EN 13726-4:2003
(Main)Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
This European Standard describes a test method for measuring aspects of conformability of primary wound dressings.
Nichtaktive Medizinprodukte - Prüfverfarhen für primäre Verbandstoffe (Wundauflagen) - Teil 4: Anpassungsfähigkeit
Dispositifs médicaux non-actifs - Méthodes d'essai pour les pansements en contact avec la plaie - Partie 4: Conformabilité
La présente Norme européenne décrit une méthode d'essai permettant de mesurer les performances de conformabilité des pansements primaires en contact avec la plaie.
Neaktivni medicinski pripomočki – Preskusne metode za sanitetni material za primarno oskrbo rane - 4. del: Ustreznost
General Information
- Status
- Withdrawn
- Publication Date
- 22-Apr-2003
- 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
- 19-Jan-2023
Frequently Asked Questions
EN 13726-4:2003 is a standard published by the European Committee for Standardization (CEN). Its full title is "Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability". This standard covers: This European Standard describes a test method for measuring aspects of conformability of primary wound dressings.
This European Standard describes a test method for measuring aspects of conformability of primary wound dressings.
EN 13726-4:2003 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 13726-4:2003 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 13726-4:2003 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)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Nichtaktive Medizinprodukte - Prüfverfarhen für primäre Verbandstoffe (Wundauflagen) - Teil 4: AnpassungsfähigkeitDispositifs médicaux non-actifs - Méthodes d'essai pour les pansements en contact avec la plaie - Partie 4: ConformabilitéNon-active medical devices - Test methods for primary wound dressings - Part 4: Conformability11.120.20Sanitetni materiali, obveze in kompreseWound dressings and compressesICS:Ta slovenski standard je istoveten z:EN 13726-4:2003SIST EN 13726-4:2003en01-september-2003SIST EN 13726-4:2003SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13726-4April 2003ICS 11.120.20English versionNon-active medical devices - Test methods for primary wounddressings - Part 4: ConformabilityDispositifs médicaux non-actifs - Méthodes d'essai pour lespansements en contact avec la plaie - Partie 4:ConformabilitéNichtaktive Medizinprodukte - Prüfverfarhen für primäreVerbandstoffe (Wundauflagen) - Teil 4:AnpassungsfähigkeitThis European Standard was approved by CEN on 21 February 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 13726-4:2003 ESIST EN 13726-4:2003
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EN 13726-4:2003 표준은 비활성 의료기기에 대한 주요 상처 드레싱의 적합성을 측정하기 위한 시험 방법을 설명합니다. 이 표준의 범위는 상처 드레싱의 적합성을 평가하는 데 매우 중요하며, 이를 통해 의료 전문가와 제조업체가 제품의 신뢰성과 효능을 보장할 수 있도록 지원합니다. EN 13726-4:2003의 주요 강점은 정량적이고 재현 가능한 방법으로 드레싱의 적합성을 평가할 수 있다는 점입니다. 이는 다양한 환경에서 드레싱의 성능을 비교하고 최적의 선택을 할 수 있게 해줍니다. 또한, 이 표준은 유럽 전역에서 통일된 평가 기준을 제공하므로, 국제적인 품질 기준에 부합하는 제품 개발에 기여할 수 있습니다. 이 표준의 적합성은 다양한 비활동적 의료기기의 안전성과 효율성을 높이는 데 크게 기여합니다. EN 13726-4:2003은 상처 치료에서 필수적인 요소인 드레싱의 물리적 특성을 평가함으로써, 사용자에게 보다 안전하고 효과적인 원단 제품이 제공될 수 있도록 합니다. 의료 기기 분야에서의 규정 준수에 더욱 중점을 두게 되는 현대 사회에서, 이 표준은 중요한 참고자료로 자리 잡고 있습니다.
SIST EN 13726-4:2003は、非活性医療機器における主な創傷被覆材の適合性に関するテスト方法を定めた欧州標準です。この標準の範囲は、創傷被覆材の適合性評価に重点を置いており、創傷の治療において非常に重要な役割を果たす要素を測定します。 主な強みとして、この標準は創傷被覆材がどの程度の適合性を持っているかを科学的な手法で評価することができる点が挙げられます。具体的には、被覆材が皮膚や創傷に対してどれだけ適切にフィットするかを測るための詳細なガイドラインを提供しています。このような測定は、医療現場において患者の快適さや創傷治癒プロセスの向上に寄与します。 さらに、この標準は、創傷被覆材の一貫した品質を確保するためにも重要です。適合性が高い創傷被覆材は、機能的な利点があり、創傷管理における成果を大きく向上させる可能性があります。特に、異なるメーカーの製品間での比較が可能であるため、医療従事者や患者にとっても選択肢を広げることができます。 SIST EN 13726-4:2003は、臨床における創傷治療の向上を目的とした重要な基準として位置付けられています。この標準に基づくテスト方法は、非活性医療機器における創傷被覆材の品質を測るための基本的な枠組みを提供し、医療業界全体における適合性の重要性を強調するものです。
The standard EN 13726-4:2003, titled "Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability," provides a crucial framework for assessing an essential characteristic of primary wound dressings: their conformability. This European Standard specifically outlines testing methodologies that manufacturers and regulators can use to evaluate how well wound dressings mold and adhere to various anatomical contours, which directly impacts the effectiveness of wound management. One of the notable strengths of this standard is its comprehensive approach to defining and quantifying conformability. By establishing clear test protocols, EN 13726-4:2003 ensures consistency and reliability in performance evaluation, which is fundamental for device quality assurance and regulatory compliance. This ensures that healthcare providers can trust the products they use in clinical settings, thereby enhancing patient safety and treatment outcomes. Furthermore, the relevance of this standard cannot be overstated in the context of medical device regulation. As the healthcare industry increasingly prioritizes effective wound care solutions, understanding the conformability of wound dressings becomes paramount. This standard supports innovation in product development by providing a benchmark for improvement, encouraging manufacturers to strive for higher standards in their designs. In summary, SIST EN 13726-4:2003 stands out as a vital reference for testing primary wound dressings, reinforcing the importance of conformability in wound care. Its rigorous testing methodologies and emphasis on quality make it indispensable for both manufacturers and healthcare professionals aiming to ensure that wound dressings meet stringent performance criteria.
Die Norm EN 13726-4:2003 bietet einen klar definierten Rahmen für die Bewertung der Konformierbarkeit von primären Wundverbänden. Dieser Standard ist besonders relevant für Hersteller und Prüfstellen im Bereich nicht aktiver medizinischer Geräte, da er spezifische Testmethoden beschreibt, die sicherstellen, dass Wundverbände effektiv an die Form des Wundbereichs angepasst werden können. Eine der Stärken dieser Norm liegt in der systematischen Herangehensweise zur Messung der Konformierbarkeit, die es den Unternehmen ermöglicht, ihre Produkte hinsichtlich der Nutzerfreundlichkeit und der therapeutischen Wirksamkeit zu bewerten. Die Festlegung einheitlicher Prüfstandards trägt zudem zur Qualitätssicherung und zur Verbesserung der Vergleichbarkeit zwischen verschiedenen Produkten bei. Die Norm nimmt in der heutigen Zeit eine zentrale Rolle im Gesundheitswesen ein, da sie die Grundlage für die Entwicklung sicherer und effektiver Wundversorgungsprodukte bildet. durch die Einführung standardisierter Testmethoden wird nicht nur die Produktleistung verbessert, sondern auch das Vertrauen der Endverbraucher in die Qualität der Wundverbände gestärkt. Insgesamt ist die EN 13726-4:2003 von großer Bedeutung für die Optimierung der Wundversorgung, da sie dazu beiträgt, dass Produkte auf dem Markt den hohen Anforderungen an Konformierbarkeit und Funktionalität gerecht werden.
La norme SIST EN 13726-4:2003 est un document essentiel qui se concentre sur les dispositifs médicaux non actifs, en particulier les pansements de plaies primaires. Son champ d'application est précis et bien défini, abordant les méthodes d'essai pour mesurer la conformabilité de ces dispositifs. La définition claire et les critères de conformité établis permettent d'assurer une évaluation rigoureuse des pansements, garantissant qu'ils répondent aux exigences cliniques strictes. Une des forces majeures de cette norme réside dans sa capacité à normaliser les processus de test, ce qui facilite la comparaison des performances entre différents produits. En fournissant des directives uniformes, elle améliore non seulement la qualité des soins aux patients, mais aussi la confiance des professionnels de la santé dans l'utilisation de ces dispositifs. De plus, la norme aborde des aspects critiques tels que le confort et l'adaptabilité des pansements sur différentes surfaces de la peau, ce qui est particulièrement pertinent dans le contexte des soins des plaies. Cette attention portée à la conformabilité contribue à la réduction des complications et à l'amélioration des résultats cliniques. En somme, la SIST EN 13726-4:2003 est une norme d'une grande pertinence pour les fabricants et les utilisateurs de dispositifs médicaux, jouant un rôle clé dans l'amélioration de la qualité des soins et dans la standardisation des méthodes de test des pansements de plaies.
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