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| THE EUROPEAN STANDARD (EN13795) |
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In 1998, the European Committee for Standardisation (Comité Européen de Normalisation or CEN) and its Technical Committee 205- Non-active Medical Devices received a mandate from the European Commission to establish a new working group, WG 14 for the development of a harmonized European standard EN13795 for surgical gowns, drapes and clean air suits.
The scope of the new standard development has been defined as follows:
‘This Standard specifies information to be supplied to users and third party verifiers, in addition to the usual labeling of Medical Devices, concerning manufacturing and processing requirements.’ It ‘gives general guidance on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as Medical Devices for patients, clinical staff and equipment. It is intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures.’
European Standard EN 13795 will consist of 3 parts:
Part 1: General requirements for manufacturers, processors und products (adopted 2nd February 2002)
Part 2: Test methods
Part 3: Performance Requirements and Performance Level
The EN13795 will provide a useful tool to comply with the regulations of the European Council Directive 93/42/ECC that is often referred to as Medical Device Directive or MDD.
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