EN 13726-2:2002
(Main)Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
Part 2 of EN 13726 describes test methods recommended for the evaluation of moisture vapour transmission rate of permeable film primary wound dressings.
Prüfverfahren für primäre Verbandstoffe (Wundauflagen) - Teil 2: Feuchtigkeitsdurchdringungsrate durchlässiger Folienverbände
Teil 2 von EN 13726 legt Prüfverfahren fest, die für die Beurteilung der Feuchtigkeitstransportrate durchlässiger Folienverbände empfohlen werden.
Méthodes d'essai pour les pansements primaires en contact avec la plaie - Partie 2: Perméabilité à la vapeur d'eau des pansements comprenant un film perméable
La partie 2 de l'EN 13726 décrit les méthodes d'essai recommandées pour l'évaluation du taux de transmission de vapeur d'eau des pansements avec film primaires perméables.
Preskusne metode za sanitetni material za primarno oskrbo rane - 2. del: Hitrost prepustnosti za vodne pare prepustnih filmskih oblog
General Information
- Status
- Withdrawn
- Publication Date
- 19-Mar-2002
- Withdrawal Date
- 13-Apr-2025
- Technical Committee
- CEN/TC 205 - Non-active medical devices
- Drafting Committee
- CEN/TC 205/WG 9 - Test methods for materials for use in compresses
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 20-Sep-2023
- Completion Date
- 14-Apr-2025
Relations
- Effective Date
- 25-Sep-2019
Frequently Asked Questions
EN 13726-2:2002 is a standard published by the European Committee for Standardization (CEN). Its full title is "Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings". This standard covers: Part 2 of EN 13726 describes test methods recommended for the evaluation of moisture vapour transmission rate of permeable film primary wound dressings.
Part 2 of EN 13726 describes test methods recommended for the evaluation of moisture vapour transmission rate of permeable film primary wound dressings.
EN 13726-2:2002 is classified under the following ICS (International Classification for Standards) categories: 11.120.20 - Wound dressings and compresses. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 13726-2:2002 has the following relationships with other standards: It is inter standard links to EN 13726:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13726-2:2002 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.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2002
Preskusne metode za sanitetni material za primarno oskrbo rane - 2. del: Hitrost
prepustnosti za vodne pare prepustnih filmskih oblog
Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of
permeable film dressings
Prüfverfahren für primäre Verbandstoffe (Wundauflagen) - Teil 2:
Feuchtigkeitsdurchdringungsrate durchlässiger Folienverbände
Méthodes d'essai pour les pansements primaires en contact avec la plaie - Partie 2:
Perméabilité a la vapeur d'eau des pansements comprenant un film perméable
Ta slovenski standard je istoveten z: EN 13726-2:2002
ICS:
11.120.20 Sanitetni materiali, obveze in Wound dressings and
komprese compresses
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 13726-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2002
ICS 11.120.20
English version
Test methods for primary wound dressings - Part 2: Moisture
vapour transmission rate of permeable film dressings
Méthodes d'essai pour les pansements primaires en Prüfverfahren für primäre Verbandstoffe (Wundauflagen) -
contact avec la plaie - Partie 2: Perméabilité à la vapeur Teil 2: Feuchtigkeitsdurchdringungsrate durchlässiger
d'eau des pansements comprenant un film perméable Folienverbände
This European Standard was approved by CEN on 22 February 2002.
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 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 translation
under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, 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
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13726-2:2002 E
worldwide for CEN national Members.
Contents
page
Foreword.3
Introduction .4
1 Scope .5
2 Terms and definitions.5
3 Test methods for moisture vapour transmission rate (MVTR).5
3.1 Test conditions .5
3.2 MVTR of a wound dressing when in contact with water vapour.5
3.3 MVTR of a wound dressing when in contact with liquid .7
Foreword
This document EN 13726-2:2002 has been prepared by Technical Committee CEN/TC 205 "Non-active medical
devices", the secretariat of which is held by BSI.
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 September 2002, and conflicting national standards shall be withdrawn at the
latest by September 2002.
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).
EN 13726 will consist of the following parts under the general title Test methods for primary wound dressings:
- Part 1 : Aspects of absorbency
- Part 2 : Moisture vapour transmission rate of permeable film dressings
- Part 3 : Waterproofness
- Part 4 : Conformability
- Part 5 : Bacterial barrier properties
- Part 6 : Odour control
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, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,
Sweden, Switzerland and the United Kingdom.
Introduction
EN 13726 specifies test methods and does not contain performance requirements. Part 2 of this standard
describes test methods for the determination of the moisture vapour transmission rate of permeable film dressings.
Test methods for other aspects of primary wound dressings are described in other parts of EN 13726.
1 Scope
Part 2 of EN 13726 describes test methods recommended for the evaluation of moisture vapour transmission rate
of permeable film primary wound dressings.
2 Terms and definitions
For the purposes of this standard the following terms and definitions apply.
2.1
moisture vapour transmission rate (MTVR)
permeability of materials to the passage of water molecules from the skin contact side to the external atmosphere
under controlled conditions of humidity and temperature
2.2
permeable wound dressing
wound dressing that permits water vapour to pass from the skin or wound through it to the external atmosphere
2.3
primary wound dressing
material or combination of materials, in any shape, form or size that is intended to remain in d
...
La norme EN 13726-2:2002, intitulée "Méthodes d'essai pour les pansements primaires de plaies - Partie 2 : Taux de transmission de vapeur d'eau des pansements films perméables", se concentre sur les méthodes d'évaluation essentielles des pansements films perméables. Son champ d'application est spécifiquement défini pour mesurer le taux de transmission de la vapeur d'eau, un paramètre crucial dans la conception et l'utilisation des dispositifs de soins des plaies. Parmi les points forts de cette norme, on peut souligner la rigueur des méthodes d'essai proposées, qui fournissent des résultats fiables et reproductibles. Cela garantit que les fabricants et les utilisateurs des pansements peuvent se fier aux données fournies pour sélectionner les produits les plus adéquats en fonction des besoins cliniques. De plus, l'importance de la transmission de vapeur d'eau est renforcée, puisqu'elle joue un rôle clé dans la gestion de l'humidité autour de la plaie, influençant par conséquent la cicatrisation et le confort du patient. La pertinence de la norme EN 13726-2:2002 est indéniable, car elle répond aux exigences croissantes du marché en matière de sécurité et d'efficacité des dispositifs médicaux. En standardisant les méthodes d'évaluation, cette norme contribue non seulement à assurer la qualité des pansements primaires de plaies, mais elle facilite également la comparaison entre différents produits, offrant ainsi aux professionnels de la santé des outils efficaces pour prendre des décisions éclairées en matière de soins des plaies. En résumé, la norme SIST EN 13726-2:2002 est un document fondamental qui définit des méthodologies robustes pour tester le taux de transmission de vapeur d'eau, assurant ainsi une meilleure compréhension et une amélioration continue des pansements films perméables dans le secteur des soins de santé.
SIST EN 13726-2:2002 문서는 투습성 필름 드레싱의 수분 증기 전송률을 평가하기 위한 테스트 방법을 규정하고 있습니다. 이 표준은 1차 상처 드레싱의 평가를 위한 중요한 지침을 제공하며, 특히 의료분야에서 드레싱의 성능을 질적으로 평가하는 데 필수적인 역할을 합니다. EN 13726-2의 주요 강점 중 하나는 투습성 필름 드레싱의 물리적 속성을 체계적으로 분석할 수 있는 신뢰성 있는 방법론을 제공한다는 점입니다. 이는 환자 치료에서 드레싱의 선택과 사용에 있어 과학적인 근거를 마련해 줍니다. 또한, 수분 증기 전송률의 측정은 드레싱이 환자의 상처 치유에 미치는 영향을 직관적으로 이해하는 데 있어 필수적입니다. 이 표준은 여러 국가에서 광범위하게 인정되고 있으며, 의료 기기 규제 준수를 위한 필수 요건으로 여겨지고 있습니다. 따라서 EN 13726-2는 제조업체들이 제품을 평가하고 개선하는 데 필요한 기준을 제공하며, 상처 치료의 효율성을 높이는 데 중대한 기여를 합니다. 궁극적으로, 이 표준은 의사와 의료 전문가들이 환자 치료에 있어 더 나은 결정을 내릴 수 있도록 지원합니다.
Die Norm SIST EN 13726-2:2002 bietet eine detaillierte Beschreibung der Testmethoden zur Bewertung der Durchlässigkeit von dampfdurchlässigen Filmdressings. Besonders hervorzuheben ist der spezifische Fokus auf die Bestimmung der Wasserverdampfungstransmissionsrate, die für die Leistung und den Einsatzbereich von primären Wundverbänden von entscheidender Bedeutung ist. Diese Norm ist eine klare und präzise Anleitung, die den Herstellern und Fachleuten im Gesundheitswesen hilft, die Eignung ihrer Produkte effektiv zu beurteilen. Ein wesentlicher Aspekt der Norm ist ihr praktischer Ansatz zur Evaluierung der Eigenschaften von permeablen Filmdressings. Die definierten Testmethoden sind einfach nachvollziehbar und ermöglichen eine konsistente Durchführung, was zu zuverlässigen und reproduzierbaren Ergebnissen führt. Dies stärkt nicht nur die Produktqualität, sondern auch das Vertrauen der Anwender in die Wirksamkeit der verwendeten Wundverbände. Die Relevanz von SIST EN 13726-2:2002 bleibt in der aktuellen Diskussion um moderne Wundversorgungstechniken unbestritten. Durch die Festlegung klarer Kriterien für die Feuchtigkeitskontrolle unterstützt die Norm das Ziel, die Heilung von Wunden zu optimieren und Komplikationen zu vermindern. Insbesondere für Fachleute, die in der Entwicklung und Anwendung von Wundversorgungsprodukten tätig sind, stellt diese Norm ein unverzichtbares Werkzeug dar, um die therapeutischen Ergebnisse zu maximieren. Zusammenfassend lässt sich sagen, dass die Norm SIST EN 13726-2:2002 nicht nur die wissenschaftliche Basis für qualitative Tests von Filmdressings stellt, sondern auch einen bedeutenden Beitrag zur Verbesserung der Patientensicherheit und Behandlungsergebnisse leistet. Ihre Anwendung wird als wesentlich erachtet, um die Standards in der Wundversorgung kontinuierlich zu heben und innovative Lösungen voranzutreiben.
SIST EN 13726-2:2002は、透湿性フィルムドレッシングの一次傷バンデージの湿気蒸気伝達率を評価するための試験方法を定義します。この規格の範囲は非常に明確で、透湿性フィルムの特性を測定するために必要な基準を提供することにより、医療現場での適切な傷管理を支援します。 この標準の強みは、その科学的根拠に基づいた試験方法にあります。試験法は、透湿性フィルムドレッシングがどのように湿気を調節するかを詳しく分析し、使用時の快適性や創傷の治癒に与える影響を評価する上で不可欠です。特に、湿気蒸気伝達率は、創傷環境の管理において重要な要素であり、適切に選定されたドレッシング材が治癒過程を促進することを確保します。 さらに、SIST EN 13726-2:2002は、医療従事者が使用する際の統一された基準を提供するため、医療機器の市場においてもその関連性が高いです。この規格の導入により、製品間の性能比較が可能になり、消費者や医療提供者にとっての選択肢を広げる役割も果たしています。 全体として、SIST EN 13726-2:2002は、透湿性フィルムドレッシングの評価において重要な役割を果たし、医療現場における創傷管理の質を向上させるための基準を提供しています。
The standard EN 13726-2:2002 is a crucial document that outlines test methods specifically aimed at assessing the moisture vapour transmission rate (MVTR) of permeable film primary wound dressings. Its scope is clearly defined, focusing on rigorous evaluation processes that ensure the effectiveness of these medical products in maintaining an optimal environment for wound healing. One of the primary strengths of this standard is its comprehensive approach to testing, which facilitates uniformity and consistency across various manufacturers and products. By establishing a reliable method for measuring MVTR, it helps in comparing the performance of different wound dressings, ultimately leading to better clinical outcomes. Moreover, the standard underscores the importance of moisture management in wound care, which is vital for preventing complications such as infection or prolonged healing times. The relevance of EN 13726-2:2002 in today’s healthcare landscape cannot be overstated. As clinicians increasingly rely on effective wound management solutions, having standardized test methods ensures that healthcare professionals can make informed choices regarding the wound dressings they use. This standard serves as a key reference for regulatory bodies, researchers, and manufacturers, fostering innovation while maintaining safety and efficacy. In summary, EN 13726-2:2002 provides a solid framework for evaluating the performance of permeable film dressings, with its focus on moisture vapour transmission rates standing out as particularly important in advancing wound care practices.
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