FprEN 13795-1
(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-november-2023
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: prEN 13795-1
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
EUROPEAN STANDARD
prEN 13795-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2023
ICS 11.140 Will supersede 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 draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 205.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 13795-1:2023 E
worldwide for CEN national Members.
prEN 13795-1:2023 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 6
4 Performance requirements . 8
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
Annex B (informative) Rationales . 17
Annex C (informative) Information on further characteristics . 23
Annex D (informative) Environmental impact . 25
Annex E (informative) Guidance to users for selecting products . 27
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
prEN 13795-1:2023 (E)
European foreword
This document (prEN 13795-1:2023) has been prepared by Technical Committee CEN/TC 205 “Non-
active medical devices”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 13795-1:2019.
prEN 13795-1:2023 includes the following significant technical changes with respect to
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 to 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
prEN 13795-1:2023 (E)
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 clarifies that this document does not include
environmental provisions. Annex D 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 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.
prEN 13795-1:2023 (E)
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 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.
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 +
Amd. 1:2011)
EN ISO 811:2018, Textiles - Determination of resistance to water penetration - Hydrostatic pressure test
(ISO 811:2018)
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 11737-1:2018, Sterilization of medical devices — Microbiological methods — Part 1:
Determination of a population of microorganisms on products (ISO 11737-1:2018)
Impacted by EN ISO 139:2005/A1:2011
Impacted by EN ISO 11737-1:2018/A1:2021
prEN 13795-1:2023 (E)
EN ISO 13938-1:2019, Textiles - Bursting properties of fabrics - Part 1: Hydraulic method for determination
of bursting strength and bursting distension (ISO 13938-1:2019)
EN ISO 22610:2006, Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical
staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO
22610:2006)
EN ISO 22612:2005, Clothing for protection against infectious agents - Test method for resistance to dry
microbial penetration (ISO 22612:2005)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
3.1
colony forming unit
CFU
unit by which the culturable number of microorganisms is expressed
Note 1 to entry: The culturable number is the number of microorganisms, single cells or aggregates, able to form
colonies on a solid nutrient medium.
3.2
cleanliness
freedom
...
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