EN 13795:2011
(Main)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
General Information
- Abstract
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 980 and EN 1041), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products.
EN 13795 does not cover requirements for flammability of products. Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810-1 and EN ISO 11810-2. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards.
- Status
- Withdrawn
- Publication Date
- 15-Mar-2011
- Withdrawal Date
- 05-Feb-2013
- Technical Committee
- CEN/TC 205 - Non-active medical devices
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 06-Feb-2013
- Completion Date
- 06-Feb-2013
Not Harmonized93/42/EEC - Medical devices
Relations
- Effective Date
- 08-Jun-2022
- Effective Date
- 15-Aug-2009
- Effective Date
- 15-Aug-2009
- Effective Date
- 19-Jan-2023
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 14-Dec-2011
- Effective Date
- 14-Dec-2011
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 13795:2011 is a standard published by the European Committee for Standardization (CEN). Its full title is "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". This standard covers: 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 980 and EN 1041), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products. EN 13795 does not cover requirements for flammability of products. Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810-1 and EN ISO 11810-2. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards.
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 980 and EN 1041), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products. EN 13795 does not cover requirements for flammability of products. Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810-1 and EN ISO 11810-2. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards.
EN 13795:2011 is classified under the following ICS (International Classification for Standards) categories: 11.140 - Hospital equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 13795:2011 has the following relationships with other standards: It is inter standard links to EN 13795-3:2006+A1:2009, EN 13795-2:2004+A1:2009, EN 13795-1:2002+A1:2009, EN 13795:2011+A1:2013, EN ISO 9073-3:2023, EN ISO 22612:2005, EN ISO 11737-1:2006, EN ISO 13938-1:2019, EN ISO 139:2005, EN ISO 9073-10:2004, EN ISO 811:2018, EN ISO 22610:2006, EN 13795-1:2019, EN 13795-2:2019, EN 13795-1:2002. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13795:2011 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 93/42/EEC; Standardization Mandates: M/295. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 13795:2011 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Allgemeine Anforderungen für Hersteller, Wiederaufbereiter und Produkte, Prüfverfahren und GebrauchsanforderungenChamps chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux pour les patients, le personnel et les equipments - Exigences générales pour les fabricants, les prestataires et les produits, methods de test, prescriptionsSurgical 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 levels11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 13795:2011SIST EN 13795:2011en,fr,de01-julij-2011SIST EN 13795:2011SLOVENSKI
STANDARDSIST EN 13795-3:2006+A1:2009SIST EN 13795-2:2005+A1:2009SIST EN 13795-1:2003+A1:20091DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13795
March 2011 ICS 11.140 Supersedes EN 13795-1:2002+A1:2009, EN 13795-2:2004+A1:2009, EN 13795-3:2006+A1:2009English Version
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
Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Exigences générales pour les fabricants, les prestataires et les produits, méthodes d'essai, exigences et niveaux de performance
Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Allgemeine Anforderungen für Hersteller, Wiederaufbereiter und Produkte, Prüfverfahren und Gebrauchsanforderungen This European Standard was approved by CEN on 5 February 2011.
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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13795:2011: ESIST EN 13795:2011
Details of significant changes between this European Standard and the previous edition . 13Annex B (normative)
Test methods . 15Annex C (informative)
Prevention of infection in the operating room . 17Annex D (informative)
Information on further characteristics . 18Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 20Bibliography . 22 SIST EN 13795:2011
EN 13795-3:2006+A1:2009. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. Annex A provides details of significant changes between this European Standard and the previous edition represented by the three parts mentioned above. According to the CEN/CENELEC Internal Regulations, the national standards organizations 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.
EN ISO 139, Textiles — Standard atmospheres for conditioning and testing (ISO 139:2005) EN ISO 9073-10, Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state (ISO 9073-10:2003) EN ISO 11737-1:2006, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) EN ISO 13938-1, Textiles — Bursting properties of fabrics — Part 1: Hydraulic method for determination of bursting strength and bursting distension (ISO 13938-1:1999) EN ISO 22610, 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, 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. 3.1 cfu (colony forming unit) unit by which the culturable number of microorganisms is expressed NOTE The culturable number is the number of microorganisms, single cells or aggregates, able to form colonies on a solid nutrient medium. SIST EN 13795:2011
Unit Requirement Standard performance High performance Critical product area Less critical product area Critical product area Less critical product area Resistance to microbial penetration — Dry EN ISO 22612 CFU Not required ≤ 300 a Not required ≤ 300 a Resistance to microbial penetration — Wet EN ISO 22610 IB ≥ 2,8b Not required 6,0 b c Not required Cleanliness — Microbial EN ISO 11737-1 CFU/ 100 cm2 ≤ 300 ≤ 300 ≤ 300 ≤ 300 Cleanliness — Particulate matter EN ISO 9073-10 IPM ≤ 3,5 ≤ 3,5 ≤ 3,5 ≤ 3,5 Linting EN ISO 9073-10 log10 (lint count) ≤ 4,0 ≤ 4,0 ≤ 4,0 ≤ 4,0 Resistance to liquid penetration EN 20811 cm H2O ≥ 30 ≥ 10 ≥ 100 ≥ 10 Bursting strength — Dry EN ISO 13938-1 kPa ≥ 40 ≥ 40 ≥ 40 ≥ 40 Bursting strength — Wet EN ISO 13938-1 kPa ≥ 40 Not required ≥ 40 Not required Tensile strength — Dry EN 29073-3 N ≥ 15 ≥ 15 ≥ 20 ≥ 20 Tensile strength — Wet EN 29073-3 N ≥ 15 Not required ≥ 20 Not required a Test conditions: challenge concentration 108 CFU/g talc. and 30 min vibration time. b The Least Significant Difference (LSD) for IB when estimated using EN ISO 22610, was found to be 0,98 at the 95 % confidence level. This is the minimum difference needed to distinguish between two materials thought to be different. Thus materials varying by up to 0,98 IB are probably not different; materials varying by more than 0,98 IB probably are differen
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