DIN Standards Committee Health Technologies
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
Abstract
This document specifies information to be supplied to users and third-party verifiers in addition to the usual labelling of medical devices (see EN ISO 20417 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.
Begin
2022-01-21
WI
00205383
Planned document number
FprEN 13795-2
Responsible national committee
NA 176-04-07 AA - Surgical textiles
Responsible european committee
CEN/TC 205/WG 14 - Surgical clothing and drapes, and medical face masks
draft standard
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
2023-08
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Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
2024-10
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previous edition(s)
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
2019-04
