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 Copyright British Standards Institu
2、tion Reproduced by IHS under license with BSI - Uncontrolled Copy Not for Resale No reproduction or networking permitted without license from IHS - - -BS EN 14126:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 19 January 2004 BSI 22 Oct
3、ober 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 as a member of CEN, is obliged to publish EN 14126 as a British Standard. However, attention is drawn to the fact t
4、hat 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 time of publication ISO 22610 and ISO 22611 have not reached final draft stage and the content may change before the
5、y 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 participation in its preparation was entrusted by Technical Committee PH/3, Protective clothing to Subcommittee PH/3/
6、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-references The British Standards which implement international or European publications referred to in this docume
7、nt 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 British Standards Online. This publication does not purport to include all the necessary provisions of a contract. U
8、sers 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; present to the responsible international/European committee any enquiries on the interpretation, or proposals for chan
9、ge, 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 inside front cover, the EN title page, pages 2 to 23 and a back cover. The BSI copyright notice displayed in this
10、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 A.5.1 Copyright British Standards Institution Reproduced by IHS under license with BSI - Uncontrolled Copy Not for
11、 Resale No reproduction or networking permitted without license from IHS EUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN14126 September2003 ICS13.340.10 Incorporating corrigendum September 2004 Englishversion ProtectiveclothingPerformancerequirementsandtests methodsforprotectiveclothingagainstinfe
12、ctiveagents VtementsdeprotectionExigencesdeperformanceset mthodesdessaipourlesvtementsdeprotectioncontre lesagentsinfectieux SchutzkleidungLeistungsanforderungenund PrfverfahrenfrSchutzkleidunggegenInfektionserreger ThisEuropeanStandardwasapprovedbyCENon1August2003. CENmembersareboundtocomplywiththe
13、CEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexis
14、tsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Fi
15、nland,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandUn ited Kingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2003
16、CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN14126:2003E Copyright British Standards Institution Reproduced by IHS under license with BSI - Uncontrolled Copy Not for Resale No reproduction or networking permitted without license from IHS EN 14126
17、: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 Performance requirements against penetration by infective
18、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 .12 Annex ZA (informative) Clauses of this European
19、Standard addressing essential requirements or other provisions of EU Directives22 Bibliography 23 Copyright British Standards Institution Reproduced by IHS under license with BSI - Uncontrolled Copy Not for Resale No reproduction or networking permitted without license from IHS - - -EN 14126:2003 (E
20、) 3 Foreword This document (EN 14126:2003) has been prepared by Technical Committee CEN/TC 162 “Protective clothing including hand and arm 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 publica
21、tion of an identical text or by endorsement, at the latest by March 2004, and conflicting national standards shall be withdrawn at the latest 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 e
22、ssential requirements of EU Directive(s). For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document. Annex A is normative. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to
23、 implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom. Copyright British Standards Institution Rep
24、roduced by IHS under license with BSI - Uncontrolled Copy Not for Resale No reproduction or networking permitted without license from IHS - - -EN 14126:2003 (E) 4 Introduction Protective clothing against infective agents has two main functions: to prevent infective agents from reaching the (possibly
25、 injured) skin; to prevent 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
26、 contained and the risk 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 biolog
27、ical agents. This happens 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-org
28、anisms are a very heterogeneous 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-orga
29、nisms can be found in 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-org
30、anism. Also it may not 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 thes
31、e risks are present in a given situation. Copyright British Standards Institution Reproduced by IHS under license with BSI - Uncontrolled Copy Not for Resale No reproduction or networking permitted without license from IHS - - -EN 14126:2003 (E) 5 1 Scope This European Standard specifies requirement
32、s 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 during surgical interventions are not covered by the scope of this standard. 2 Normative refer
33、ences 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 are listed hereafter. For dated references, subsequent amendments to or revisions of any of th
34、ese 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). EN 340 1), Protective clothing General requirements. EN 4651) , Protective clothing Protect
35、ion 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 Protection against liquid chemicals Performance requirements for chemical protective clothin
36、g 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 protection to parts of the body. EN 868-1, Packaging materials and systems for medical devic
37、es 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: Performance requirements for ventilated and non-ventilated “gas-tight” (Type 1) and “non-gas-tight”
38、 (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) chemical protective suits for emergency teams (ET). prEN 13034, Protective clothing for use
39、 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 clean air suits, used as medical devices, for patients, clinical stuff and equipment Part 1:
40、 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 clothing providing protection to the full body against solid particulate chemicals (type 5 clot
41、hing) (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, Textiles Standard atmospheres for conditioning and testing (ISO 139:1973). 1) revision curren
42、tly in progress Copyright British Standards Institution Reproduced by IHS under license with BSI - Uncontrolled Copy Not for Resale No reproduction or networking permitted without license from IHS - - -EN 14126:2003 (E) 6 prCEN ISO/TR 11610, Protective clothing Glossary of terms and definitions. (IS
43、O/DTR 11610:2002) ISO/FDIS 16603, Clothing for protection against contact with blood and body 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 wit
44、h blood and body fluids Determination of resistance of protective clothing materials to penetration 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 contamin
45、ated aerosols. ISO/DIS 22612, Clothing for protection against infectious agents Test method for 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
46、/TR 11610:2003 and the following terms and definitions apply. 3.1 infective agents micro-organisms, 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 biologica
47、l agents combined assembly of garments, intended to afford protection to the skin against exposure 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 isolatin
48、g parts of the body from direct contact with an infective agent 3.4 protective suit against infective 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 can be cleaned
