EN 14126-2003 en Protective clothing - Performance requirements and tests methods for protective clothing against infective agents (Incorporating corrigendum September 2004)《防护服 防传.pdf

1、BRITISH STANDARD BS EN 14126:2003 Incorporating Corrigendum No. 1 Protective clothing Performance requirements and tests methods for protective clothing against infective agents The European Standard EN 14126:2003 has the status of a British Standard ICS 13.340.10 BS EN 14126:2003 This British Stand

2、ard was published under the authority of the Standards Policy and Strategy Committee on 19 January 2004 BSI 22 October 2004 ISBN 0 580 43288 2 National foreword This British Standard is the official English language version of EN 14126:2003, including Corrigendum September 2004. The United Kingdom a

3、s a member of CEN, is obliged to publish EN 14126 as a British Standard. However, attention is drawn to the fact that during the development of this European Standard, the United Kingdom consistently voted against its approval as a European Standard. The reason for this disapproval is that at the ti

4、me of publication ISO 22610 and ISO 22611 have not reached final draft stage and the content may change before they do reach that stage. The UK cannot therefore guarantee that the final versions of these ISOs will convey the information originally intended by the authors of this standard. The UK par

5、ticipation in its preparation was entrusted by Technical Committee PH/3, Protective clothing to Subcommittee PH/3/3, Clothing for protection against chemicals which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-

6、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 Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of Br

7、itish 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 does not of itself confer immunity from legal obligations. aid enquirers to understand the text; pres

8、ent 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 developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an

9、inside front cover, the EN title page, pages 2 to 23 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments 15402 Corrigendum No. 1 22 October 2004 Change to Clause 2 and subclause

10、A.5.1EUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN14126 September2003 ICS13.340.10 Incorporating corrigendum September 2004 Englishversion ProtectiveclothingPerformancerequirementsandtests methodsforprotectiveclothingagainstinfectiveagents VtementsdeprotectionExigencesdeperformanceset mthodesdes

11、saipourlesvtementsdeprotectioncontre lesagentsinfectieux SchutzkleidungLeistungsanforderungenund PrfverfahrenfrSchutzkleidunggegenInfektionserreger ThisEuropeanStandardwasapprovedbyCENon1August2003. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingth

12、isEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherl

13、anguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembour

14、g,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandUn ited Kingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2003CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwidef

15、orCENnationalMembers. Ref.No.EN14126:2003EEN 14126:2003 (E) 2 Contents page Foreword3 1 Scope5 2 Normative references5 3 Terms and definitions .6 4 Requirements.6 4.1 Materials requirements.6 4.1.1 General6 4.1.2 Mechanical and flammability requirements 7 4.1.3 Chemical requirements.7 4.1.4 Performa

16、nce requirements against penetration by infective agents.7 4.2 Performance requirements for seams, joins and assemblages .8 4.3 Whole suit requirements.9 5 Marking.10 6 Information supplied by the manufacturer .11 Annex A (normative) Test method for resistance to wet bacterial barrier penetration .1

17、2 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives22 Bibliography 23 EN 14126:2003 (E) 3 Foreword This document (EN 14126:2003) has been prepared by Technical Committee CEN/TC 162 “Protective clothing including hand and a

18、rm protection and life jackets”, 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 March 2004, and conflicting national standards shall be withdrawn at the l

19、atest by March 2004. 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

20、this document. Annex A is normative. 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, Hungary, Iceland, Irelan

21、d, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom. EN 14126:2003 (E) 4 Introduction Protective clothing against infective agents has two main functions: to prevent infective agents from reaching the (possibly injured) skin; to pre

22、vent the spreading of infective agents to other people and other situations, e.g. eating or drinking, when the person has taken his protective clothing off. In many work situations, e.g. microbiological laboratories, biotechnological production, etc. the infective agents can be contained and the ris

23、k of exposure is limited to the occurrence of an accident. In these situations the agents, to which the worker can be exposed, are usually well known. In other types of work, the organisms can not be contained, exposing the worker continuously to the risk of infection by biological agents. This happ

24、ens e.g. in sewage work, waste treatment, caring for animals infected with zoonotic agents, emergency clean-up, treatment of hospital risk waste etc. In these situations, the agents the workers are exposed to, may not be known, although possible risks can be assessed. Micro-organisms are a very hete

25、rogeneous group of organisms as to their size, shape, living conditions, infective dose, survival abilities and many other parameters. Their size alone can vary from 30 nm (poliovirus) to 5 m to 10 m (bacteria) and even larger (most fungi). A hazard classification of micro-organisms can be found in

26、European Directive 2000/54/EEC (on the protection of workers from the risk related to exposure to biological agents at work). Due to the heterogeneity of micro-organisms, it is not possible to define performance criteria on the basis of risk groups, nor on the type of micro-organism. Also it may not

27、 be possible to define exactly the organisms the worker is exposed to. Hence the test methods specified in this standard focus on the medium containing the micro-organism, such as a liquid, an aerosol or a solid dust particle. A risk analysis should determine which ones of these risks are present in

28、 a given situation. EN 14126:2003 (E) 5 1 Scope This European Standard specifies requirements and test methods for re-usable and limited use protective clothing providing protection against infective agents. Clothing worn by surgical teams or drapes laid on patients to prevent cross-contamination du

29、ring surgical interventions are not covered by the scope of this standard. 2 Normative references This European standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text, and the publications ar

30、e listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments).

31、 EN 340 1), Protective clothing General requirements. EN 4651) , Protective clothing Protection against liquid chemicals Performance requirements for chemical protective clothing with spray-tight connections between different parts of the clothing (Type 4 Equipment). EN 466 1) , Protective clothing

32、Protection against liquid chemicals Performance requirements for chemical protective clothing with liquid-tight connections between different parts of the clothing (Type 3 Equipment). EN 467 1) , Protective clothing Protection against liquid chemicals Performance requirements for garments providing

33、protection to parts of the body. EN 868-1, Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods. EN 943-1, Protective clothing against liquid and gaseous chemicals, including liquid aerosols and solid particles Part 1: Perform

34、ance requirements for ventilated and non-ventilated “gas-tight” (Type 1) and “non-gas-tight” (Type 2) chemical protective suits. EN 943-2, Protective clothing against liquid and gaseous chemicals, including liquid aerosols and solid particles Part 2: Performance requirements for “gas-tight” (Type 1)

35、 chemical protective suits for emergency teams (ET). prEN 13034, Protective clothing for use against liquid chemicals Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (type 6 equipment). EN 13795-1, Surgical drapes, gowns and

36、clean air suits, used as medical devices, for patients, clinical stuff and equipment Part 1: General requirements for manufacturers, processors and products. prEN ISO 13982-1, Protective clothing for use against solid particulate chemicals Part 1: Performance requirements for chemical protective clo

37、thing providing protection to the full body against solid particulate chemicals (type 5 clothing) (ISO/DIS 13982-1:2000). PrEN 14325, Protective clothing against chemicals Test methods and performance classification of chemical protective clothing materials, seams, joins and assemblages. EN 20139, T

38、extiles Standard atmospheres for conditioning and testing (ISO 139:1973). 1) revision currently in progress EN 14126:2003 (E) 6 prCEN ISO/TR 11610, Protective clothing Glossary of terms and definitions. (ISO/DTR 11610:2002) ISO/FDIS 16603, Clothing for protection against contact with blood and body

39、fluids Determination of the resistance of protective clothing materials to penetration by blood and body fluids Test method using synthetic blood. ISO/FDIS 16604, Clothing for protection against contact with blood and body fluids Determination of resistance of protective clothing materials to penetr

40、ation by blood-borne pathogens Test method using Phi- X-174 Bacteriophage. ISO/DIS 22611, Clothing for protection against infectious agents Test method for resistance to penetration by biologically contaminated aerosols. ISO/DIS 22612, Clothing for protection against infectious agents Test method fo

41、r resistance to penetration by biologically contaminant dust through protective clothing materials. 3 Terms and definitions For the purposes of this European Standard, the terms and definitions of prCEN ISO/TR 11610:2003 and the following terms and definitions apply. 3.1 infective agents micro-organ

42、isms, including those which have been genetically modified, cell cultures and human endoparasites, which may be able to provoke any infection, allergy or toxicity 2)3.2 protective clothing against biological agents combined assembly of garments, intended to afford protection to the skin against expo

43、sure to or contact with infective agents 3.3 protective clothing material against infective agents any material or combination of materials used in an item of protective clothing for the purpose of isolating parts of the body from direct contact with an infective agent 3.4 protective suit against in

44、fective agents suit protecting against infective agents which can be hazardous to the health. A suit may have various types of additional protection such as a hood or helmet, boots and gloves 4 Requirements 4.1 Materials requirements 4.1.1 General If the care instructions indicate that the clothing

45、can be cleaned and reprocessed at least five times, protective clothing materials shall be submitted to five cleaning and reprocessing cycles according to the manufacturers care instructions before testing. 2)European Directive 90/679/EEC on the protection of workers from the risk related to exposur

46、e to biological agents at work.EN 14126:2003 (E) 7 If the care instructions specify a lower number of cleaning/reprocessing cycles, then materials shall be submitted to the number of cleaning/reprocessing cycles indicated. Unless otherwise stated in the relevant test procedure, the specimens shall b

47、e conditioned for at least 24 h in an atmosphere of (20 2) C and (65 5) % relative humidity before testing. Tests shall be carried out in the same atmosphere or within 5 min of removing the sample from the conditioning atmosphere. 4.1.2 Mechanical and flammability requirements The materials shall be

48、 tested and classified in accordance with the test methods and performance classification system specified in the relevant clauses of prEN 14325. 4.1.3 Chemical requirements If protection against chemicals is claimed, the materials shall be tested and classified in accordance with the test methods and performance classification system specified in the relevant clauses of prEN 14325. 4.1.4 Performance requirements against penetration by infective agents 4.1.4.1 Resistance to penetration by contaminated li