SIST 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- Withdrawn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
- 31-Aug-2003
- Withdrawal Date
- 08-Feb-2024
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 9900 - Withdrawal (Adopted Project)
- Start Date
- 22-Jan-2024
- Due Date
- 14-Feb-2024
- Completion Date
- 09-Feb-2024
Relations
- Effective Date
- 01-Mar-2024
Frequently Asked Questions
SIST EN 13726-4:2003 is a standard published by the Slovenian Institute for Standardization (SIST). 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.
SIST 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.
SIST EN 13726-4:2003 has the following relationships with other standards: It is inter standard links to SIST EN 13726:2024. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST 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.
You can purchase SIST EN 13726-4:2003 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 SIST standards.
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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SIST EN 13726-4:2003 표준은 비활성 의료기기에 대한 테스트 방법을 정립하여 주요 상처 드레싱의 적합성을 측정하는 데 중점을 두고 있습니다. 이 표준의 주요 범위는 기본 상처 드레싱의 적합성을 평가하기 위한 정확한 테스트 방법을 제공합니다. 이 표준의 강점은 명확한 테스트 프로세스를 제시함으로써 의료기기 제조사에게 품질 관리 기준을 설정할 수 있는 기초를 마련한다는 점입니다. 적합성 측정을 통해 다양한 소재와 디자인의 드레싱이 환자에게 어떻게 적합하게 작용하는지를 파악할 수 있으며, 이는 임상 현장에서의 효과성 증대에 기여합니다. 또한, SIST EN 13726-4:2003은 유럽 내에서의 일관된 평가 기준을 제공함으로써, 의료 기기 품질이 향상되고, 소비자 안전이 보장됩니다. 이 표준의 적용은 상처 치료의 성공률을 높이고, 환자의 회복 속도를 개선하는 데 도움을 줄 것입니다. 따라서 이 문서는 현대 의료환경에서 비할 데 없는 중요성을 지닌다 할 수 있습니다.
SIST EN 13726-4:2003は、非アクティブ医療機器に関する重要な標準で、特に一次創傷被覆材の適合性に焦点を当てています。この標準は、一次創傷被覆材の適合性を測定するための試験方法を詳細に定義しており、その適用範囲は幅広い医療分野にわたります。 この標準の強みは、創傷被覆材の選定における科学的根拠を提供する点にあります。具体的には、試験方法は客観的なデータを得ることを可能にし、製品の効果や使用感を評価する上で信頼性の高い基準となります。また、適合性の測定においては、異なるタイプの被覆材の比較が容易になり、医療従事者が患者に最適な製品を選定する際の助けとなります。 さらに、SIST EN 13726-4:2003はEUの医療規制において重要な役割を果たしており、医療機器の安全性と効果を保証するためには必要不可欠な標準です。この標準の遵守は、医療機関や製造者が患者の健康と安全を最優先に考えることを確実にし、医療の質の向上に寄与します。 全体として、SIST EN 13726-4:2003は、一次創傷被覆材の適合性を評価するための強力な指針を提供しており、医療機器の安全性と性能の確保において非常に関連性の高い文書です。
The SIST EN 13726-4:2003 standard is a pivotal document in the realm of non-active medical devices, specifically addressing the test methods for primary wound dressings with a focus on conformability. Its scope is well-defined, providing clear guidelines for measuring the conformability aspects of primary wound dressings, which is crucial for their effective application in clinical settings. One of the notable strengths of this standard is its comprehensive approach to defining the parameters for testing conformability. It ensures that manufacturers have a consistent and reliable method for assessing how well wound dressings can adapt to the contours of the skin. This adaptability is essential, as it can significantly affect the healing process and overall patient comfort. Additionally, the relevance of SIST EN 13726-4:2003 cannot be overstated, particularly in the context of ongoing advancements in wound care technology and materials. As medical professionals increasingly rely on evidence-based practices, the standard offers a crucial benchmark that helps improve the efficacy and safety of wound dressings. By adhering to these standardized test methods, manufacturers can enhance the quality of their products, contributing to better patient outcomes in wound management. In summary, the SIST EN 13726-4:2003 standard is indispensable in the evaluation of primary wound dressings, ensuring that they meet high standards of conformability. Its methodical approach not only aids manufacturers in producing superior products but also supports healthcare professionals in delivering optimal care to patients.
La norme SIST EN 13726-4:2003 constitue un document essentiel pour l'évaluation des dispositifs médicaux non actifs, spécifiquement en ce qui concerne les méthodes d'essai pour les pansements primaires. Le champ d'application de cette norme se concentre sur la mesure des aspects de la conformabilité des pansements, un critère crucial pour assurer le bon fonctionnement et l'efficacité des soins. L'un des principaux points forts de cette norme réside dans sa méthodologie détaillée qui permet d'effectuer des tests standardisés sur la conformabilité des pansements. Cela garantit que les produits évalués répondent à des critères de performance uniformes, ce qui est particulièrement important pour la sécurité et le confort des patients. La norme propose également des protocoles clairs pour la réalisation des essais, ce qui facilite leur mise en œuvre par les fabricants et les organismes de réglementation. En outre, la pertinence de la norme SIST EN 13726-4:2003 est mise en avant par son alignement avec les exigences réglementaires actuelles et les attentes du marché. Dans un secteur où l'innovation est constante et où la qualité des dispositifs médicaux est primordiale, cette norme sert de référence pour les fabricants et contribue à l’amélioration continue des produits de santé. En résumé, la SIST EN 13726-4:2003 se révèle être une norme solide et nécessaire pour l’industrie des pansements, garantissant que les nouveaux produits sont testés de manière rigoureuse pour leur conformabilité, renforçant ainsi la confiance des professionnels de la santé et des patients dans l'utilisation de ces dispositifs.
Der Standard SIST EN 13726-4:2003 beschäftigt sich mit nicht-aktiven Medizinprodukten und legt spezifische Testmethoden für die Konformierbarkeit von primären Wundverbänden fest. Der Umfang dieser Norm ist besonders wichtig, da er eine einheitliche Methode zur Bewertung der Konformierbarkeit von Wundverbänden bietet, was für die Sicherheit und Effektivität von medizinischen Anwendungen entscheidend ist. Ein herausragendes Merkmal des Standards ist die klare und präzise Beschreibung der Testmethoden, die es Herstellern ermöglicht, die Konformierbarkeit ihrer Produkte systematisch zu überprüfen. Dies trägt zur Gewährleistung der Qualität bei und stellt sicher, dass die Wundverbände optimal an die Bedürfnisse der Patienten angepasst sind. Der Standard fördert die Entwicklung von Produkten, die sowohl effektiv als auch komfortabel in der Anwendung sind. Die Relevanz der SIST EN 13726-4:2003 Norm kann nicht hoch genug eingeschätzt werden, da sie nicht nur die Regulierung von Wundverbänden unterstützt, sondern auch einen Beitrag zur gesamtheitlichen Patientenversorgung leistet. Durch die Etablierung verbindlicher Testmethoden wird sichergestellt, dass nur Produkte, die strengen Qualitätskriterien entsprechen, auf den Markt gelangen. Insgesamt zeigt der Standard SIST EN 13726-4:2003, wie wichtig es ist, Qualität und Sicherheit in der medizinischen Produktentwicklung zu priorisieren und stellt eine essenzielle Grundlage dar, um die Anforderungen an primäre Wundverbände effektiv zu erfüllen.
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