SIST EN 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 veineux centraux (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
• Public Enquiry End Date: 19-Jan-2012
• Publication Date: 08-Oct-2013
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Oct-2013
• Due Date: 06-Dec-2013
• Completion Date: 09-Oct-2013
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 10555-3:2013 - Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013)

Relations

• Replaces: SIST EN ISO 10555-3:2000/AC:2002 - Sterile, single-use intravascular catheters - Part 3: Central venous catheters (ISO 10555-3:1996/Cor.1:2002)
• Effective Date: 01-Nov-2013
• Replaces: SIST EN ISO 10555-3:2000 - Sterile, single-use intravascular catheters - Part 3: Central venous catheters (ISO 10555-3:1996)
• Effective Date: 01-Nov-2013

Overview

SIST 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

SIST 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

SIST 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.

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Keywords: SIST 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.

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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