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CEN

prEN 13795-2

(Main)

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

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

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.

Operationskleidung und -abdecktücher - Anforderungen und Prüfverfahren - Teil 2: Rein-Luft-Kleidung

Dieses Dokument legt die Informationen fest, die Anwendern und Drittprüfern zusätzlich zu der üblichen Kennzeichnung von Medizinprodukten (siehe EN ISO 20417 und EN ISO 15223 1) bezüglich der Herstellungs- und Aufbereitungsanforderungen bereitzustellen sind.
Dieses Dokument gibt Aufschluss über die Eigenschaften von Einmal- und Mehrweg-Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Klinikpersonal, zum Schutz vor Übertragung infektiöser Agenzien zwischen Klinikpersonal und Patienten während operativer und anderer invasiver Eingriffe.
Dieses Dokument legt Prüfverfahren zur Bewertung der bestimmten Eigenschaften von Rein-Luft-Kleidung sowie die Anforderungen an diese Produkte fest.

Vêtements et champs chirurgicaux - Exigences et méthodes d'essai - Partie 2 : Tenues de bloc

Le présent document spécifie les informations à fournir aux utilisateurs et aux vérificateurs tiers en plus de l’étiquetage usuel des dispositifs médicaux (voir l’EN ISO 20417 et l’EN ISO 15223 1) concernant les exigences de fabrication et de traitement.
Le présent document fournit des informations sur les caractéristiques des tenues de bloc, qu’elles soient à usage unique ou réutilisables, utilisées en tant que dispositifs médicaux pour le personnel médical et destinées à empêcher la transmission d’agents infectieux entre le personnel chirurgical et les patients au cours des interventions chirurgicales et autres interventions invasives.
Le présent document spécifie les méthodes d’essai permettant d’évaluer les caractéristiques identifiées des tenues de bloc et établit les exigences de performance pour ces produits.

Operacijska oblačila in pokrivala - Zahteve in preskusne metode - 2. del: Čista oblačila

General Information

Status
Not Published
Publication Date
02-Feb-2025
ICS
11.140 - Hospital equipment
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205/WG 14 - Surgical clothing and drapes used as medical devices in health care facilities - Performance requirements and test methods
Current Stage
4060 - Closure of enquiry - Enquiry
Start Date
23-Nov-2023
Due Date
10-Mar-2023
Completion Date
23-Nov-2023
Directive
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
Mandate
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
oSIST prEN 13795-2:2023 - Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

Relations

Revises
EN 13795-2:2019 - Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
Effective Date
18-Jan-2023

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Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN 13795-2:2023
01-november-2023
Nadomešča:
SIST EN 13795-2:2019
Operacijska oblačila in pokrivala - Zahteve in preskusne metode - 2. del: Čista
oblačila
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
Operationskleidung und -abdecktücher - Anforderungen und Prüfverfahren - Teil 2: Rein-
Luft-Kleidung
Vêtements et champs chirurgicaux - Exigences et méthodes d'essai - Partie 2 : Tenues
de bloc
Ta slovenski standard je istoveten z: prEN 13795-2
ICS:
11.140 Oprema bolnišnic Hospital equipment
oSIST prEN 13795-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN 13795-2:2023

---------------------- Page: 2 ----------------------
oSIST prEN 13795-2:2023


DRAFT
EUROPEAN STANDARD
prEN 13795-2
NORME EUROPÉENNE

EUROPÄISCHE NORM

August 2023
ICS 11.140 Will supersede EN 13795-2:2019
English Version

Surgical clothing and drapes - Requirements and test
methods - Part 2: Clean air suits
Vêtements et champs chirurgicaux - Exigences et Operationskleidung und -abdecktücher -
méthodes d'essai - Partie 2 : Tenues de bloc Anforderungen und Prüfverfahren - Teil 2: Rein-Luft-
Kleidung
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 205.

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 13795-2:2023 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN 13795-2:2023
prEN 13795-2:2023 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Performance requirements . 8
5 Manufacturing and processing requirements and documentation . 9
6 Information to be supplied with the product . 9
6.1 Information to be supplied to the user . 9
6.2 Information to be supplied to the processor . 9
Annex A (normative) Testing . 10
Annex B (informative) Rationales .
...

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