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.
Vêtements de protection - Exigences de performances et méthodes d'essai pour les vêtements de protection contre les agents infectieux
La présente Norme européenne spécifie les exigences et les méthodes d'essai concernant les vêtements de protection réutilisables et à usage limité assurant une protection contre les agents infectieux.
Les vêtements portés par les équipes chirurgicales ou les champs opératoires recouvrant les patients destinés à 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
General Information
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Overview
EN 14126:2003 - "Protective clothing - Performance requirements and test methods for protective clothing against infective agents" (CEN) specifies performance criteria and laboratory test methods for re-usable and limited‑use protective clothing designed to protect wearers and others from infective agents. The standard covers material, seam and whole‑suit requirements, classification levels for liquid, aerosol and particle challenges, marking and manufacturer information. Surgical gowns and patient drapes for cross‑contamination in surgery are excluded.
Key topics and technical requirements
- Scope and application: Applies to protective clothing against biological hazards (infective agents); excludes surgical drapes/gowns used as medical devices.
- Materials and conditioning: Materials intended to be reprocessed must be subjected to the number of cleaning cycles stated by the manufacturer - typically five cycles before testing if care instructions allow. Test specimens are conditioned (20 ±2 °C, 65 ±5 % RH) prior to testing.
- Performance classes:
- Resistance to contaminated liquids under hydrostatic pressure (ISO/FDIS 16603; bacteriophage test ISO/FDIS 16604) - classified by pressure breakthrough levels.
- Resistance to penetration by contaminated liquids due to mechanical contact (normative Annex A - wet bacterial barrier test).
- Resistance to contaminated liquid aerosols (ISO/DIS 22611) - classified by penetration ratio (log).
- Resistance to contaminated solid particles/dust (ISO/DIS 22612) - classified by logarithmic colony forming units (log cfu).
- Seams and joins: Seams, joins and assemblages must meet strength and barrier requirements per prEN 14325.
- Whole suit requirements: Comply with EN 340 general PPE requirements and the appropriate chemical-protective clothing standard (e.g., EN 943-1/2 for gas-tight suits, EN 466/465/ prEN ISO 13982-1 / prEN 13034 for other types). Suits are classified with a “-B” suffix (e.g., type 3‑B).
- Marking & information: Clothing must be marked with the standard number, type designation, and the biological hazard pictogram. Manufacturer information must include tested biological performance levels and use/maintenance guidance.
Practical applications and users
- Who uses EN 14126:
- PPE manufacturers validating protective clothing performance against biological hazards.
- Independent testing laboratories performing barrier and penetration tests.
- Occupational health & safety professionals specifying PPE for high‑risk environments.
- Industrial and public sectors: microbiology/biotech labs, waste and sewage treatment, animal handling with zoonotic risk, emergency response and hazardous‑materials teams, and hospital/clinical settings (non‑surgical uses).
- Benefits: Provides objective test methods and classification to select appropriate protective suits for specific biological exposure risks (liquid, aerosol, dust), supports regulatory compliance and informed procurement.
Related standards
- EN 340 (general PPE requirements)
- EN 943-1 / EN 943-2 (gas‑tight chemical suits)
- prEN 14325 (chemical protective clothing test methods)
- ISO/FDIS 16603, ISO/FDIS 16604 (synthetic blood and bacteriophage penetration tests)
- ISO/DIS 22611, ISO/DIS 22612 (aerosol and dust penetration tests)
- prEN ISO 13982-1, prEN 13034 (type 5/6 protective clothing)
Keywords: EN 14126:2003, protective clothing, infective agents, biological hazard, test methods, performance requirements, protective suits, hydrostatic pressure, bacteriophage test, aerosol penetration.
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
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
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
2)European Directive 90/679/EEC on the protection of workers from the risk related to exposure to biological agents atwork.
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.
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.
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Frequently Asked Questions
EN 14126:2003 is a standard published by the European Committee for Standardization (CEN). Its full title is "Protective clothing - Performance requirements and tests methods for protective clothing against infective agents". This standard covers: 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.
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.
EN 14126:2003 is classified under the following ICS (International Classification for Standards) categories: 13.340.10 - Protective clothing. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 14126:2003 has the following relationships with other standards: It is inter standard links to EN 14126:2003/AC:2004, prEN ISO 22615. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 14126:2003 is associated with the following European legislation: EU Directives/Regulations: 2016/425, 89/686/EEC, 93/68/EEC, 93/95/EEC, 96/58/EC; Standardization Mandates: M/BC/CEN/88/10. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN 14126:2003 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
SIST EN 14126:2003は、感染性エージェントに対する保護服の性能要件と試験方法を定めた標準であり、リユース可能および限定使用の保護服に対して必要な要件を明確にしています。この標準は、医療現場における感染症のリスクを低減するために重要であり、特に感染性物質からの防護を強化することに寄与しています。 この標準の強みは、詳細な試験方法と明確な性能要件を提供している点にあります。具体的には、保護服がどのような条件下で感染性エージェントからどれだけの保護を提供するかを評価するための基準を設けているため、製造者や使用者が安心して製品を使用できる根拠を与えます。 さらに、SIST EN 14126:2003の適用範囲は、感染性エージェントからの防護が必要なさまざまな状況において非常に関連性があります。特に、手術チームが使用する保護服や、患者の交差汚染を防ぐために使用されるドレープには適用されないものの、他の多くの場面での使用が想定され、幅広い医療現場での安全性向上に寄与します。 このように、SIST EN 14126:2003は医療業界にとって不可欠な標準であり、感染拡大を防ぐための強固な基盤を提供しています。
SIST EN 14126:2003 표준은 감염성 물질로부터 보호하기 위한 보호 의류의 성능 요구사항 및 시험 방법을 규정하고 있습니다. 이 표준은 재사용 가능한 보호 의류와 제한적으로 사용할 수 있는 보호 의류에 대해 적용됩니다. 감염성 물질로 인해 야기될 수 있는 위험으로부터 사용자와 환자를 보호하는 것이 이 표준의 핵심 목적입니다. 이 표준의 강점 중 하나는 다양한 테스트 방법을 통해 의류의 성능을 객관적으로 평가할 수 있도록 명확한 기준을 제공한다는 점입니다. 이는 의료 환경에서의 안전성을 크게 향상시키는 데 기여합니다. 또한, 다양한 감염성 물질에 대한 보호 성능을 검증할 수 있도록 설계되어 있어, 실제 사용하는 환경에서의 신뢰성을 높이는 데 중요한 역할을 합니다. SIST EN 14126:2003 표준은 의료 및 산업 분야에서 감염성 물질에 대한 노출을 최소화하고, 의료 종사자와 환자 모두의 안전을 보장하는 데 필수적입니다. 특히, 수술 팀이 착용하는 의류나 환자 위에 덮는 드레이프와 같은 특정 용도에 대한 규정이 제외되어 있어, 보다 전문화된 보호 의류의 기준을 제시합니다. 이와 같은 표준은 감염성 질환의 예방과 관리 방안으로서, 병원 및 의료 기관에서 효과적인 감염 통제를 위한 기초 자료로 활용될 수 있어 현대 의료 시스템의 질을 높이는 데 매우 중요한 요소로 작용합니다.
The EN 14126:2003 standard, titled "Protective clothing - Performance requirements and test methods for protective clothing against infective agents," serves a crucial role in safeguarding health professionals and patients from biologically hazardous contaminants. Its scope focuses on establishing comprehensive requirements and testing methodologies for both reusable and limited-use protective clothing designed to offer protection against infective agents. One of the primary strengths of this standard is its rigorous approach to performance requirements. It ensures that the protective clothing meets specific criteria that align with the challenges posed by infective agents. The emphasis on detailed test methods adds a level of credibility, ensuring that manufacturers can validate the efficacy of their products. This standard sets a baseline for quality, ultimately enhancing patient safety and supporting healthcare environments in effectively managing infection control. Moreover, the relevance of EN 14126:2003 is underscored by its applicability across various settings where protective clothing is essential. Although it explicitly excludes clothing used by surgical teams or drapes placed on patients, the standard fills a critical gap for other healthcare personnel and industries at risk of exposure to infective agents. Its specificity to protective clothing promotes a clear understanding among manufacturers and end-users regarding compliance and safety. By offering a consistent framework for the evaluation of protective clothing, the EN 14126:2003 standard not only contributes to improved protection against infective agents but also serves as a benchmark for industry practices, thereby reinforcing the overall standards of safety in healthcare environments.
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