EN ISO 22612:2005
(Main)Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)
Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)
ISO 22612:2005 specifies a test method for assessing the resistance to penetration through barrier materials of bacteria-carrying particles.
Due to its complexity, this ISO 22612:2005 cannot be considered as a useful method for routine quality control but may suit the needs when a material is assessed for compliance with the requirements of current regulations such as EU Directive 93/42/EEC.
Schutzkleidung gegen infektiöse Agenzien - Prüfverfahren zur Beständigkeit gegen mikrobielle Penetration im trockenen Zustand (ISO 22612:2005)
Dieses Prüfverfahren liefert ein Mittel zur Beurteilung der Widerstandsfähigkeit von Materialien mit Barrierewirkung gegen die Penetration durch Bakterien tragende Partikel.
ANMERKUNG Aufgrund ihres komplexen Charakters ist die EN ISO 22612 nicht für die Routine-Qualitätskontrolle geeignet. Sie kann aber eingesetzt werden, wenn ein Material auf Konformität mit aktuellen Bestimmungen, wie der EU Richtlinie 93/42/EWG, überprüft werden soll.
Vêtements de protection contre les agents infectieux - Méthode d'essai pour la résistance à la pénétration microbienne sèche (ISO 22612:2005)
L'ISO 22612:2005 spécifie une méthode d'essai pour évaluer la résistance de matériaux de protection à la pénétration de particules porteuses de bactéries.
En raison de sa complexité, l'ISO 22612:2005 ne peut pas être considérée comme une méthode adaptée au contrôle classique de la qualité mais elle répond bien aux besoins pour évaluer la conformité d'un matériau aux exigences des réglementations en vigueur telles que la Directive UE 93/42/CEE.
Obleka za varovanje pred povzročitelji infekcij - Preskusna metoda za odpornost proti prodiranju suhih mikrobov (ISO 22612:2005)
General Information
Overview - EN ISO 22612:2005 (Clothing for protection against infectious agents)
EN ISO 22612:2005 specifies a laboratory test method for resistance to dry microbial penetration of barrier materials used in protective clothing (e.g., surgical gowns, clean air suits). The standard evaluates the ability of bacteria‑carrying particles (the size range typical of human skin scales) to penetrate fabrics in the dry state. Because of its procedural complexity, EN ISO 22612:2005 is intended for conformity assessment and regulatory evaluation (for example in support of EU Directive 93/42/EEC) rather than routine quality control.
Key topics and technical requirements
- Test principle: Contaminated talc (carrying spores of Bacillus subtilis) is placed on the outside of a test specimen fixed over a stainless steel container; a sedimentation plate inside the container collects any talc or spores that penetrate. The assembly is vibrated to simulate mechanical stress; sedimentation plates are incubated and colonies counted.
- Challenge levels: The method defines two challenge concentrations and two vibration exposure times to provide differing degrees of stress on the barrier material.
- Critical parameters:
- Conditioning and test environment: (20 ± 2) °C and (65 ± 5) % relative humidity.
- Vibration: pneumatic ball vibrator operated at 20 800 vibrations per minute.
- Test specimen size and replication: 200 mm × 200 mm pieces; runs include contaminated samples and an uncontaminated control; results are repeated and averaged (arithmetic mean for valid results).
- Sample aliquot: a measured portion of contaminated talc (0.5 g ± 0.1 g) is used per test container.
- Microbiology: use of Bacillus subtilis spores on talc and recovery on TGE agar; plates incubated (35 °C, 24 h) and colony forming units (cfu) counted.
- Equipment: marble base plate, fixing plate, six stainless steel test containers with sedimentation plate slots, pneumatic vibrator, calibrated air flow meter, and Petri dishes with TGE agar.
- Reporting: material identity, test conditions, deviations, contaminant details and statistical result (geometric or arithmetic means as specified).
Applications and users
- Primary users:
- Manufacturers of medical and protective clothing assessing barrier performance for regulatory submissions.
- Accredited test laboratories performing conformity testing to demonstrate compliance with medical device / PPE directives.
- Regulatory and conformity assessment bodies evaluating claims for resistance to microbial penetration.
- Procurement specialists and R&D teams comparing fabrics and constructions for infection control.
- Practical use:
- Assessing gowns, coveralls, cleanroom suits and packaging where dry particle-borne bacteria are a penetration risk.
- Supporting declarations of conformity to EU Directive 93/42/EEC (medical devices) and relevant PPE directives.
Related standards
- EN 13795 (surgical drapes, gowns and clean air suits) - EN ISO 22612 is intended to be used in conjunction with EN 13795 series where specific product testing requirements are defined.
- Annexes in EN ISO 22612 reference relationships to EU Directives 93/42/EEC and 89/686/EEC for conformity assessment.
Keywords: EN ISO 22612:2005, resistance to dry microbial penetration, protective clothing testing, bacteria‑carrying particles, Bacillus subtilis, TGE agar, barrier materials, surgical gowns, clean air suits.
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2005
2EOHND]DYDURYDQMHSUHGSRY]URþLWHOMLLQIHNFLM3UHVNXVQDPHWRGD]DRGSRUQRVW
SURWLSURGLUDQMXVXKLKPLNURERY ,62
Clothing for protection against infectious agents - Test method for resistance to dry
microbial penetration (ISO 22612:2005)
Schutzkleidung gegen infektiöse Agenzien - Prüfverfahren zur Beständigkeit gegen
mikrobielle Penetration im trockenen Zustand (ISO 22612:2005)
Vetements de protection contre les agents infectieux - Méthode d'essai pour la
résistance a la pénétration microbienne seche (ISO 22612:2005)
Ta slovenski standard je istoveten z: EN ISO 22612:2005
ICS:
11.140 Oprema bolnišnic Hospital equipment
13.340.10 Varovalna obleka Protective clothing
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 22612
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2005
ICS 11.140; 13.340.10
English version
Clothing for protection against infectious agents - Test method
for resistance to dry microbial penetration (ISO 22612:2005)
Vêtements de protection contre les agents infectieux - Schutzkleidung gegen infektiöse Agenzien - Prüfverfahren
Méthode d'essai de la résistance à la pénétration zur Beständigkeit gegen mikrobielle Penetration im
microbienne par voie sèche (ISO 22612:2005) trockenen Zustand (ISO 22612:2005)
This European Standard was approved by CEN on 16 August 2004.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions 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 Central Secretariat or to any CEN member.
This European Standard exists in three official 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22612:2005: E
worldwide for CEN national Members.
Contents
page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .5
4 Principle.5
5 Testing conditions.5
6 Equipment .5
6.1 General lay-out.5
6.2 Test containers .6
6.3 Method to infect talc with spores.6
6.3.1 Materials .6
6.3.2 Procedure .7
7 Procedure .7
8 Test report .8
Annex A (informative) Preparation of TGE agar medium.11
A.1 Ingredients.11
A.2 Procedure .11
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC concerning medical devices .12
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 89/686/EEC concerning personal protective equipment .13
Annex ZC (normative) Normative references to international publications with their relevant
European publications .14
Bibliography .15
Foreword
This document (EN ISO 22612:2005) has been prepared by Technical Committee CEN/TC 205 “Non-active
medical devices”, the secretariat of which is held by BSI, in collaboration with Technical Committee ISO/TC 94
“Personal safety - Protective clothing and equipment”.
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 August 2005, and conflicting national standards shall be withdrawn at
the latest by August 2005.
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 Annexes ZA and ZB, which are integral parts of this
document. For international equivalents of cross-references to European Standards see Annex ZC.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
Introduction
There are numerous examples of situations where bacteria may migrate through a barrier material in the dry
state carried by organic or inorganic particles. The dry penetration of bacteria-carrying skin scales through an
operating gown or a clean air suit is one example. Penetration through a packaging material during storage is
another.
This document EN ISO 22612 describes a test method, with the associated equipment, that may be used to
determine a material’s resistance to dry penetration of bacteria on particles in the size range most typical for
human skin scales
1 Scope
This test method provides a means for assessing the resistance to penetration through barrier materials of
bacteria-carrying particles.
NOTE Due to its complexity, this EN ISO 22612 cannot be considered as a useful method for routine quality control
but may suit the needs when a material is assessed for compliance with the requirements of current regulations such as
EU Directive 93/42/EEC.
2 Normative references
The following referenced document is indispensable for the application of this document. For dated references,
only the edition cited applies. For undated references, the latest edition of the referenced document (including
any amendments) applies.
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.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 13795-1:2002 apply.
4 Principle
The test is carried out on test pieces each fixed in a container. In every container except one a portion of talc
contaminated with Bacillus subtilis is poured on the test piece. One container is left uncontaminated as a
control. A sedimentation plate is inserted at the base of each container at a short distance below the test
piece.
The apparatus supporting the containers is then vibrated by a pneumatic ball vibrator. The talc that penetrates
is captured on the sedimentation plate. The sedimentation plates are removed and incubated.
The numbers of colonies produced are counted.
This document specifies two levels of challenge by means of giving two concentrations of bacterial cells on
the talc particles and two times during which the barrier is subjected to vibration. The conditions for testing
differ among product types and will be specified in other standards where this test method is applied such as
in prEN 13795-3.
5 Testing conditions
Condition the samples and test at (20 ± 2) ºC and (65 ± 5) % relative humidity.
6 Equipment
6.1 General lay-out
NOTE See Figure 1.
...
Frequently Asked Questions
EN ISO 22612:2005 is a standard published by the European Committee for Standardization (CEN). Its full title is "Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)". This standard covers: ISO 22612:2005 specifies a test method for assessing the resistance to penetration through barrier materials of bacteria-carrying particles. Due to its complexity, this ISO 22612:2005 cannot be considered as a useful method for routine quality control but may suit the needs when a material is assessed for compliance with the requirements of current regulations such as EU Directive 93/42/EEC.
ISO 22612:2005 specifies a test method for assessing the resistance to penetration through barrier materials of bacteria-carrying particles. Due to its complexity, this ISO 22612:2005 cannot be considered as a useful method for routine quality control but may suit the needs when a material is assessed for compliance with the requirements of current regulations such as EU Directive 93/42/EEC.
EN ISO 22612:2005 is classified under the following ICS (International Classification for Standards) categories: 11.140 - Hospital equipment; 13.340.10 - Protective clothing. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 22612:2005 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/295. 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 ISO 22612:2005 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 ISO 22612:2005 표준은 감염성 물질로부터 보호하기 위한 의복에 대한 테스트 방법을 정의하고 있으며, 특히 박테리아를 함유한 입자의 침투 저항성을 평가하는 데 중점을 둡니다. 이 표준의 주요 목적은 방어 재료를 통한 미생물 침투에 대한 저항성을 실험적으로 측정하는 것으로, 사용자에게는 안전한 보호 의복을 선택할 수 있는 기준을 제공합니다. EN ISO 22612:2005의 강점은 신뢰성 있는 실험 방법론을 바탕으로 하며, 감염 위험이 있는 환경에서 작업하는 개인들에게 필수적인 정보를 제공합니다. 이 표준은 특히 의료 및 생물의학 분야에서 중요한 역할을 하며, 규제 요구사항을 준수하는 재료를 평가하는 데 필요한 정보를 제공합니다. 이는 EU 지침 93/42/EEC와 같은 현행 규정에 적합한 재료 검사를 수행할 수 있는 지침을 제공하여, 사용자의 안전을 보장합니다. 그러나 EN ISO 22612:2005의 복잡성으로 인해 일상적인 품질 관리에 적합한 방법이 아니라는 점은 유의해야 합니다. 이 표준은 보다 높은 수준의 테스트를 요구하며, 따라서 특정 상황에서 재료의 적합성을 평가하고자 하는 경우에 특히 유용합니다. 강화된 테스트 방법은 다양한 환경에서의 의복 성능을 입증할 수 있도록 지원하며, 이는 최종 사용자의 안전을 보다 확실히 할 수 있는 기초를 제공합니다. 결론적으로, SIST EN ISO 22612:2005 표준은 감염성 물질로부터의 보호를 위한 의복의 성능을 평가하는 데 있어 실질적이고 중요한 기준을 제공하며, 적절한 환경에서 올바르게 활용될 경우 사용자의 안전을 효과적으로 보장할 수 있습니다.
Die Norm EN ISO 22612:2005 befasst sich mit der Testmethode zur Bewertung des Widerstands von Schutzkleidung gegen das Eindringen trockener mikrobieller Partikel. Diese Norm ist von zentraler Bedeutung, insbesondere in der heutigen Zeit, in der der Schutz vor infektiösen Agenzien immer wichtiger wird. Der Anwendungsbereich der ISO 22612:2005 ist klar definiert und zielt darauf ab, die Durchdringung von barrierebildenden Materialien durch bakterietragende Partikel zu beurteilen. Diese Fähigkeit zur Bewertung ist für Hersteller von Schutzbekleidung von großer Relevanz, da sie sicherstellen müssen, dass ihre Produkte den hohen Anforderungen des Marktes entsprechen. Eine der wesentlichen Stärken dieser Norm ist, dass sie ein standardisiertes Verfahren bereitstellt, das eine einheitliche Bewertung des Schutzes gegen infektiöse Agens ermöglicht. Damit bietet die ISO 22612:2005 eine wichtige Grundlage für die Einhaltung der geltenden Vorschriften, wie beispielsweise der EU-Richtlinie 93/42/EEC. Die Norm definiert spezifische Testmethoden, die eine objektive Bewertung der Materialeigenschaften ermöglichen und damit die wichtige Compliance mit regulatorischen Anforderungen unterstützen. Es ist jedoch auch zu beachten, dass aufgrund der Komplexität dieser Norm sie nicht als praktikable Methode für die routinemäßige Qualitätskontrolle angesehen werden kann. Dennoch erfüllt sie spezifische Bedürfnisse, wenn Materialien auf ihre Konformität mit aktuellen Vorschriften geprüft werden müssen. Dies macht die Norm zu einem unverzichtbaren Instrument für die Industrie, die in einem sich ständig verändernden regulatorischen Umfeld agiert. Insgesamt bietet die EN ISO 22612:2005 eine umfassende und relevante Grundlage zur Beurteilung der Widerstandsfähigkeit von Schutzkleidung gegen mikrobielles Eindringen und wird somit als entscheidend in der Entwicklung und Prüfung von Schutzmaterialien betrachtet.
The EN ISO 22612:2005 standard provides a critical framework for evaluating the resistance of barrier materials in clothing against dry microbial penetration by bacteria-carrying particles. This standard delineates a specific test method that is essential for ensuring the protective capabilities of textiles used in environments where exposure to infectious agents is a concern. One of the notable strengths of ISO 22612:2005 is its ability to establish rigorous performance criteria that manufacturers must meet when designing protective clothing. This is particularly relevant in the context of compliance with current regulations such as the EU Directive 93/42/EEC, which necessitates strict adherence to safety standards in medical and healthcare settings. The standard's precise focus on the resistance to penetration ensures that the materials used are adequately tested and validated, offering an assurance of safety for end users. Moreover, while the complexity of the test method outlined in ISO 22612:2005 means it may not be suitable for routine quality control, it serves a significant purpose in material assessment. Its deployment in the evaluation of new protective fabrics or clothing intended for medical or laboratory use exemplifies its relevance in the continuous improvement and effectiveness of protective clothing technologies. By adhering to this standard, producers can better align their products with regulatory requirements and enhance confidence in their performance against infectious agents. In summary, the EN ISO 22612:2005 standard is a vital tool for manufacturers involved in the production of protective clothing, reinforcing the importance of rigorous testing methodologies designed to combat microbial threats effectively. Its relevance in ensuring the safety and reliability of materials in high-risk environments cannot be overstated, making it an indispensable resource within the industry.
La norme EN ISO 22612:2005 représente une avancée significative dans le domaine des vêtements de protection contre les agents infectieux. Son objectif principal est d’établir une méthode de test pour évaluer la résistance à la pénétration des particules bactériennes à travers des matériaux barrières. C'est un instrument crucial pour les fabricants de vêtements de protection, car elle définit des critères de performance qui doivent être respectés pour assurer une protection adéquate. L'un des points forts de cette norme est sa capacité à fournir une évaluation rigoureuse des matériaux, ce qui est essentiel dans le contexte actuel où la protection contre les agents pathogènes est primordiale. La méthode décrite dans l'ISO 22612:2005 permet de tester spécifiquement la résistance à la pénétration sèche des micro-organismes, offrant une évaluation pertinente pour les vêtements destinés à un usage médical ou industriel. Cependant, il est important de noter que, en raison de sa complexité, la norme ISO 22612:2005 ne doit pas être utilisée comme méthode de contrôle qualité routinier. Elle est plutôt adaptée lorsque les matériaux sont évalués pour leur conformité aux exigences des réglementations en vigueur, telles que la Directive 93/42/EEC de l'UE. Cela souligne la pertinence de cette norme pour assurer la sécurité des utilisateurs tout en respectant les normes réglementaires strictes. En somme, la norme SIST EN ISO 22612:2005 se révèle être un outil essentiel pour les professionnels du secteur, permettant d'assurer que les vêtements de protection utilisés contre les agents infectieux répondent à des critères de performance fiables et validés. Sa mise en œuvre contribue ainsi à renforcer la sécurité dans les environnements potentiellement exposés aux risques infectieux.
SIST EN ISO 22612:2005は、感染性物質に対する防護服の標準化文書であり、特に乾燥した微生物の侵入に対する抵抗性を評価する試験方法に焦点を当てています。この標準は、バリア材料を通じて細菌を運ぶ粒子の侵入抵抗性を評価するための試験手法を明確に規定しており、特に医療分野や感染症対策において重要な役割を果たします。 この標準の強みは、科学的根拠に基づいた試験方法を提供し、異なる素材の耐性を客観的に評価できる点です。これにより、製造業者や規制当局は、感染リスクを最小限に抑えるための効果的な防護服の設計及び評価を行うことができます。また、ISO 22612:2005は、EU指令93/42/EECの要求事項に適合するための材料評価に適した試験方法として位置付けられています。 ただし、この標準はその複雑さから、日常的な品質管理のための有用な方法とは言えません。したがって、使用者はこの試験方法を特定の規制要件の遵守を得るために適用する際には、慎重な検討が必要です。全体として、SIST EN ISO 22612:2005は、感染性物質に対する防護服の性能評価において非常に重要な役割を果たし、業界全体の安全性基準の向上に寄与しています。
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