SIST EN 13795-1:2019

Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

Operacijska oblačila in pokrivala - Zahteve in preskusne metode - 1. del: Operacijska pokrivala in plašči

General Information

• Status: Published
• Technical Committee: COVID 19 - COVID 19 - ISO
• Directive: standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK

Standards Content (Sample)

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SLOVENSKI STANDARD
01-julij-2019
Nadomešča:
SIST EN 13795:2011+A1:2013
Operacijska oblačila in pokrivala - Zahteve in preskusne metode - 1. del:
Operacijska pokrivala in plašči
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes
and gowns
Operationskleidung und -abdecktücher - Anforderungen und Prüfverfahren - Teil 1:
Operationsabdecktücher und -mäntel
Vêtements et champs chirurgicaux - Exigences et méthodes d’essai - Partie 1 : Champs
et casaques chirurgicaux
Ta slovenski standard je istoveten z: EN 13795-1:2019
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.

Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

EN 13795-1
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 1: Surgical drapes and gowns
Vêtements et champs chirurgicaux - Exigences et Operationskleidung und -abdecktücher -
méthodes d'essai - Partie 1 : Champs et casaques Anforderungen und Prüfverfahren - Teil 1:
chirurgicaux Operationsabdecktücher und -mäntel
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 13795-1:2019 E
worldwide for CEN national Members.

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN 13795-1:2019 (E)
Contents Page
European foreword . 4
Introduction . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 Performance requirements . 11
5 Manufacturing and processing requirements and documentation . 13
6 Information to be supplied with the product . 13
6.1 Information to be supplied to the user . 13
6.2 Information to be supplied to the processor . 14
Annex A (normative) Testing . 15
A.1 General . 15
A.2 Test methods and conformance . 15
A.2.1 Test method for evaluation of cleanliness microbial/bioburden . 15
A.2.2 Test method for evaluation of particle release . 16
A.2.3 Test method for evaluation of liquid penetration . 16
A.2.4 Test method for evaluation of bursting strength in dry and wet state . 16
A.2.5 Test method for evaluation of tensile strength in dry and wet state . 17
A.2.6 Test method for evaluation of dry microbial penetration . 17
A.2.7 Test method for evaluation of wet microbial penetration . 17
A.2.8 Test method for evaluation of biocompatibility . 17
A.3 Treatment of results . 18
Annex B (informative) Rationales . 19
B.1 General . 19
B.2 Cleanliness – microbial . 19
B.3 Particle release . 19
B.4 Resistance to liquid penetration . 20
B.5 Bursting strength – dry and wet . 21
B.6 Tensile strength – dry and wet . 21
B.7 Resistance to microbial penetration – dry . 21
B.8 Resistance to microbial penetration – wet . 23
B.9 Labelling . 23
B.10 Treatment of results . 24
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
EN 13795-1:2019 (E)
Annex C (informative) Information on further characteristics . 25
C.1 Comfort . 25
C.2 Adhesion for fixation for the purpose of wound isolation . 25
C.3 Liquid control . 25
C.4 Flammability . 26
C.5 Electrostatic discharge . 26
Annex D (informative) Environmental aspects . 27
Annex E (informative) Guidance to users for selecting products . 28
E.1 Performance levels . 28
E.2 Functional design. 28
E.2.1 General . 28
E.2.2 Critical and less critical areas . 28
E.2.3 Size . 29
E.2.4 Accessories . 29
E.2.5 Comfort . 29
E.2.5.1 General . 29
E.2.5.2 Surgical gowns . 29
E.2.5.3 Surgical drapes . 30
E.3 Practical trials . 30
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 . 31
Bibliography . 32

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
EN 13795-1:2019 (E)
European foreword
This document (EN 13795-1:2019) 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 13795-2:2019, 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) The product ‘clean-air suit’ has been moved to Part 2 of the EN 13795 standard series because of
distinctive requirements and test methods;
b) Alignment of the document title and the Scope;
c) Revision of the Normative references and the Bibliography;
d) Alignment of the Clause ‘Terms and definitions’;
e) Review of the performance requirements in Table 1 and Table 2 especially with regard to
‘Cleanliness - Particulate matter’ and ‘Linting’, which have been combined as ‘Particle release;
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 ‘In
...