EN 13795-1:2019

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

• Status: Published
• Publication Date: 02-Apr-2019
• Withdrawal Date: 30-Oct-2019
• ICS: 11.140 - Hospital equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 14 - Surgical clothing and drapes used as medical devices in health care facilities - Performance requirements and test methods
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 03-Apr-2019
• Due Date: 03-Jan-2019
• Completion Date: 03-Apr-2019
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 13795-1:2019 - Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

Relations

• Replaces: EN 13795:2011+A1:2013 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
• Effective Date: 08-Jun-2022
• Revised: prEN 13795-1 - Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
• Effective Date: 18-Jan-2023
• Revised: prEN 14683 - Medical face masks - Requirements and test methods
• Effective Date: 09-Feb-2022
• Revised: EN 13795:2011 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
• Effective Date: 14-Dec-2011

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 13795-1:2019
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
SIST EN 13795-1:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 13795-1:2019

---------------------- Page: 2 ----------------------

SIST EN 13795-1:2019


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.

---------------------- Page: 3 ----------------------

SIST EN 13795-1:2019
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 .
...