EN 13795-1:2019
(Main)Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
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 surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, 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 surgical drapes and gowns and sets performance requirements for these products.
EN 13795-1 does not cover requirements for resistance to penetration by laser radiation of products. Suitable test methods for resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810.
EN 13795-1 does not cover requirements for incise drapes or films.
EN 13795-1 does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment may cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this standard with respect to their use as surgical gowns and drapes.
Operationskleidung und -abdecktücher - Anforderungen und Prüfverfahren - Teil 1: Operationsabdecktücher und -mäntel
Dieses Dokument 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. Dieses Dokument gibt Aufschluss über die Eigenschaften von Einmal und Mehrweg Operationsmänteln und abdecktüchern zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte, 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 Operationsabdecktüchern und mänteln sowie die Anforderungen an diese Produkte fest.
Dieses Dokument befasst sich nicht mit Anforderungen an die Resistenz gegenüber der Penetration von Laserstrahlung von Produkten. Geeignete Prüfverfahren für die Resistenz gegen die Penetration durch Laserstrahlung zusammen mit einer geeigneten Klassifizierung sind in EN ISO 11810 angegeben.
Dieses Dokument befasst sich nicht mit Anforderungen für Inzisionsstreifen oder folien.
Dieses Dokument befasst sich nicht mit Anforderungen für antimikrobielle Behandlungen für Operations-mäntel und abdecktücher. Antimikrobielle Behandlung kann zu Umweltrisiken wie Resistenz und Ver-schmutzung führen. Jedoch müssen antimikrobiell behandelte Operationsmäntel und abdecktücher die Anforderungen dieses Dokuments bezüglich deren Verwendung als Operationsmäntel und abdecktücher erfüllen.
Vêtements et champs chirurgicaux - Exigences et méthodes d’essai - Partie 1 : Champs et casaques chirurgicaux
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 champs chirurgicaux et des casaques chirurgicales, qu’ils soient à usage unique ou réutilisables, utilisés en tant que dispositifs médicaux pour les patients, le personnel médical et les équipements et destinés 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 champs et casaques chirurgicaux et établit des exigences de performance pour ces produits.
La prEN 13795-1 n’aborde pas les exigences relatives à la résistance des produits à la pénétration par rayonnement laser. Des méthodes d’essai appropriées à la résistance à la pénétration par rayonnement laser ainsi qu’un système de classification adéquat sont donnés dans l’EN ISO 11810.
La prEN 13795-1 n’aborde pas les exigences relatives aux champs et aux films à inciser.
La prEN 13795-1 n’aborde pas les exigences relatives aux traitements antimicrobiens pour casaques et champs chirurgicaux. Le traitement antimicrobien peut présenter un risque pour l’environnement, notamment une résistance et une pollution environnementales. Cependant, les casaques et champs chirurgicaux soumis à un traitement antimicrobien sont couverts par le domaine d’application de la présente norme en ce qui concerne leur utilisation comme casaques et champs chirurgicaux.
Operacijska oblačila in pokrivala - Zahteve in preskusne metode - 1. del: Operacijska pokrivala in plašči
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 operacijskih plaščev in pokrival za enkratno in večkratno uporabo, ki se uporabljajo kot medicinski pripomočki za paciente, zdravstveno osebje in opremo 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 operacijskih pokrival in plaščev ter čistih oblačil in določa zahteve glede zmogljivosti teh proizvodov.
Standard EN 13795-1 ne zajema zahtev za odpornost proizvodov na penetracijo z laserskim sevanjem. Ustrezne preskusne metode za odpornost na penetracijo z laserskim sevanjem skupaj z ustreznim sistemom razvrščanja so podane v standardu EN ISO 11810.
Standard EN 13795-1 ne zajema zahtev za incizijska pokrivala ali folije.
Standard EN 13795-1 ne zajema zahtev za protimikrobne obdelave za operacijske plašče in pokrivala. Protimikrobna obdelava lahko povzroči tveganja za okolje, kot npr. odpornost in onesnaženost. Vendar pa protimikrobno obdelani operacijski plašči in pokrivala spadajo na področje uporabe tega standarda glede na to, da se uporabljajo kot operacijski plašči in pokrivala.
General Information
Relations
Standards Content (Sample)
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.
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.
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
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
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 ‘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’ which consisted of 3 parts;
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 have not participated in its development;
l) Deletion of the former Annex C ‘Prevention of infection in the operating room‘;
m) Revision and extension of Annex C (formerly Annex D) ‘Information on further characteristics‘; e.g.
inclusion of a Clause on ‚ Flammability‘ and ‘Electrostatic discharge’;
n) Inclusion of a new Annex D ‘Environmental aspects’;
o) Inclusion of a new Annex E ‘Guidance to users for selecting products‘;
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,
...
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