BAS EN 13795-2:2020
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
General Information
Status: Published
No. of pages: 29
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 30.09.2020
Technical committee:
Directive:
93/42/EEC, Medical devices
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Abstract
This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable clean air suits used as medical devices for clinical staff, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.
Lifecycle
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Original document and degree of correspondence
- EN 13795-2:2019, identical