EN ISO 10555-3:2013
(Main)Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013)
Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013)
ISO 10555-3:2013 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use.
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 3: Zentrale venöse Katheter (ISO 10555-3:2013)
Dieser Teil der ISO 10555 legt Anforderungen an zentrale Venenkatheter fest, die steril geliefert werden und zur einmaligen Verwendung bestimmt sind.
ANMERKUNG Zu beachten ist ISO 11070, die Anforderungen an Zubehörteile zum Gebrauch mit intravaskulären Kathetern festlegt.
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 3: Cathéters centraux veineux (ISO 10555-3:2013)
L'ISO 10555-3:2013 spécifie les exigences relatives aux cathéters centraux veineux fournis dans des conditions stériles, non réutilisables.
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 3. del: Osrednji venski katetri (ISO 10555-3:2013)
Ta del standarda ISO 10555 določa zahteve za osrednje venske katetre, dobavljene v sterilnem stanju in namenjene za enkratno uporabo.
General Information
- Status
- Published
- Publication Date
- 09-Jul-2013
- Withdrawal Date
- 30-Jan-2014
- Technical Committee
- CEN/TC 205 - Non-active medical devices
- Drafting Committee
- CEN/TC 205 - Non-active medical devices
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 10-Jul-2013
- Completion Date
- 10-Jul-2013
Relations
- Effective Date
- 17-Jul-2013
- Effective Date
- 18-Sep-2010
Overview
EN ISO 10555-3:2013 is an international standard specifying the requirements for sterile, single-use central venous catheters. Developed by ISO/TC 84 and coordinated with CEN, this standard ensures that central venous catheters (CVCs) meet strict safety, performance, and usability criteria, supporting healthcare providers in delivering safe intravascular access.
Central venous catheters are essential medical devices designed for vascular access in various clinical settings, including administration of medications, fluids, blood sampling, and hemodynamic monitoring. This standard applies specifically to CVCs supplied in sterile condition for single use only, underlining the importance of maintaining sterility and preventing cross-contamination.
Key Topics
1. Scope and Definitions
- Specifies requirements for central venous catheters intended for the central venous system.
- Covers single- or multi-lumen catheters, which may incorporate a fixation system.
- Emphasizes single-use, sterile catheters to minimize infection risks.
2. Design and Markings
- Distance Markings: If present, these markings must indicate distance from the catheter's distal end, with intervals not exceeding 5 cm. Recommended marking intervals of 1 cm assist in accurate placement and monitoring of catheter migration.
- Lumen Identification: Multi-lumen catheters must clearly identify each lumen, facilitating safe and precise usage.
3. Performance Requirements
- Peak Tensile Force: Specifies minimum tensile force for catheter tips, especially those made from softer materials or constructed differently from the shaft, ensuring mechanical stability and preventing tip detachment during use.
- Compliance with performance parameters outlined in ISO 10555-1 except for specific tensile force requirements unique to this part.
4. Manufacturer Information
- Manufacturers must provide detailed product information including:
- Description of distance marking system (if applicable)
- Flow rate for each lumen to inform clinical usage
- Maximum guidewire diameter compatible with the catheter
- Warnings against unsafe catheter manipulations (e.g., withdrawing catheter back through the needle)
- Recommended cleaning agents, even though catheters are intended for single use, supporting best practice for device handling.
Applications
EN ISO 10555-3:2013 central venous catheters are critical in various clinical procedures such as:
- Administration of intravenous therapies including chemotherapy, antibiotics, and parenteral nutrition.
- Central venous pressure monitoring and hemodynamic assessment.
- Long-term vascular access for critically ill patients or those requiring frequent blood sampling.
- Emergency interventions and dialysis access.
Adherence to this standard ensures these catheters provide reliable performance while minimizing risks such as infection, thrombosis, and mechanical failure – paramount in intensive care units, oncology wards, and surgical settings.
Related Standards
This part of ISO 10555 is part of a broader series addressing sterile and single-use intravascular catheters:
- ISO 10555-1:2013: General requirements for sterile and single-use intravascular catheters.
- ISO 10555-4: Balloon dilatation catheters.
- ISO 10555-5: Over-needle peripheral catheters.
- Upcoming parts include subcutaneous implanted ports.
Additionally, ISO 11070 specifies requirements for accessory devices compatible with intravascular catheters.
Summary
EN ISO 10555-3:2013 standardizes the design, performance, and user information for sterile, single-use central venous catheters, enhancing patient safety and clinical efficacy. It supports compliance with EU directives governing medical devices, fostering harmonized quality and regulatory alignment across member states. Healthcare providers and manufacturers benefit from its comprehensive guidance to optimize central venous catheter use in diverse medical interventions.
Keywords: EN ISO 10555-3:2013, central venous catheters, sterile catheters, single-use intravascular catheters, catheter standards, catheter markings, catheter tensile strength, intravascular device safety, catheter manufacturing requirements, medical device standards, ISO standards for catheters.
Frequently Asked Questions
EN ISO 10555-3:2013 is a standard published by the European Committee for Standardization (CEN). Its full title is "Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013)". This standard covers: ISO 10555-3:2013 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use.
ISO 10555-3:2013 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use.
EN ISO 10555-3:2013 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment; 11.040.25 - Syringes, needles an catheters. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 10555-3:2013 has the following relationships with other standards: It is inter standard links to EN ISO 10555-3:1997/AC:2002, EN ISO 10555-3:1997. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 10555-3:2013 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 10555-3:2013 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.
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2013
1DGRPHãþD
SIST EN ISO 10555-3:2000
SIST EN ISO 10555-3:2000/AC:2002
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 3. del: Osrednji venski
katetri (ISO 10555-3:2013)
Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous
catheters (ISO 10555-3:2013)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 3: Zentrale
venöse Katheter (ISO 10555-3:2013)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 3: Cathéters
veineux centraux (ISO 10555-3:2013)
Ta slovenski standard je istoveten z: EN ISO 10555-3:2013
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 10555-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2013
ICS 11.040.25 Supersedes EN ISO 10555-3:1997
English Version
Intravascular catheters - Sterile and single-use catheters - Part
3: Central venous catheters (ISO 10555-3:2013)
Cathéters intravasculaires - Cathéters stériles et non Intravaskuläre Katheter - Sterile Katheter zur einmaligen
réutilisables - Partie 3: Cathéters centraux veineux (ISO Verwendung - Teil 3: Zentrale venöse Katheter (ISO 10555-
10555-3:2013) 3:2013)
This European Standard was approved by CEN on 29 May 2013.
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 CEN-CENELEC 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 CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-3:2013: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 10555-3:2013) has been prepared by Technical Committee ISO/TC 84 “Devices for
administration of medicinal products and intravascular catheters” in collaboration with Technical Committee
CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
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 January 2014, and conflicting national standards shall be withdrawn at
the latest by January 2014.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10555-3:1997.
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 Annex ZA, which is an integral part of this document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10555-3:2013 has been approved by CEN as EN ISO 10555-3:2013 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC amended by Directive
2007/47/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association to provide a means of conforming to Essential Requirements of Directive 93/42/EEC
amended by Directive 2007/47/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented
as a national standard in at least one Member State, compliance with the normative clauses of this standard given in
Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the relevant Essential
Requirements of that Directive.
NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1— Correspondence between this European Standard and Directive 93/42/EEC amended by
Directive 2007/47/EEC
Essential Requirements (ERs) of Directive Clause(s)/sub-clause(s) of this
93/42/EEC EN ISO 10555-3
7.3 4.1
7.5 4.1
8.1 4.1
8.3 4.1
8.4 4.1
9.1 4.1
9.2 4.1
4.2
4.3
4.4
12.7.1 4.1
4.4
12.7.4 4.1
12.8.1 4.1
12.9 4.2*
4.3*
13.1 4.1
13.2 4.1
13.3 a) 4.1
13.3 b) 4.1
13.3 c) 4.1
13.3 d) 4.1
13.3 e) 4.1
13.3 f) 4.1
13.3 i) 4.1
13.3 j) 4.1
13.3 k) 4.1
4.5 d)
13.3 m) 4.1
13.4 4.1
13.6 a) 4.1
13.6 b) 4.1
4.5 a), b) and c)
13.6 c) 4.1
13.6 e) 4.1
13.6 f) 4.1
13.6 g) 4.1
13.6 h 4.5 c)**
13.6 k) 4.1
13.6 l) 4.1
13.6 n) 4.1
13.6 q) 4.1
(*) Not applicable for the patient.
(**) The information is on cleaning even though it is not a reusable devices.
WARNING — Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.
INTERNATIONAL ISO
STANDARD 10555-3
Second edition
2013-06-15
Intravascular catheters — Sterile and
single-use catheters —
Part 3:
Central venous catheters
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 3: Cathéters centraux veineux
Reference number
ISO 10555-3:2013(E)
©
ISO 2013
ISO 10555-3:2013(E)
© ISO 2013
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SIST EN ISO 10555-3:2013 は、中心静脈カテーテルに関する規格として、医療現場における重要な役割を果たします。この標準では、無菌状態で供給される一回使用の中心静脈カテーテルの要件が明確に定義されています。中心静脈カテーテルは患者の治療において非常に重要であり、この規格はその安全性と効果を確保するための基盤を提供しています。 この規格の強みは、無菌性と一回使用という要件が厳格に定められていることです。これにより、医療現場での感染リスクを大幅に低減させることが可能となり、患者安全を第一に考えた設計がなされています。また、国際的な標準として、エビデンスに基づいた医療の実現に寄与しており、各国の医療機関での導入が進んでいます。 さらに、EN ISO 10555-3:2013 は、中心静脈カテーテルの設計と製造における品質管理の重要性を強調しています。規格は、製品の性能を保証するための試験方法や品質基準を含んでおり、医療機器の信頼性を高めることに寄与しています。このようにして、本標準は医療技術の発展と、患者への適切な治療提供のための支援を行っています。 全体として、SIST EN ISO 10555-3:2013 は、中心静脈カテーテルの標準化において画期的な役割を果たしており、無菌かつ一回使用という要件を通じて、医療の質を向上させるための貴重な基盤を提供しています。その適用は、患者と医療従事者の双方に利益をもたらすものとなっています。
The standard EN ISO 10555-3:2013 provides a comprehensive framework for the design, testing, and quality assessment of central venous catheters. The scope of this standard specifies the essential requirements to ensure that these intravascular catheters are safe, effective, and used appropriately in a clinical setting. By highlighting the requirement for sterility and single-use design, the standard addresses crucial aspects of infection control, which is vital for patient safety in medical practices. One of the strengths of ISO 10555-3:2013 is its emphasis on rigorous quality management processes and testing protocols that manufacturers must adhere to. This contributes to the reliability and efficacy of central venous catheters, ensuring that healthcare professionals can confidently use these devices in various medical situations. The specific criteria laid out for materials, manufacturing processes, and performance testing are designed to help minimize risks associated with catheter use, such as infection and thrombus formation. The relevance of this standard is underscored by the growing demand for safe and effective medical devices in the healthcare industry. As central venous catheters are widely utilized for administration of medications, fluids, and for hemodynamic monitoring, the guidelines established by EN ISO 10555-3:2013 play a crucial role in enhancing patient outcomes. This standard ensures that all products meet internationally recognized benchmarks, which supports global trade, harmonizes practices, and fosters innovation in intravascular technology. By adhering to the stipulations of ISO 10555-3:2013, manufacturers contribute to a standard of quality that not only adheres to regulatory requirements but also reflects best practices in healthcare. The clear definitions and detailed specifications within the standard make it an indispensable document for both manufacturers and healthcare providers aiming to maintain high standards in the use and application of central venous catheters.
La norme EN ISO 10555-3:2013, intitulée "Cathéters intravasculaires - Cathéters stériles et à usage unique - Partie 3 : Cathéters veineux centraux", définit des exigences claires et précises pour les cathéters veineux centraux fournis dans un état stérile et destinés à un usage unique. Cette norme est particulièrement pertinente dans le domaine médical, où la sécurité et la stérilité des dispositifs intravasculaires sont primordiales. L'un des points forts de cette norme réside dans son approche systématique de la sécurité des patients. En définissant des critères stricts pour la conception, la fabrication et l'évaluation des cathéters veineux centraux, la norme contribue à minimiser les risques d'infections et à garantir des performances fiables. La standardisation des processus de fabrication permet également d'harmoniser la qualité des produits sur le marché, ce qui est essentiel pour les professionnels de la santé. En outre, la norme EN ISO 10555-3:2013 est d'une grande pertinence en raison de l'augmentation continue de l'utilisation des cathéters veineux centraux dans diverses procédures médicales. Sa mise en œuvre peut améliorer la confiance des utilisateurs et des patients, favorisant ainsi des résultats cliniques positifs. Par ailleurs, cette norme facilite la conformité réglementaire, non seulement pour les fabricants, mais aussi pour les établissements de santé qui utilisent ces dispositifs. La clarté des exigences définies par la norme aide également à la formation des professionnels de la santé, garantissant qu'ils comprennent bien les protocoles nécessaires pour l'utilisation sécurisée des cathéters veineux centraux. En somme, EN ISO 10555-3:2013 s'impose comme une référence incontournable pour la normalisation des cathéters veineux centraux, intégrant des aspects cruciaux de sécurité et d'efficacité dans l'environnement médical moderne.
EN ISO 10555-3:2013 표준은 중앙정맥 카테터에 대한 규정을 명확히 하고 있으며, 특히 멸균 상태에서 공급되는 일회용 카테터의 요구사항을 설정하고 있습니다. 이 표준의 주요 강점은 안전성과 효율성을 동시에 보장하는 데 있습니다. 카테터의 설계 및 제조 과정에서 반드시 준수해야 할 기준을 명시함으로써, 의료진과 환자에게 발생할 수 있는 감염 위험을 최소화하는 데 중점을 두고 있습니다. 표준의 적용 범위는 중앙정맥 카테터의 안전한 사용을 보장하는 데 필요한 모든 측면을 아우릅니다. 이는 사용자의 편의성을 고려한 디자인뿐 아니라, 다양한 임상 환경에서 사용될 수 있도록 다양한 크기와 타입의 카테터를 포함하여 더욱 폭넓은 적용이 가능합니다. 표준화 문서인 SIST EN ISO 10555-3:2013은 이러한 요구사항을 구체적으로 서술함으로써, 관련 업계의 품질 관리를 세분화하고 일관성 있게 유지할 수 있게 합니다. 또한, EN ISO 10555-3:2013 표준은 글로벌하게 통용되는 기준으로, 국제적인 거래 및 협력을 촉진하는 데 기여합니다. 이는 전 세계적으로 의료 기기 제조사가 동일한 기준을 준수하게 하여, 제품의 신뢰성과 시장 접근성을 확보하도록 돕습니다. 이러한 점에서 이 표준은 보건의료 분야에서 매우 중요한 역할을 하고 있으며, 최신의 의료 요구를 반영하고 있다고 할 수 있습니다.
Die Norm EN ISO 10555-3:2013 legt spezifische Anforderungen für zentrale venöse Katheter fest, die in steriler Form geliefert und für den einmaligen Gebrauch bestimmt sind. Sie spielt eine entscheidende Rolle im Gesundheitswesen, insbesondere in der Intensivmedizin und der Anästhesiologie, wo der Einsatz von zentralen venösen Kathetern essentiell ist. Eine der größten Stärken der Norm ist die klare Definition der Anforderungen an die Sterilität und Sicherheit der Katheter. Dies stellt sicher, dass die eingesetzten Produkte höchste Hygienestandards erfüllen, was unmittelbar zur Vermeidung nosokomialer Infektionen beiträgt. Des Weiteren wird durch die Spezifikation von Anforderungen zur biokompatiblen Materialauswahl die Verträglichkeit der Katheter mit menschlichem Gewebe gewährleistet. Ein weiterer relevanter Aspekt dieser Norm ist die Fokussierung auf die Eignung für den einmaligen Gebrauch. Dies reduziert das Risiko von Kreuzkontaminationen und unterstützt die aktuelle Tendenz in der medizinischen Praxis, Instrumente zu nutzen, die nur einmal verwendet werden, um die Patientensicherheit zu maximieren. Die Norm ist außerdem von großer Relevanz für Hersteller von medizinischen Produkten, da sie klare Leitlinien für die Entwicklung und Produktion zentraler venöser Katheter bietet. Die Einhaltung dieser Norm kann nicht nur zur Verbesserung der Produktqualität beitragen, sondern auch das Vertrauen der Gesundheitsdienstleister und Patienten in die Sicherheit der verwendeten Produkte stärken. Insgesamt stellt die EN ISO 10555-3:2013 eine essentielle Grundlage für die Herstellung, Verwendung und Bewertung zentraler venöser Katheter dar und trägt erheblich zur Normierung und Verbesserung der medizinischen Praktiken im Bereich der intravenösen Therapie bei.
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