SIST EN ISO 20695:2020

Enteral feeding systems - Design and testing (ISO 20695:2020)

This European Standard specifies requirements for the design and testing of single-use enteral feeding catheters, single-use enteral giving sets and their connection systems.
Requirements for radiodetectable enteral feeding catheters are not given in this standard.

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

• Status: Published
• Public Enquiry End Date: 04-Oct-2017
• Publication Date: 17-May-2020
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 16-Apr-2020
• Due Date: 21-Jun-2020
• Completion Date: 18-May-2020
• 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 20695:2020 - Enteral feeding systems - Design and testing (ISO 20695:2020)

Relations

• Replaces: SIST EN 1618:2000 - Catheters other than intravascular catheters - Test methods for common properties
• Effective Date: 01-Jun-2020
• Replaces: SIST EN 1615:2001 - Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing
• Effective Date: 01-Jun-2020

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 20695:2020
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
SIST EN ISO 20695:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 20695:2020
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SIST EN ISO 20695:2020
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.
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SIST EN ISO 20695:2020
EN ISO 20695:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 20695:2020
EN ISO 20695:2020 (E)
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.

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SIST EN ISO 20695:2020
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SIST EN ISO 20695:2020
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
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SIST EN ISO 20695:2020
ISO 20695:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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 the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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SIST EN ISO 20695:2020
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 volume ................................................................................................................................................12

7.7.2 Balloon recommended inflation volume ..................................................................................................12

7.7.3 Balloon inflation system performance .......................................................................................................12

7.7.4 Balloon concentricity ................................................................................................................................................13

7.7.5 Balloon integrity in simulated gastric fluid ...........................................................................................13

© ISO 2020 – All rights reserved iii
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SIST EN ISO 20695:2020
ISO 20695:2020(E)

7.8 Detectability ...........................................................................................................................................................................................13

7.8.1 General...................................................................................................................................................................................13

7.8.2 Catheters designed to be radiopaque .........................................................................................................13

7.8.3 MRI compatibility.........................................................................................................................................................13

7.9 Marking ......................................................................................................................................................................................................13

8 Additional requirements for enteral accessories ...........................................................................................................13

Annex A (informative) Rationale and guidance .....................................................................................................................................15

Annex B (normative) Test method for corrosion resistance of metallic components ...................................18

Annex C (normative) Test method for tensile properties ............................................................................................................20

Annex D (normative) Test method for resistance to liquid leakage under pressure......................................22

Annex E (normative) Test method for determining the flow rate .......................................................................................24

Annex F (normative) Test method for determining the designated outer diameter of enteral

feeding catheters ...............................................................................................................................................................................................27

Annex G (normative) Test method for determining balloon burst volume ..............................................................30

Annex H (normative) Test method for determining balloon inflation system performance ..................32

Annex I (normative) Test method for determining balloon concentricity ................................................................34

Annex J (normative) Test method for determining balloon integrity in simulated gastric fluid .......36

Annex K (informative) Example of an alternative enteral syringe tip ............................................................................38

Bibliography .............................................................................................................................................................................................................................42

iv © ISO 2020 – All rights reserved
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SIST EN ISO 20695:2020
ISO 20695:2020(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/

iso/ foreword .html.

This document was prepared by the European Committee for Standardization (CEN) Technical

Committee CEN/TC 205, Non-active medical devices, in collaboration with ISO Technical Committee

TC 84, Devices for administration of medicinal products and catheters, in accordance with the Agreement

on technical cooperation between ISO and CEN (Vienna Agreement).

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2020 – All rights reserved v
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SIST EN ISO 20695:2020
ISO 20695:2020(E)
Introduction

Enteral feeding systems are intended to facilitate the delivery of enteral nutrition, medications and

hydration to, or aspiration of gastric content from, humans. They are designed to pass enteral fluids

or substances through the nose or mouth, or by gastrostomy, jejunostomy or oesophagostomy. Enteral

feeding catheters are terminally placed in the stomach, duodenum, or jejunum.

The requirements and test methods of this document are specified so that, when used in current clinical

practice, these medical devices do not compromise the clinical condition or the safety of patients.

Incidents have been reported of enteral fluids or substances being administered via incorrect routes,

including intravenously and into the airway. An international effort has been made to reduce these

incidents and two series of International Standards have been developed to provide application specific

connectors:

— ISO 80369-3 specifies connectors intended for use between an enteral giving set, enteral extension

sets, enteral syringes, enteral catheters, and enteral accessories;

— ISO 18250-3 specifies connectors intended for use between an enteral giving set, an enteral

accessory and an enteral reservoir.

The use of these enteral-specific connectors has been specified in this document as well as small-bore

connectors as specified in ISO 80369-1:2018, Clause 6.

ISO 80369-3 and ISO 18250-3 ensure that connectors for enteral giving sets, enteral extension sets,

enteral syringes, enteral feeding catheters and enteral accessories are unique and are not able to

be connected to other small-bore connectors specified in the ISO 80369 series for the following

applications: intravascular and hypodermic, breathing systems and driving gases, urethral and urinary,

limb cuff inflation and neuraxial systems.

The small-bore connectors and reservoir connectors, as defined in ISO 80369-3 and ISO 18250-3,

respectively, for use in enteral applications should not, but may connect with the following connectors/

ports in common use within the same environment:
— the cones and sockets of ISO 5356-1 and ISO 5356-2;

— the temperature sensor ports made in conformity with ISO 80601-2-74:2017, Annex EE;

— the nipples of EN 13544-2 and EN 13544-2+A1.

In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true, if any

combination of the conditions is true.
The verbal forms used in this document are as follows:

— “shall” means conformity with a requirement or a test is mandatory for conformity with this

document,

— “should” means conformity with a requirement or a test is recommended but is not mandatory for

conformity with this document, and

— “may” is used to describe a permissible way to achieve conformity with a requirement or test.

vi © ISO 2020 – All rights reserved
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SIST EN ISO 20695:2020
INTERNATIONAL STANDARD ISO 20695:2020(E)
Enteral feeding systems — Design and testing
1 Scope

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.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 7000, Graphical symbols for use on equipment — Registered symbols

ISO 7886-1:2017, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use

ISO 7886-2:1996, Sterile hypodermic syringes for single use — Part 2: Syringes for use with power-driven

syringe pumps

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process

ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,

validation and routine control of a sterilization process for medical devices

ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,

validation and routine control of a sterilization process for medical devices

ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,

sterile barrier systems and packaging systems

ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for

forming, sealing and assembly process

ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing

agent and the development, validation and routine control of a sterilization process for medical devices

ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to

be supplied — Part 1: General requirements

ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,

validation and routine control of a sterilization process for medical devices

ISO 18250-3:2018, Medical devices — Connectors for reservoir delivery systems for healthcare

applications — Part 3: Enteral applications

ISO 25424, Sterilization of health care products — Low temperature steam and formaldehyde —

Requirements for development, validation and routine control of a sterilization process for medical devices

ISO 80369-1, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General

requirements

ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors

for enteral applications
© ISO 2020 – All rights reserved 1
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SIST EN ISO 20695:2020
ISO 20695:2020(E)
ASTM F640, Standard Test Methods for Determining Radiopacity for Medical Use

DIN 13273-7, Catheter for medical use — Part 7: Determination of the x-ray attenuation of catheters;

requirements and testing
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
distal end

end of the medical device furthest from the source of the nutrient or diet intended to be administered

via an enteral feeding catheter (3.5)
Note 1 to entry: See Figure 1.
3.2
proximal end

end of the medical device closest to the source of nutrient or diet intended to be administered via an

enteral feeding catheter (3.5)
Note 1 to entry: See Figure 1.
3.3
enteral feeding system

system comprising the following enteral feeding devices: enteral giving sets (3.6), enteral syringes (3.8),

enteral feeding catheters (3.5), and enteral accessories (3.4)
3.4
enteral accessory

medical device that is used within the enteral system for the purposes of device placement or access

of an enteral device; or for the purposes of filling, directing, stopping, or controlling flow of nutrients,

medication, or aspirates
EXAMPLE Sheaths, guidewires, introducers.
3.5
enteral feeding catheter

indwelling tubular medical device to facilitate delivery or removal of fluids or substances into or from

the gastrointestinal tract
3.6
enteral giving set

medical device for transferring enteral fluids or substances from an enteral reservoir to an enteral

feeding catheter (3.5)
Note 1 to entry: Also known as enteral feeding sets.
Note 2 to entry: See Figure 1 for an example.
3.7
enteral extension set

medical device for transferring enteral fluids or substances from an enteral giving set (3.6) to an enteral

feeding catheter (3.5)
Note 1 to entry: Also known as extension tubing.
2 © ISO 2020 – All rights reserved
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SIST EN ISO 20695:2020
ISO 20695:2020(E)
Note 2 to entry: See Figure 1 for an example.
3.8
enteral syringe

medical device for introduction or removal of fluids or substances into or from the gastrointestinal

tract by means of pressure

Note 1 to entry: This does not include syringes for introducing fluids or substances directly into the mouth, i.e.

...