ISO 8600-4:2023
(Main)Endoscopes - Medical endoscopes and endotherapy devices - Part 4: Determination of maximum width of insertion portion
Endoscopes - Medical endoscopes and endotherapy devices - Part 4: Determination of maximum width of insertion portion
This document specifies a method of measurement of the maximum insertion portion width of medical endoscopes and certain endoscopic accessories.
Endoscopes — Endoscopes médicaux et dispositifs d'endothérapie — Partie 4: Détermination de la largeur maximale de la partie insérée
General Information
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Overview
ISO 8600-4:2023 is an international standard developed by ISO that defines a precise method for measuring the maximum width of the insertion portion of medical endoscopes and certain endoscopic accessories. This standard ensures consistency and accuracy in the dimensional assessment of both flexible and rigid endoscopes as well as capsule endoscopes. By providing a clear measurement protocol, ISO 8600-4:2023 supports improved design verification, quality control, regulatory compliance, and safety in endoscopic medical devices.
Key Topics
- Scope: Specifies measurement methods for the maximum insertion portion width of medical endoscopes and related endoscopic tools.
- Measurement Conditions: Testing should occur in environments between 15°C and 35°C, using instruments with accuracy to at least 0.05 mm (e.g., vernier calipers). For peripheral length in French size units, accuracy of 0.5 mm is required.
- Measurement Method for Flexible and Rigid Endoscopes:
- Maximum diameter is measured as the largest circumscribed circle perpendicular to the insertion axis.
- Flexible insertion portions must be measured straight.
- Measurements include diameter indication in millimeters and French size calculation (1 Fr = 1/3 mm diameter) with adaptations for non-circular cross-sections.
- Detachable hoods are measured both with and without attached to account for dimensional changes.
- Measurement Method for Capsule Endoscopes:
- Maximum diameter is taken perpendicular to the longer axis of the capsule, ensuring precise assessment of compact endotherapy devices.
Applications
ISO 8600-4:2023 is critical for:
- Medical Device Manufacturers: To standardize product specifications and ensure endoscope dimensions align with design requirements and safety standards.
- Quality Assurance Teams: For routine inspection and verification of the insertion portion width, guaranteeing device consistency and patient safety.
- Regulatory Compliance: Providing documented measurement methodologies aids in meeting regulatory demands in various global markets.
- Healthcare Providers and Procurement: Assisting clinicians and purchasing agents in selecting devices that meet size criteria suited for patient safety and procedural effectiveness.
Related Standards
- ISO 8600-1: General requirements for medical endoscopes and endotherapy devices, establishing foundational definitions and requirements.
- ISO 8600-6: Vocabulary related to medical endoscopes, ensuring terminology consistency among stakeholders.
- Additional parts of the ISO 8600 series cover other aspects of endoscope performance and safety, supporting comprehensive standardization across endoscopic technologies.
Keywords: ISO 8600-4:2023, medical endoscopes, insertion portion width, measurement method, flexible endoscope, rigid endoscope, capsule endoscope, French size, quality assurance, regulatory compliance, endotherapy devices, medical device standards, insertion diameter measurement.
Frequently Asked Questions
ISO 8600-4:2023 is a standard published by the International Organization for Standardization (ISO). Its full title is "Endoscopes - Medical endoscopes and endotherapy devices - Part 4: Determination of maximum width of insertion portion". This standard covers: This document specifies a method of measurement of the maximum insertion portion width of medical endoscopes and certain endoscopic accessories.
This document specifies a method of measurement of the maximum insertion portion width of medical endoscopes and certain endoscopic accessories.
ISO 8600-4:2023 is classified under the following ICS (International Classification for Standards) categories: 11.040.55 - Diagnostic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 8600-4:2023 has the following relationships with other standards: It is inter standard links to ISO 8600-4:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase ISO 8600-4:2023 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 ISO standards.
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 8600-4
Third edition
2023-01
Endoscopes — Medical endoscopes
and endotherapy devices —
Part 4:
Determination of maximum width of
insertion portion
Endoscopes — Endoscopes médicaux et dispositifs d'endothérapie —
Partie 4: Détermination de la largeur maximale de la partie insérée
Reference number
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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or ISO’s member body in the country of the requester.
ISO copyright office
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Published in Switzerland
ii
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test conditions .1
4.1 Test environments . 1
4.2 Accuracy of measuring instruments . 1
5 Method of measurement .2
5.1 Flexible and rigid endoscope . 2
5.1.1 General . 2
5.1.2 Diameter indication, d . 2
5.1.3 French size indication, Fr . . 2
5.2 Capsule endoscope . 3
iii
Foreword
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ISO 8600-4:2023 serves as a pivotal standard within the field of medical endoscopy, specifically focusing on the determination of the maximum width of the insertion portion of medical endoscopes and related endotherapy devices. This document establishes a robust methodology for the measurement of this critical parameter, thereby enhancing the compatibility and effectiveness of endoscopic instruments in clinical applications. One of the primary strengths of ISO 8600-4:2023 lies in its detailed and precise approach to measurement, which ensures that manufacturers adhere to consistent quality standards. By specifying clear guidelines for assessing the maximum width of insertion portions, this standard fosters interoperability among various endoscopic devices, thus aiding healthcare professionals in selecting the appropriate tools for patient care. Additionally, the relevance of ISO 8600-4:2023 cannot be overstated in the context of advancing medical technology. As endoscopic procedures become increasingly intricate, the importance of precise measurements is paramount. This standard not only contributes to the safety and efficacy of endoscopic interventions but also supports innovation in the design and production of endoscopic accessories. Moreover, by detailing the measurement process, ISO 8600-4:2023 empowers manufacturers to achieve higher levels of accuracy and reliability in their products, ultimately benefiting end-users. The adoption of this standard can lead to improved patient outcomes through the enhanced performance of medical endoscopes. In summary, ISO 8600-4:2023 represents a crucial standard in the domain of medical endoscopes, elucidating the method for determining the maximum width of insertion portions. Its comprehensive guidelines and emphasis on consistent measurement not only bolster the quality of endoscopic instruments but also significantly contribute to the ongoing advancements in medical technology.
Die ISO 8600-4:2023 legt einen wichtigen Standard für die Messung der maximalen Breite der Insertionsöffnung von medizinischen Endoskopen und bestimmten endoskopischen Zubehörteilen fest. Der Umfang dieses Dokuments ist klar umrissen und bietet einen präzisen Leitfaden zur Bestimmung dieser Maße, welche für die Sicherheit und Effizienz in der Endoskopie von zentraler Bedeutung sind. Ein wesentlicher Stärke der ISO 8600-4:2023 ist die methodische Herangehensweise an die Messung. Durch die Bereitstellung eines standardisierten Verfahrens ermöglicht die Norm, dass Hersteller und Anwender eine konsistente und vergleichbare Bewertung der Endoskope vornehmen können. Diese Konsistenz ist entscheidend, um sicherzustellen, dass alle Produkte den erforderlichen Sicherheitsstandards entsprechen und effektiv in klinischen Anwendungen eingesetzt werden können. Darüber hinaus fördert die ISO 8600-4:2023 nicht nur die Standardisierung innerhalb der Branche, sondern auch die Integration und den Austausch zwischen verschiedenen Herstellern und Gesundheitseinrichtungen. Eine klare Definition der maximalen Insertionsbreite trägt dazu bei, Komplikationen während endoskopischer Verfahren zu minimieren und die Patientensicherheit zu erhöhen. Insgesamt ist die ISO 8600-4:2023 von hoher Relevanz für die medizinische Gemeinschaft, da sie die Qualität und Sicherheit von medizinischen Endoskopen und endoskopischen Zubehörteilen unterstützt. Die Einführung und Anwendung dieses Standards wird die alltägliche Praxis in der Endoskopie verbessern und dazu beitragen, höhere Standards in der Patientenversorgung zu erreichen.
ISO 8600-4:2023は、医療内視鏡および内視鏡治療機器の最大挿入部幅を測定する方法を規定している重要な文書です。この標準は、臨床現場における内視鏡の使用において、精確な測定と適切な規格の確立を目的としています。 まず、この標準の範囲は非常に明確です。医療内視鏡と特定の内視鏡アクセサリーに焦点を当て、最大挿入部幅を測定するための手法を定義しています。このような規格は、内視鏡製品の設計や製造において一貫性と安全性を促進し、医療従事者が安心して使用できる製品の提供に寄与します。 ISO 8600-4:2023の強みは、その詳細な測定方法が業界全体での標準化を支援し、異なるメーカー間での比較を容易にする点にあります。これにより、院内の内視鏡診療における効率性や安全性が向上し、患者のケアに対する信頼性も高まります。また、この標準は、将来的な内視鏡の技術革新にも対応できる柔軟性を持っており、新たな製品開発においても有用です。 さらに、ISO 8600-4:2023は、国際的な医療機器規制に準拠しており、グローバルな市場においても通用する基準となることから、特に国際的なビジネスを展開する企業にとって大変重要なドキュメントとなります。この標準は、医療機器の安全性と効果を確保するための重要な要素を豊かに含んでおり、医療現場での使用における関連性も非常に高いです。 以上の点から、ISO 8600-4:2023は、医療内視鏡および関連機器における最大挿入部幅の測定に関して、必要不可欠であるだけでなく、医療の質を向上させるための一助となる重要な標準であると言えるでしょう。
ISO 8600-4:2023 표준은 의료 내시경 및 내시경 치료 장치의 삽입 부분 최대 너비를 측정하는 방법을 명확하게 규정하고 있습니다. 이 문서는 내시경의 안전성과 효과성을 보장하기 위한 중요한 기준을 제공하며, 의료 기기 개발자와 제조업체에게 필수적인 도구로 작용합니다. 이 표준의 강점은 측정 방법의 명확성과 일관성에 있습니다. 의료 내시경 및 관련 액세서리의 다양한 형태와 크기를 고려하면서도, ISO 8600-4:2023은 필요한 데이터의 신뢰성을 유지합니다. 이를 통해 의료 환경에서의 안전성을 높이고 환자 치료의 질을 향상시키는 데 기여할 수 있습니다. 또한, ISO 8600-4:2023 표준은 글로벌 차원에서 의료 기기의 표준화를 촉진하여, 서로 다른 국가와 지역 간의 기술적 장벽을 줄이는데 중요한 역할을 합니다. 이 같은 국제적인 접근 방식은 의료 기술의 발전을 뒷받침하며, 신뢰할 수 있는 의료 서비스를 제공하는 데 필수적입니다. 따라서, ISO 8600-4:2023은 의료 내시경 및 내시경 치료 장치의 설계와 생산에 있어 필수적인 기준을 제시하며, 업계 종사자들이 이 표준을 채택함으로써 더욱 안전하고 효과적인 의료 서비스를 제공할 수 있도록 돕는 매우 중요한 문서입니다.
La norme ISO 8600-4:2023 est d'une grande importance dans le domaine de l'endoscopie médicale. Elle précise les méthodes de mesure de la largeur maximum de la partie d'insertion des endoscopes médicaux et de certains accessoires endoscopiques. Cette standardisation est essentielle pour garantir la sécurité et l'efficacité des dispositifs utilisés dans diverses procédures médicales. L'un des principaux atouts de cette norme réside dans son approche systématique et précise pour déterminer la largeur de la partie d'insertion, permettant ainsi une meilleure évaluation des caractéristiques techniques des endoscopes. En assurant une uniformité dans les méthodes de mesure, la norme favorise la comparabilité entre différents produits et fabricants, contribuant ainsi à l'amélioration continue de la qualité des endoscopes médicaux. La portée de la norme ISO 8600-4:2023 est également très pertinente dans le contexte actuel, où l'utilisation des endoscopes et des dispositifs d'endothérapie est en constante augmentation. En normalisant les spécifications techniques, cette norme aide à minimiser les risques associés aux interventions médicales, garantissant que les professionnels de la santé disposent d'informations fiables pour choisir les instruments adaptés à leurs besoins. En conclusion, la norme ISO 8600-4:2023 représente une avancée significative dans la standardisation des endoscopes médicaux et des dispositifs d'endothérapie, offrant des avantages notables en termes de sécurité, de qualité et de performance.
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