SIST EN 13795-1:2025
(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 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 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 document specifies test methods for evaluating the identified characteristics of surgical drapes and gowns and sets performance requirements for these products.
This document does not include information on resistance to penetration by laser radiation of products.
NOTE If resistance to penetration by laser radiation is claimed for surgical drapes, suitable test methods together with an appropriate classification system are given in EN ISO 11810.
This document does not cover requirements for incision drapes or films.
This document does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment can cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this document 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 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-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 Beurteilung der bestimmten Eigenschaften von Operationsabdecktüchern und mänteln sowie die Anforderungen an diese Produkte fest.
Dieses Dokument enthält keine Informationen über die Beständigkeit von Produkten gegenüber der Durchdringung durch Laserstrahlung.
ANMERKUNG Wenn für Operationsabdecktücher Beständigkeit gegenüber der Durchdringung durch Laserstrahlung beansprucht wird, können EN ISO 11810 geeignete Prüfverfahren zusammen mit einem geeigneten Klassifizierungssystem entnommen werden.
Dieses Dokument befasst sich nicht mit Anforderungen für Inzisionsstreifen oder folien.
Dieses Dokument befasst sich nicht mit Anforderungen für antimikrobielle Behandlungen für Operationsmäntel und abdecktücher. Antimikrobielle Behandlung kann zu Umweltrisiken wie Resistenz und Verschmutzung führen. Dennoch 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
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 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.
Le présent document 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.
Le présent document n’inclut pas d’informations relatives à la résistance des produits à la pénétration par rayonnement laser.
NOTE Si la résistance à la pénétration par rayonnement laser est revendiquée pour les champs chirurgicaux, des méthodes d’essai appropriées ainsi qu’un système de classification adéquat sont indiqués dans l’EN ISO 11810.
Le présent document n’aborde pas les exigences relatives aux champs et aux films à inciser.
Le présent document 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 du présent document 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
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2025
Nadomešča:
SIST EN 13795-1:2019
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 13795-1:2025
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
January 2025
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 13795-1:2019
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 29 December 2024.
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, 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13795-1:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Performance requirements . 9
5 Manufacturing and processing requirements and documentation . 11
6 Information to be supplied with the product . 12
6.1 Information to be supplied to the user . 12
6.2 Information to be supplied to the processor . 12
Annex A (normative) Testing . 13
A.1 General . 13
A.2 Test methods and conformance . 13
A.3 Treatment of results . 15
Annex B (informative) Rationales . 17
B.1 General . 17
B.2 Microbial cleanliness . 17
B.3 Particle release . 17
B.4 Resistance to liquid penetration . 18
B.5 Bursting strength – dry and wet . 19
B.6 Tensile strength – dry and wet . 19
B.7 Resistance to microbial penetration – dry . 20
B.8 Resistance to microbial penetration – wet . 21
B.9 Labelling . 21
B.10 Treatment of results . 22
Annex C (informative) Information on further characteristics . 23
C.1 Comfort . 23
C.2 Adhesion for fixation for the purpose of wound isolation . 23
C.3 Liquid control . 24
C.4 Flammability . 24
C.5 Electrostatic discharge . 24
Annex D (informative) Environmental impact . 25
Annex E (informative) Guidance to users for selecting products . 27
E.1 Performance levels . 27
E.2 Functional design. 27
E.3 Practical trials . 29
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . 30
Bibliography . 32
European foreword
This document (EN 13795-1:2025) 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 July 2025, and conflicting national standards shall be
withdrawn at the latest by July 2025.
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.
This document supersedes EN 13795-1:2019.
a) clarification of testing specifications and reporting of results;
b) preparation of samples for testing of bursting strength in the wet state according to the test method
standard EN ISO 13938-1:2019 (i.e. not any longer according to EN 29073-3:1992 as in the previous
version);
c) expansion of former Annex D “Environmental aspects” to include considerations regarding
environmental impact and circular economy (now Annex D “Environmental impact”);
d) alignment with Regulation (EU) 2017/745 (including updated Annex ZA);
e) update of normative references and bibliography.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, 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.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
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, 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 the United
Kingdom.
Introduction
The transmission of infective agents during invasive surgical procedures can occur in several ways (see
informative Annex B).
Surgical drapes, including the intended use as a sterile field, and surgical gowns are used to minimize the
spread of infective agents to and from patients’ operating wounds, thereby helping to prevent post-
operative wound infections (see Annex B).
The performance required of coverings for patients, clinical staff and equipment varies with, for example,
the type and duration of the procedure, the degree of wetness of the operation field, the degree of
mechanical stress on the materials and the susceptibility of the patient to infection.
The use of surgical gowns with resistance to the penetration of liquids can also diminish the risk to the
operating staff from infective agents carried in blood or body fluids.
This document is intended to assist the communication between manufacturers and third parties with
regard to material or product characteristics and performance requirements.
Therefore, Annex B provides comprehensive information on characteristics, measurement of
performance and performance requirements. Annex C provides information on characteristics regarded
relevant in context with surgical gowns and drapes, however but not covered normatively (i.e. without
applicable performance requirements). Annex D includes considerations regarding environmental
impact and circular economy. Annex E explains the concept of performance levels and provides guidance
to users for selecting products.
This document focuses on General Safety and Performance Requirements (GSPR) arising from the
Medical Device Regulation (EU) 2017/745, which are applicable to surgical drapes and gowns. The
requirements and guidance in this document are expected to be of help to manufacturers and users when
designing, processing, assessing and selecting products. It is the intention of this document to ensure the
same level of safety from single-use and reusable surgical clothing and drapes throughout their useful
life.
Surgical gowns are used to minimize the transmission of infective agents between patients and clinical
staff during surgical and other invasive procedures. Hereby, surgical gowns contribute to the clinical
condition and the safety of patients as well as to the safety and health of users following up General Safety
and Performance Requirements (GSPR) of Regulation (EU) 2017/745 on Medical Devices. This document
addresses the same level of protection for patients and users (i.e. the surgical team) by not differentiating
the performance requirements for surgical gowns respectively. However, this document does not
formally address any Essential Health and Safety Requirements of Regulation (EU) 2016/425 on Personal
Protective Equipment and does not provide specific guidance for surgical gowns intended by the
manufacturer for dual use as medical device and personal protective equipment.
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