING ZONE)

Medical Device Directives There are three European Directives which cover medical devices: general medical devices are covered by 93/42 (MHRA 1993), in vitro diagnostics by 98/79 (MHRA 1998) and active implantable medical devices by 90/385 (MHRA 1990). The activities of a sterile services unit is covered by the medical device directive MDD 93/42/EEC which was introduced into United Kingdom (UK) law under the Medical Device Regulations (HMSO 2003).

Controlling the Process: Legislation and Guidance Regulating the Decontamination of Medical Devices (Open LEARNING ZONE)



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