EN 13795-2:2019

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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 . 12
A.2.2 Test method for evaluation of particle release . 12
A.2.3 Test method for evaluation of bursting strength in dry state . 13
A.2.4 Test method for evaluation of tensile strength in dry state . 13
A.2.5 Test method for evaluation of dry microbial penetration . 13
A.2.6 Test method for evaluation of biocompatibility . 13
A.3 Treatment of results . 13
Annex B (informative) Rationales . 15
B.1 General . 15
B.2 Cleanliness – microbial . 15
B.3 Particle release . 15
B.4 Bursting strength – dry . 16
B.5 Tensile strength – dry . 16
B.6 Resistance to microbial penetration – dry . 16
B.7 Labelling . 17
B.8 Treatment of results . 17
B.9 Flammability . 18
B.10 Electrostatic discharge . 18
Annex C (informative) Environmental aspects . 19
Annex D (informative) Guidance to users for selecting products . 20
D.1 General . 20
D.2 Performance levels . 20
D.3 Functional design aspects . 20
D.3.1 Size . 20
D.3.2 Accessories . 20
D.4 Comfort . 21
D.4.1 General . 21
D.4.2 Clean air suits . 21
D.4.3 Practical trials . 21
Annex E (informative) Functional design . 22
E.1 General . 22
E.2 Test method for measuring source strength . 22
E.2.1 Dispersal chamber . 22
E.2.2 Operating room . 23
E.2.3 Measuring bacteria carrying airborne particles . 23
E.2.4 Source strength . 23
E.3 Use of source strength measurements . 24
Annex ZA (informative) Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [1993 OJ L 169] aimed to be covered . 26
Bibliography . 27

European foreword
This document (EN 13795-2:2019) has been prepared by Technical Committee CEN/TC 205 “Non-
active medical devices”, the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by October 2019, and conflicting national standards shall
be withdrawn at the latest by October 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Together with EN 13795-1:2019, this document supersedes EN 13795:2011+A1:2013.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
EN 13795 consists of the following parts, under the general title Surgical clothing and drapes —
Requirements and test methods:
— Part 1: Surgical drapes and gowns
— Part 2: Clean air suits
The following changes have been introduced:
a) Restriction to the product ‘clean-air suit’ in this Part of the EN 13795 standard series (for surgical
drapes and gowns see EN 13795-1);
b) Alignment of the Standard title and the Scope;
c) Revision of the Normative references and the Bibliography;
d) Alignment of the Clause ‘Terms and definitions’;
e) Revision of the performance requirements in Table 1;
f) Movement of former Clause 5 ‘Testing’ to A.1 and editorial alignment;
g) Revision of Clause ‘Manufacturing and processing requirements‘ by adding of documentary
requirements and a section for the introduction of a QM system;
h) Enhancement and improved structuring of Clause ‘Information to be supplied by the manufacturer
or processor’;
i) Deletion of the former Annex A ‘Details of significant changes between this document and the
previous edition’;
j) Complete revision and extension of Annex A ‘Testing’ (formerly Annex B ‘Test methods’);
k) Inclusion of a new Annex B ‘Rationales’ which provides precise reasons for the essential
requirements of this document and which is intended for users aware of the subject of this
document, but who did not join whose development;
l) Deletion of the former Annex C ‘Prevention of infection in the operating room‘;
m) Inclusion of a new Annex C ‘Environmental aspects’;
n) Inclusion of a new Annex D ‘Guidance to users for selecting products‘;
o) Inclusion of a new Annex E 'Functional design';
p) Revision of Annex ZA on the relationship to the Medical Device Directive (93/42/EEC);
q) Complete editorial revision.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: 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 the United Kingdom.
Introduction
Clean air suits are used to minimize the spread of infective agents to patients’ surgical sites and
equipment, through prevention of dispersal of bacteria-carrying skin scales from t
...