SIST EN ISO 20695:2020
(Main)Enteral feeding systems - Design and testing (ISO 20695:2020)
Enteral feeding systems - Design and testing (ISO 20695:2020)
This document specifies requirements for enteral feeding systems comprising enteral giving sets, enteral extension sets, enteral syringes, enteral feeding catheters, and enteral accessories.
This document is not applicable to oral syringes.
Systeme zur enteralen Ernährung - Ausführung und Prüfung (ISO 20695:2020)
Dieses Dokument legt Anforderungen an Ausführung, Sicherheit und Leistungsverhalten von Systemen zur enteralen Ernährung fest, die enterale Überleitungsgeräte, enterale Verlängerungssets, enterale Spritzen, Katheter zur enteralen Ernährung und Zubehör für enterale Anwendungen umfassen.
Dieses Dokument gilt nicht für Spritzen zur oralen Applikation.
Systèmes de nutrition entérale - Conception et essais (ISO 20695:2020)
Le présent document établit les exigences relatives aux systèmes de nutrition entérale, y compris les tubulures entérales, les prolongateurs pour nutrition entérale, les seringues entérales, les sondes de nutrition entérale et leurs accessoires.
Le présent document n'est pas applicable aux seringues orales.
Enteralni sistemi (katetri) za hranjenje - Oblikovanje in preskušanje (ISO 20695:2020)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2020
Nadomešča:
SIST EN 1615:2001
SIST EN 1618:2000
Enteralni sistemi (katetri) za hranjenje - Oblikovanje in preskušanje (ISO
20695:2020)
Enteral feeding systems - Design and testing (ISO 20695:2020)
Systeme zur enteralen Ernährung - Ausführung und Prüfung (ISO 20695:2020)
Systèmes de nutrition entérale - Conception et essais (ISO 20695:2020)
Ta slovenski standard je istoveten z: EN ISO 20695:2020
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 20695
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2020
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN 1615:2000, EN 1618:1997
English Version
Enteral feeding systems - Design and testing (ISO
20695:2020)
Systèmes de nutrition entérale - Conception et essais Systeme zur enteralen Ernährung - Ausführung und
(ISO 20695:2020) Prüfung (ISO 20695:2020)
This European Standard was approved by CEN on 29 November 2019.
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, 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20695:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 20695:2020) 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 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 October 2020, and conflicting national standards shall
be withdrawn at the latest by April 2023.
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.
This document supersedes EN 1618:1997 and EN 1615:2000.
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.
Endorsement notice
The text of ISO 20695:2020 has been approved by CEN as EN ISO 20695:2020 without any modification.
INTERNATIONAL ISO
STANDARD 20695
First edition
2020-03
Enteral feeding systems — Design
and testing
Cathéters de nutrition entérale — Conception et essais
Reference number
ISO 20695:2020(E)
©
ISO 2020
ISO 20695:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2020 – All rights reserved
ISO 20695:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 3
4.1 General . 3
4.2 Risk management . 3
4.3 Usability . 3
4.4 Test methods . 3
4.5 Materials . 3
4.6 Cleaning and disinfection . . 4
4.7 Sterility . 4
4.8 Packaging . 4
4.9 Biological safety . 4
4.10 Corrosion resistance . 4
4.11 Surface finish . 4
4.12 Information supplied by the manufacturer . 4
4.12.1 Marking . 4
4.12.2 Symbols . 5
4.12.3 Labelling . 5
4.12.4 Instructions for use. 5
5 Additional requirements for enteral giving sets and enteral extension sets .6
5.1 General . 6
5.2 Inlet ports . 6
5.3 Outlet ports . 6
5.4 Access ports . 7
5.5 Tensile strength . 7
5.6 Leakage . 7
5.7 Additional information provided by the manufacturer . 7
6 Additional requirements for enteral syringes . 9
6.1 General . 9
6.2 Outlet port . 9
6.3 Enteral syringe requirements . 9
6.4 Enteral Syringe dose accuracy requirement.10
6.5 Marking .10
7 Additional requirements for enteral feeding catheters .10
7.1 General .10
7.2 Access ports .11
7.3 Tensile properties .11
7.3.1 Enteral feeding catheters designed for use without an integral introducer
system .11
7.3.2 Enteral feeding catheters with an integral introducer system .11
7.4 Leakage properties .11
7.5 Flow rate .12
7.6 Enteral feeding catheter designated size .12
7.7 Requirements for enteral feeding catheters with retention balloons .12
7.7.1 Balloon burst
...
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