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1、BRITISH STANDARD BS EN 13795-1:2002 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 The European Standard EN 13795-1:2002 has the status of a British Standard ICS 1
2、1.140 ? BS EN 13795-1:2002 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 29 November 2002 BSI 29 November 2002 ISBN 0 580 40866 3
3、National foreword This British Standard is the official English language version of EN 13795-1:2002. The UK participation in its preparation was entrusted by Technical Committee CH/205, Non-active medical devices, to Subcommittee CH/205/1, Medical textiles, which has the responsibility to: A list of
4、 organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standard
5、s Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard do
6、es not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European deve
7、lopments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 15 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication
8、 Amd. No. DateComments EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13795-1 November 2002 ICS 11.140 English 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 an
9、d products Champs chirurgicaux, casaques et tenues de bloc, utiliss en tant que dispositifs mdicaux, pour les patients, le personnel et les quipements - Partie 1: Exigences gnrales pour les fabricants, les prestataires et les produits Operationsabdecktcher, -mntel und Rein-Luft-Kleidung zur Verwendu
10、ng als Medizinprodukte fr Patienten, Klinikpersonal und Gerte - Teil 1: Allgemeine Anforderungen fr Hersteller, Aufbereiter und Produkte This European Standard was approved by CEN on 2 October 2002. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditi
11、ons 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 Management Centre or to any CEN member. This European Standard exists in three offi
12、cial 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 Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Be
13、lgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management
14、Centre: rue de Stassart, 36 B-1050 Brussels 2002 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13795-1:2002 E EN 13795-1:2002 (E) 2 Contents page Foreword3 Introduction.4 1Scope 4 2Terms and definitions4 3Information to be supplie
15、d by the manufacturer or processor.7 4Manufacturing and processing requirements.9 5Testing requirements 10 Annex A (informative) Comfort 11 Annex B (informative) Adhesion for fixation and wound isolation12 Annex C (informative) Prevention of infection in the operating theatre13 Annex ZA (informative
16、) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives14 Bibliography15 EN 13795-1:2002 (E) 3 Foreword This document EN 13795-1:2002 has been prepared by Technical Committee CEN /TC 205 “Non-active medical devices“, the secretariat of which is held
17、 by BSI. 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 May 2003, and conflicting national standards shall be withdrawn at the latest by May 2003. This document has been prepared under a mandate
18、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 incl
19、udes 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 me
20、thods 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 develope
21、d 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 protectiv
22、e 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
23、-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, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands,
24、 Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. EN 13795-1:2002 (E) 4 Introduction The transmission of infective agents during invasive surgical procedures can occur in several ways (see annex C). Surgical drapes, gowns and clean air suits are used to minimize the spread of inf
25、ective 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 t
26、he 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 bod
27、y 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 f
28、rom 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 sin
29、gle-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 requi
30、rements. 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
31、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 cov
32、ered 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 radia
33、tion, 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 defin
34、itions apply. 2.1 clean air suit suit intended and shown to minimize contamination of the operating wound by the wearers skin scales carrying infective agents via the operating room air thereby reducing the risk of wound infection NOTEUnlike the suit usually worn in the operation room, the clean air
35、 suit is designed to reduce the operating room air contamination by personnel. 2.2 cleanliness freedom from unwanted foreign matter EN 13795-1:2002 (E) 5 NOTESuch matter can be micro-organisms, organic residues or particulate matter. 2.2.1 cleanliness microbial freedom from population of viable micr
36、o-organisms on a product and/or a package NOTEIn practical use microbial cleanliness is often referred to as “bioburden“. 2.2.2 cleanliness particulate matter freedom from particles that are contaminating a material and can be released but are not generated by mechanical impact 2.3 critical product
37、area product area with a greater probability to be involved in the transfer of infective agents to or from the wound, e.g. front and sleeves of surgical gowns 2.4 drapeability ability of a material to conform to a given shape or object 2.5 fabric cloth made from yarn or fibres by weaving, knitting a
38、nd/or other types of binding or manufacture 2.6 fixation adhesion of a surgical drape to the patient for the purpose of wound isolation NOTESee annex B. 2.7 infective agent micro-organism that has been shown to cause a wound infection or that might cause infection in a member of the surgical team or
39、 the patient 2.8 linting release of fibre fragments and other particles during handling and use NOTEThese fragments and particles are originally from the fabric itself. 2.9 manufacturer natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device befor
40、e it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party NOTEFrom the Medical Device Directive 93/42/EEC. 2.10 processor natural or legal person who processes reusable product items so that their
41、performance complies with the requirements of this standard NOTEA processor who places a product on the market is a manufacturer in the sense of this standard. 2.11 resistance to liquid penetration ability of material to resist the penetration of liquid(s) from one side of the material through to th
42、e other EN 13795-1:2002 (E) 6 2.12 resistance to microbial penetration ability of material(s) to withstand penetration of micro-organisms from one side through to the other 2.12.1 dry penetration effect of a combination of air movement and mechanical action by vibration on microbial penetration in d
43、ry condition 2.12.2 wet penetration effect of combination of wetness, pressure and rubbing on microbial penetration 2.13 reusable product product intended by the manufacturer to be reprocessed and reused 2.14 single-use product product intended by the manufacturer to be used for only one surgical pr
44、ocedure before disposal 2.15 surgical drape drape covering the patient or equipment to prevent transfer of infective agents 2.16 surgical gown gown worn by a member of a surgical team to prevent transfer of infective agents 2.17 surgical procedure surgical intervention penetrating skin or mucosa, pe
45、rformed by a surgical team 2.17.1 clean operation operation performed on uninfected, non-traumatised tissue and in which respiratory, alimentary or genito-urinary tracts are not entered 2.17.2 infection-prone operation operation where the nature of the operation or the condition of the patient is su
46、ch that infection can occur with minimal contamination 2.17.3 invasive surgical procedure procedure that reaches the inside of the body through the body surface 2.18 water-vapour resistance water-vapour pressure difference between the two faces of a material divided by the resultant evaporative heat
47、 flux per unit area in the direction of the gradient. The evaporative heat flux can consist of both diffusive and convective components EN 13795-1:2002 (E) 7 3 Information to be supplied by the manufacturer or processor 3.1 The following information shall be supplied: a) if the device is intended by
48、 the manufacturer to be reused, information on the appropriate processes to allow reuse, including cleaning, disinfection, packing and, if appropriate, the methods of sterilization of the device to be resterilized, the number of reuses and any restriction to the reuse; b) if the device is supplied w
49、ith the intention that it be sterilized before use, instructions for sterilization methods; c) if the manufacturer differentiates between critical and less critical areas of the product, the identification of these areas. 3.2 The following information shall be supplied on request: a) the identity or information on the test methods used; b) the results of testing for the characteristics given in Tables 1, 2 and 3; c) if the manufacturer differentiates between critical and less