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

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.

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

Diese Europäische Norm legt die Informationen fest, die dem Anwender und Prüfer (Dritte) zu liefern sind, zusätzlich zu der normalen Kennzeichnung von Medizinprodukten (siehe EN 1041 und EN ISO 15223 1) bezüglich Anforderungen an die Herstellung und Aufbereitung. Diese Europäische Norm 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. Diese Europäische Norm 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

La présente Norme européenne spécifie les informations à fournir aux utilisateurs et aux vérificateurs tiers en plus de l’étiquetage usuel des dispositifs médicaux (voir l’EN 1041 et l’EN ISO 15223-1) concernant les exigences de fabrication et de traitement. La présente norme européenne 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. La présente Norme européenne 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

Ta evropski standard določa informacije, ki jih je treba poleg običajnega označevanja medicinskih pripomočkov (glej standarda EN 1041 in EN ISO 15223-1) podati uporabnikom in tretjim strankam, ki izvajajo preverjanje, in sicer v zvezi z zahtevami za proizvodnjo in obdelovanje. Ta evropski standard podaja informacije o lastnostih čistih oblačil za enkratno in večkratno uporabo, ki se uporabljajo kot medicinski pripomočki za zdravstveno osebje ter so namenjeni za preprečevanje prenosa infekcijskih agentov med zdravstvenim osebjem in pacienti med kirurškimi in drugimi invazivnimi postopki. Ta evropski standard določa preskusne metode za ocenjevanje identificiranih lastnosti čistih oblačil in določa zahteve glede zmogljivosti teh proizvodov.

General Information

Status
Published
Publication Date
02-Apr-2019
Withdrawal Date
30-Oct-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
03-Apr-2019
Due Date
03-Jan-2019
Completion Date
03-Apr-2019

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 13795-2:2019
01-julij-2019
Nadomešča:
SIST EN 13795:2011+A1:2013
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: EN 13795-2:2019
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 13795-2:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 13795-2:2019

---------------------- Page: 2 ----------------------

SIST EN 13795-2:2019


EN 13795-2
EUROPEAN STANDARD

NORME EUROPÉENNE

April 2019
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 13795:2011+A1:2013
English Version

Surgical clothing and drapes - Requirements and test
methods - Part 2: Clean air suits
Vêtements et champs chirurgicaux - Exigences et Operationsbekleidung und -abdecktücher -
méthodes d'essai - Partie 2 : Tenues de bloc Anforderungen und Prüfverfahren - Teil 2: Rein-Luft-
Kleidung
This European Standard was approved by CEN on 24 October 2018.

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. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13795-2:2019 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN 13795-2:2019
EN 13795-2:2019 (E)
Contents Page
European foreword . 4
Introduction . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Performance requirements . 10
5 Manufacturing and processing requirements and documentation . 11
6 Information to be supplied with the product . 11
6.1 Information to be supplied to the user . 11
6.2 Information to be supplied to the processor . 11
Annex A (normative) Testing . 12
A.1 General . 12
A.2 Test methods and conformance . 12
A.2.1 Test method for evaluation of cleanliness microbial/bioburden .
...

SLOVENSKI STANDARD
oSIST prEN 13795-2:2017
01-september-2017
2SHUDFLMVNDREODþLODLQSRNULYDOD=DKWHYHLQSUHVNXVQHPHWRGHGHOýLVWD
REODþLOD
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
Operationsbekleidung 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 13795-2:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN 13795-2:2017

---------------------- Page: 2 ----------------------
oSIST prEN 13795-2:2017


DRAFT
EUROPEAN STANDARD
prEN 13795-2
NORME EUROPÉENNE

EUROPÄISCHE NORM

June 2017
ICS 11.140 Will supersede EN 13795:2011+A1:2013
English Version

Surgical clothing and drapes - Requirements and test
methods - Part 2: Clean air suits
Vêtements et champs chirurgicaux - Exigences et Operationsbekleidung 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 13795-2:2017 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN 13795-2:2017
prEN 13795-2:2017 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Performance requirements . 9
5 Manufacturing and processing requirements and documentation . 9
6 Information to be supplied with the product . 10
6.1 Information to be supplied to the user . 10
6.2 Information to be supplied to the processor . 10
Annex A (normative) Testing . 11
A.1 General .
...

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