SIST EN 13795-2:2025
(Main)Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
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 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 document 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
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-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.
Dieses Dokument 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
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 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.
Le présent document 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
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2025
Nadomešča:
SIST EN 13795-2:2019
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 13795-2:2025
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
January 2025
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 13795-2:2019
English Version
Surgical clothing and drapes - Requirements and test
methods - Part 2: Clean air suits
Vêtements et champs chirurgicaux - Exigences et Operationskleidung 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 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 13795-2:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 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 . 11
A.2 Test methods and conformance . 11
A.3 Treatment of results . 13
Annex B (informative) Rationales . 14
B.1 General . 14
B.2 Microbial cleanliness . 14
B.3 Particle release . 14
B.4 Bursting strength – dry . 15
B.5 Tensile strength – dry . 15
B.6 Resistance to microbial penetration – dry . 15
B.7 Labelling . 16
B.8 Treatment of results . 16
B.9 Flammability . 17
B.10 Electrostatic discharge . 17
Annex C (informative) Environmental impact . 18
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.4 Comfort . 21
Annex E (informative) Functional design . 22
E.1 General . 22
E.2 Test method for measuring source strength . 22
E.3 Use of source strength measurements . 24
Annex ZA (informative) Relationship between this European standard and General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 26
Bibliography . 28
European foreword
This document (EN 13795-2:2025) 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 13795-2:2019.
a) clarification of testing specifications and reporting of results;
b) expansion of Annex C (formerly read “Environmental aspects”) to include considerations regarding
environmental impact and circular economy (now Annex C “Environmental impact”);
c) alignment with Regulation (EU) 2017/745 (including updated Annex ZA);
d) 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
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 the operating room
staff, thereby helping to prevent post-operative surgical site infections.
The performance required of working clothes for clinical staff varies with, for example, the type and
duration of the procedure, and the susceptibility of the patient to infection. In infection-prone invasive
operations, a clean air suit can contribute to reduction of infection risks, in conjunction with ventilation
and correct working methods.
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 includes considerations regarding environmental
impact and circular economy. Annex D explains the concept of performance levels and provides guidance
to users for selecting products. Annex E gives information on the impact of the design of clean air suits
and the source strength concept as an evaluation means for the impact of the entire clothing (including
clean air suits) on particle release.
This document focuses on General Safety and Performance Requirements (GSPR) arising from the
Medical Device Regulation (EU) 2017/745, which are applicable to clean air suits. 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 clean air suits throughout their useful life.
1 Scope
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 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 document specifies test methods for evaluating the identified characteristics of clean air suits and
sets performance requirements for these products.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN ISO 139:2005, Textiles — Standard atmospheres for conditioning and testing (ISO 139:2005)
EN ISO 9073-3:2023, Nonwovens — Test methods — Part 3: Determination of tensile strength and
elongation at break using the strip method (ISO 9073-3:2023)
EN ISO 9073-10:2004, Textiles — Test methods for nonwovens — Part 10: Lint and other particles
generation in the dry state (ISO 9073-10:2003)
EN ISO 10993-1:2020, Biological evaluation of medical devices — Part 1: Evaluation and testing within a
risk management process (ISO 10993-1:2018, including corrected version 2018-10)
EN ISO 11737-
...
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