EN 13795-1:2002+A1:2009

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 - Teil 1: Allgemeine Anforderungen für Hersteller, Aufbereiter und ProdukteChamps chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Partie 1: Exigences générales pour les fabricants, les prestataires et les produitsSurgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 13795-1:2002+A1:2009SIST EN 13795-1:2003+A1:2009en,fr,de01-november-2009SIST EN 13795-1:2003+A1:2009SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13795-1:2002+A1
July 2009 ICS 11.140 Supersedes EN 13795-1:2002English Version
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Partie 1: Exigences générales pour les fabricants, les prestataires et les produits
Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 1: Allgemeine Anforderungen für Hersteller, Aufbereiter und Produkte This European Standard was approved by CEN on 2 October 2002 and includes Amendment 1 approved by CEN on 13 June 2009.
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 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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.
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B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13795-1:2002+A1:2009: ESIST EN 13795-1:2003+A1:2009

Comfort . 11Annex B (informative)
Adhesion for fixation and wound isolation . 12Annex C (informative)
Prevention of infection in the operating theatre . 13Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices"""" . 14Bibliography . 15 SIST EN 13795-1:2003+A1:2009

Foreword This document (EN 13795-1:2002+A1:2009) 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 January 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. This document includes Amendment 1, approved by CEN on 2009-06-13. This document supersedes EN 13795-1:2002. The start and finish of text introduced or altered by amendment is indicated in the text by tags !". This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. Annexes A, B and C are informative. This document includes a Bibliography. EN 13795 is expected to consist of the following parts under the general title "Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment": Part 1: General requirements for manufacturers, processors and products Part 2: Test methods Part 3: Performance requirements and performance levels Originally EN 13795 was also to include Part 3: Test method for resistance to dry microbial penetration and Part 4: Test method for resistance to wet microbial penetration. However, it has been decided that these parts will now be developed by the Vienna Agreement/CEN lead route in conjunction with ISO/TC 94/SC 13. As a result, what was to have been EN 13795-3 will be published as EN ISO 22612 Clothing for protection against infectious agents – Test method for resistance to penetration by biologically contaminant dust through protective clothing materials, what was to have been EN 13795-4 will be published as EN ISO 22610 Clothing for protection against infectious agents – Test method for determination of penetration by bacteria through protective clothing materials and what was to have been EN 13795-5 will be published as EN 13795-3. 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, 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. SIST EN 13795-1:2003+A1:2009

Introduction The transmission of infective agents during invasive surgical procedures can occur in several ways (see annex C). !Surgical drapes, including the intended use as a sterile field, gowns and clean air suits 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 C)." 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 blood-borne infective agents carried in blood or body fluids. The EN 13795 series of European Standards, together with EN ISO 22610 and EN ISO 22612, is intended to assist the communication between users, manufacturers and third party verifiers with regard to material or product characteristics. It focuses on relevant Essential Requirements arising from the Medical Device Directive 93/42/EEC. The general requirements and guidance in EN 13795-1 are expected to be of help to manufacturers, test houses and users when designing, processing, assessing and selecting products. It is the intention of EN 13795 to ensure the same level of safety from single-use and reusable surgical clothing and drapes throughout their useful life. 1 Scope This 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 standard gives general guidance 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. It is intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. Surgical masks, surgical gloves, packaging materials, foot and head wear and incision drapes are not covered by EN 13795. Requirements for medical gloves are given in the EN 455 series of European Standards and packaging materials are covered by the EN 868 series. Requirements for surgical masks and head coverings will be specified in future CEN/TC 205 standards. EN 13795 does not cover requirements for flammability of products used in laser surgery. Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards. 2 Terms and definitions For the purposes of this European Standard, the following terms and definitions apply. 2.1 clean air suit suit intended and shown to minimize contamination of the operating wound by the wearer's skin scales carrying infective agents via the operating room air thereby reducing the risk of wound infection NOTE Unlike the suit usually worn in the operation room, the clean air suit is designed to reduce the operating room air contamination by personnel. 2.2 cleanliness freedom from unwanted foreign matter SIST EN 13795-1:2003+A1:2009
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