SIST EN 14126:2003
(Main)Protective clothing - Performance requirements and tests methods for protective clothing against infective agents
Protective clothing - Performance requirements and tests methods for protective clothing against infective agents
This 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 during surgical interventions, are not covered by the scope of this standard.
Schutzkleidung - Leistungsanforderungen und Prüfverfahren für Schutzkleidung gegen Infektionserreger
Diese Europäische Norm legt Anforderungen und Prüfverfahren für wiederverwendbare und im Gebrauch begrenzte Schutzkleidung gegen Infektionserreger fest.
Von chirurgischen Arbeitsgruppen getragene Kleidung oder Abdecktücher für die Patienten zur Verhinderung einer Kreuzkontamination während chirurgischer Eingriffe fallen nicht in den Anwendungsbereich dieser Norm.
Vetements de protection - Exigences de performances et méthodes d'essai pour les vetements de protection contre les agents infectieux
La présente Norme européenne spécifie les exigences et les méthodes d'essai concernant les vetements de protection réutilisables et a usage limité assurant une protection contre les agents infectieux.
Les vetements portés par les équipes chirurgicales ou les champs opératoires recouvrant les patients destinés a prévenir toute contamination croisée lors d'interventions chirurgicales ne sont pas traités dans le domaine d'application de la présente norme.
Varovalna obleka – Zahteve za izdelavo in preskusne metode za varovalno obleko proti povzročiteljem infekcije
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Protective clothing - Performance requirements and tests methods for protective clothing against infective agentsVetements de protection - Exigences de performances et méthodes d'essai pour les vetements de protection contre les agents infectieuxSchutzkleidung - Leistungsanforderungen und Prüfverfahren für Schutzkleidung gegen Infektionserreger13.340.10Varovalna oblekaProtective clothingICS:SIST EN 14126:2003enTa slovenski standard je istoveten z:EN 14126:200301-december-2003SIST EN 14126:2003SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14126September 2003ICS 13.340.10English versionProtective clothing - Performance requirements and testsmethods for protective clothing against infective agentsVêtements de protection - Exigences de performances etméthodes d'essai pour les vêtements de protection contreles agents infectieuxSchutzkleidung - Leistungsanforderungen undPrüfverfahren für Schutzkleidung gegen InfektionserregerThis European Standard was approved by CEN on 1 August 2003.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and UnitedKingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2003 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14126:2003 E
EN 14126:2003 (E)2ContentspageForeword.31Scope.52Normative references.53Terms and definitions.64Requirements.64.1Materials requirements.64.1.1General.64.1.2Mechanical and flammability requirements.74.1.3Chemical requirements.74.1.4Performance requirements against penetration by infective agents.74.2Performance requirements for seams, joins and assemblages.84.3Whole suit requirements.95Marking.106Information supplied by the manufacturer.11Annex A (normative)
Test method for resistance to wet bacterial barrier penetration.12Annex ZA
(informative) Clauses of this European Standard addressing essential requirements orother provisions of EU Directives.22Bibliography.23
EN 14126:2003 (E)3ForewordThis document (EN 14126:2003) has been prepared by Technical Committee CEN/TC 162 “Protectiveclothing 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 publication of an identicaltext or by endorsement, at the latest by March 2004, and conflicting national standards shall be withdrawn atthe latest by March 2004.This document has been prepared under a mandate given to CEN by the European Commission and theEuropean 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.Annex A is normative.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to 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.
EN 14126:2003 (E)4IntroductionProtective clothing against infective agents has two main functions: to prevent infective agents from reaching the (possibly 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 infectiveagents can be contained and the risk of exposure is limited to the occurrence of an accident. In thesesituations the agents, to which the worker can be exposed, are usually well known. In other types of work, theorganisms can not be contained, exposing the worker continuously to the risk of infection by biological 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 areexposed to, may not be known, although possible risks can be assessed.Micro-organisms 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 µm to 10 µm (bacteria) and even larger (most fungi). A hazard classification of micro-organisms can befound in European Directive 2000/54/EEC (on the protection of workers from the risk related to exposure tobiological agents at work).Due to the heterogeneity of micro-organisms, it is not possible to define performance criteria on the basis ofrisk groups, nor on the type of micro-organism. Also it may not be possible to define exactly the organisms theworker is exposed to. Hence the test methods specified in this standard focus on the medium containing themicro-organism, such as a liquid, an aerosol or a solid dust particle. A risk analysis should determine whichones of these risks are present in a given situation.
EN 14126:2003 (E)51 ScopeThis European Standard specifies requirements and test methods for re-usable and limited use protectiveclothing providing protection against infective agents.Clothing worn by surgical teams or drapes laid on patients to prevent cross-contamination during surgicalinterventions are not covered by the scope of this standard.2 Normative referencesThis 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 listedhereafter. For dated references, subsequent amendments to or revisions of any of these publications apply tothis European standard only when incorporated in it by amendment or revision. For undated references thelatest edition of the publication referred to applies (including amendments).EN 340 1) , Protective clothing — General requirements.EN 465 1), Protective clothing — Protection against liquid chemicals – Performance requirements for chemicalprotective 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 chemicalprotective 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 garmentsproviding protection to parts of the body.EN 868-1, Packaging materials and systems for medical devices which are
to be sterilized - Part 1: Generalrequirements and test methods.EN 943-1, Protective clothing against liquid and gaseous chemicals, including liquid aerosols and solidparticles — Part 1: Performance 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 solidparticles — Part 2: Performance requirements for “gas-tight” (Type 1) chemical protective suits for emergencyteams (ET).prEN 13034, Protective clothing for use against liquid chemicals — Performance requirements for chemicalprotective 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 stuffand equipment - Part 1:
General requirements for manufacturers, processors and
products.prEN ISO 13982-1, Protective clothing for use against solid particulate chemicals — Part 1: Performancerequirements for chemical protective clothing providing protection to the full body against solid particulatechemicals (type 5 clothing) (ISO/DIS 13982-1:2000).prEN 14325, Protective clothing against chemicals — Test methods and performance classification ofchemical protective clothing materials, seams, joins and assemblages.ISO 139, Textiles; Standard atmospheres for conditioning and testing.
1)revision currently in progress
EN 14126:2003 (E)6prCEN 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 fluids — Determination of theresistance of protective clothing materials to penetration by blood and body fluids — Test method usingsynthetic blood.ISO/FDIS 16604, Clothing for protection against contact with blood and body fluids — Determination ofresistance 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 penetrationby biologically contaminated aerosols.ISO/DIS 22612, Clothing for protection against infectious agents — Test method for resistance to penetrationby biologically contaminant dust through protective clothing materials.3 Terms and definitionsFor the purposes of this European Standard, the terms and definitions of prCEN ISO/TR 11610:2003 and thefollowing terms and definitions apply.3.1infective agentsmicro-organisms, including those which have been genetically modified, cell cultures and humanendoparasites, which may be able to provoke any infection, allergy or toxicity 2)3.2protective clothing against biological agentscombined assembly of garments, intended to afford protection to the skin against exposure to or contact withinfective agents3.3protective clothing material against infective agentsany material or combination of materials used in an item of protective clothing for the purpose of isolatingparts of the body from direct contact with an infective agent3.4protective suit against infective agentssuit protecting against infective agents which can be hazardous to the health. A suit may have various types ofadditional protection such as a hood or helmet, boots and gloves4 Requirements4.1 Materials requirements4.1.1 GeneralIf the care instructions indicate that the clothing can be cleaned and reprocessed at least five times, protectiveclothing materials shall be submitted to five cleaning and reprocessing cycles according to the manufacturer’scare instructions before testing.
2)European Directive 90/679/EEC on the protection of workers from the risk related to exposure to biological agents atwork.
EN 14126:2003 (E)7If the care instructions specify a lower number of cleaning/reprocessing cycles, then materials shall besubmitted to the number of cleaning/reprocessing cycles indicated.Unless otherwise stated in the relevant test procedure, the specimens shall be conditioned for at least 24 h inan atmosphere of (20
2) °C and (65
5) % relative humidity before testing. Tests shall be carried out in thesame atmosphere or within 5 min of removing the sample from the conditioning atmosphere.4.1.2 Mechanical and flammability requirementsThe materials shall be tested and classified in accordance with the test methods and performanceclassification system specified in the relevant clauses of prEN 14325.4.1.3 Chemical requirementsIf protection against chemicals is claimed, the materials shall be tested and classified in accordance with thetest methods and performance classification system specified in the relevant clauses of prEN 14325.4.1.4 Performance requirements against penetration by infective agents4.1.4.1 Resistance to penetration by contaminated liquids under hydrostatic pressureWhen tested in accordance with ISO/FDIS 16603 and ISO/FDIS 16604 the material shall be classifiedaccording to the levels of performance given in Table 1, as obtained in the bacteriophage test(ISO/FDIS 16604).NOTEThe synthetic blood test (ISO/FDIS 16603) is used for screening purposes, i.e. to predict the level where astrikethrough can be expected when performing the bacteriophage test (ISO/FDIS 16604)Table 1 — Classification of resistance to penetration by contaminated liquids under hydrostaticpressure (ISO/FDIS 16604)ClassHydrostatic pressure at whichthe material passes the test620 kPa514 kPa47 kPa33,5 kPa21,75 kPa10 kPa aathis means that the material is only exposed tothe hydrostatic pressure of the liquid in the test cell4.1.4.2 Resistance to penetration by infective agents due to mechanical contact with substancescontaining contaminated liquids.When tested in accordance with Annex A the material shall be classified according to the levels ofperformance given in Table 2.
EN 14126:2003 (E)8Table 2 — Classification of resistance to penetration by infective agents due to mechanical contactwith substances containing contaminated liquidsClassBreakthrough time, tmin6t > 75560 < t 445 < t
330 < t
215 < t
14.1.4.3 Resistance to penetration by contaminated liquid aerosolsWhen tested in accordance with ISO/DIS 22611 the material shall be classified according to the levels ofperformance given in Table 3.Table 3 — Classification of resistance to penetration by contaminated liquid aerosolsClassPenetration ratio (log)3 log > 523 < log 11 < log 4.1.4.4 Resistance to penetration by contaminated solid particles.When tested in accordance with ISO/DIS 22612 the material shall be classified according to the levels ofperformance given in Table 4.Table 4 — Classification of resistance to penetration by contaminated solid particlesClassPenetration (log cfu)3 121 < log cfu
212 < log cfu
34.2 Performance requirements for seams, joins and assemblagesSeams, joins and assemblages of protective clothing against infective agents shall fulfil the requirementsspecified in the relevant clauses of prEN 14325 Seam strength shall be classified according to 5.5 of prEN14325:2001.
EN 14126:2003 (E)94.3 Whole suit requirementsProtective clothing against infective agents shall fulfil the relevant requirements of EN 340 and the whole suitrequirements specified in the relevant standard for chemical protective clothing (see Table 5).The materials and design used shall not cause skin irritation nor have any adverse effect to health.NOTEThe suit should be as light and as flexible as possible in order to ensure the comfort of the wearer, not tohinder movements and still provide at the same time effective protection.
EN 14126:2003 (E)10Table 5 — Types of protective clothing against infective agentsType of clothingRelevant standardtype 1a, 1b, 1c, 2EN 943-1 (EN 943-2 for ET suits)type 3EN 466type 4EN 465type 5prEN ISO 13982-1type 6prEN 13034partial body protectionEN 4675 MarkingThe clothing shall be marked in accordance with the applicable requirements of the relevant standard forchemical protective clothing.The marking of protective clothing against infective agents shall contain the following additional information:a) the number of this European Standard;b) the type of protective clothing, as specified in Table 5, with the suffix “-B”, e.g. type 3-B;c) the pictogram “protection against biological hazard”
EN 14126:2003 (E)116 Information supplied by the manufacturerThe information for the user shall be worded clearly and unambiguously and be understandable by a trainedperson.The information for the user of protective clothing against infective agents shall contain all the informationrequired by EN 340 and by the relevant standard for that specific type of chemical protective clothing. Inaddition it shall contain the following information:a) the n
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