SIST EN ISO 10555-6:2017/A1:2019
(Amendment)Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports - Amendment 1 (ISO 10555-6:2015/Amd 1:2019)
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports - Amendment 1 (ISO 10555-6:2015/Amd 1:2019)
ISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.
ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring needles.
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung — Teil 6: Subkutan implantierte Ports - Änderung 1 (ISO 10555-6:2015/Amd 1:2019)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 6: Chambres à cathéter implantables - Amendement 1 (ISO 10555-6:2015/Amd 1:2019)
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 6. del: Podkožni vsadki - Dopolnilo A1 (ISO 10555-6:2015/Amd 1:2019)
Standard ISO 10555-6:2015 opredeljuje zahteve, učinkovitost in varnostna vprašanja, povezana s podkožnimi vsadki in katetri za intravaskularno dolgoročno uporabo, ki so dobavljeni sterilni in so namenjeni za enkratno uporabo.
Standard 10555-6:2015 ne določa zahtev, zmogljivosti in varnostnih vprašanj, povezanih z iglami, ki preprečujejo puščanje.
General Information
- Status
- Published
- Public Enquiry End Date
- 19-Jul-2019
- Publication Date
- 17-Nov-2019
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 04-Nov-2019
- Due Date
- 09-Jan-2020
- Completion Date
- 18-Nov-2019
Relations
- Effective Date
- 01-Dec-2019
Overview
EN ISO 10555-6:2017/A1:2019 is Amendment 1 to the international standard ISO 10555-6 (Part 6) covering subcutaneous implanted ports - a class of sterile, single‑use intravascular catheters. Endorsed by CEN and published in October 2019, this amendment updates specific performance requirements for flow-rate verification and clarifies test conditions for certain catheter types.
Key topics and technical requirements
- Scope: Applies to sterile, single‑use intravascular catheters in the form of subcutaneous implanted ports (EN ISO 10555-6).
- Flow‑rate acceptance criteria (clause 4.6 amended):
- For devices where a flow rate is defined, testing shall follow:
- ISO 10555-1:2013, Annex E (all ports), and
- ISO 10555-1:2013, Annex G (ports indicated for power injection).
- Minimum flow rates per lumen:
- ≥ 80% of the flow stated in the Instructions for Use (IFU) for catheters with nominal outside diameter (OD) less than 1.0 mm.
- ≥ 90% of the flow stated in the IFU for catheters with nominal OD equal to or greater than 1.0 mm.
- For devices where a flow rate is defined, testing shall follow:
- Hydratable catheters: If flow is measured for hydratable materials, the flow rate must be determined in the post‑hydration state (i.e., after the catheter has been hydrated according to its intended use).
- Standards adoption: The amendment is an ISO update adopted as a European standard (EN ISO) and is to be implemented by CEN member bodies.
Practical applications and who uses it
This amendment is relevant to stakeholders involved in the design, manufacture, testing, procurement and clinical use of implanted vascular access ports:
- Medical device manufacturers - for product design validation, IFU claims, bench testing and regulatory compliance.
- Independent test laboratories - to perform flow performance testing in accordance with ISO 10555-1 Annexes E and G and to report results against the 80/90% acceptance criteria.
- Regulatory and quality teams - to demonstrate conformity with internationally harmonized performance requirements for submission and certification.
- Hospital procurement and clinical engineers - to evaluate device performance claims (e.g., suitability for power injection).
- Clinicians and interventional radiologists - beneficial for understanding performance limits and safe use for infusion and power injection procedures.
Related standards
- ISO 10555-1:2013 - General test methods and requirements referenced for flow testing (Annex E and Annex G).
- Other parts of the ISO 10555 series - provide complementary requirements for different catheter types and test methods.
Keywords: EN ISO 10555-6:2017/A1:2019, ISO 10555-6, subcutaneous implanted ports, intravascular catheters, sterile single-use catheters, flow rate, power injection, hydratable catheters, medical device standards, catheter testing.
Frequently Asked Questions
SIST EN ISO 10555-6:2017/A1:2019 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports - Amendment 1 (ISO 10555-6:2015/Amd 1:2019)". This standard covers: ISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use. ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring needles.
ISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use. ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring needles.
SIST EN ISO 10555-6:2017/A1:2019 is classified under the following ICS (International Classification for Standards) categories: 11.040.25 - Syringes, needles an catheters. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 10555-6:2017/A1:2019 has the following relationships with other standards: It is inter standard links to SIST EN ISO 10555-6:2017. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 10555-6:2017/A1:2019 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2019
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 6. del: Podkožni vsadki -
Dopolnilo A1 (ISO 10555-6:2015/Amd 1:2019)
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous
implanted ports - Amendment 1 (ISO 10555-6:2015/Amd 1:2019)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung — Teil 6:
Subkutan implantierte Ports - Änderung 1 (ISO 10555-6:2015/Amd 1:2019)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 6: Chambres à
cathéter implantables - Amendement 1 (ISO 10555-6:2015/Amd 1:2019)
Ta slovenski standard je istoveten z: EN ISO 10555-6:2017/A1:2019
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.
EN ISO 10555-6:2017/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 11.040.25
English Version
Intravascular catheters - Sterile and single-use catheters -
Part 6: Subcutaneous implanted ports - Amendment 1 (ISO
10555-6:2015/Amd 1:2019)
Cathéters intravasculaires - Cathéters stériles et non Intravaskuläre Katheter - Sterile Katheter zur
réutilisables - Partie 6: Chambres à cathéter einmaligen Verwendung - Teil 6: Subkutan
implantables - Amendement 1 (ISO 10555- implantierte Ports - Änderung 1 (ISO 10555-
6:2015/Amd 1:2019) 6:2015/Amd 1:2019)
This amendment A1 modifies the European Standard EN ISO 10555-6:2017; it was approved by CEN on 6 September 2019.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-6:2017/A1:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 10555-6:2017/A1:2019) has been prepared by Technical Committee ISO/TC 84
"Devices for administration of medicinal products and catheters" in collaboration with Technical
Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
This Amendment to the European Standard EN ISO 10555-6:2017 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by April 2020, and
conflicting national standards shall be withdrawn at the latest by April 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorseme
...
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