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FprEN 13795-2

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits FprEN 13795-2

Publication date:   Aug 31, 2023

General information

50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks   Oct 3, 2024

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.140   Hospital equipment

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Scope

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.

Related legislation

Legislation related to this standard

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Legislation 2017/745

Life cycle

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PUBLISHED
EN 13795-2:2019

NOW

IN_DEVELOPMENT
FprEN 13795-2
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Oct 3, 2024