NEN-EN 13795-2:2019 en

Current standard
29 Pages
Publication date 2019-04-01
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Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
NEN-EN 13795-2 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 document 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 document specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.
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Date of withdrawal
CEN/TC 205/WG 14
ICS code
11.140 Hospital Equipment
Related to
EN 13795-2:2019, IDT
Health services - Hospitals - Surgical coverings - Medical devices - Regulations - Performance - Protective clothing - Hospital equipment

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