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
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.
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
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Published in Switzerland
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 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 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
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 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
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 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
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.
oral-only syringes.
3.9
integral introducer
component that is attached to a percutaneous enteral feeding catheter (3.5) which is designed to
facilitate initial catheter placement starting from inside the gastro-intestinal tract and ending outside
the abdominal wall
4 General requirements
4.1 General
The following requirements apply to all components of the enteral feeding system unless superseded in
the specific requirements in Clauses 5, 6, 7 and 8.
4.2 Risk management
An established risk management process shall be applied to the design and development of the enteral
feeding system.
NOTE ISO 14971 provides requirements and guidance for risk management of medical devices.
Check conformity by inspection of the risk management file.
4.3 Usability
An established usability engineering process shall be applied to the design of the enteral feeding system
to assess and mitigate risks caused by usability problems associated with correct use and use errors.
NOTE IEC 62366-1 provides requirements and guidance on the application of usability of medical devices.
Check conformity by inspection of the usability-engineering file.
4.4 Test methods
The medical device shall be tested in accordance with the test methods specified in Annexes B to J.
Alternative test methods may be used if an equivalent degree of safety is obtained and the results of
those alternative test methods can be related to the results obtained using the test methods specified
in this document.
Check conformity by inspection of the technical file.
4.5 Materials
For certain materials, specific labelling and risk assessment requirements might apply, depending on
national or regional regulations.
EXAMPLE Natural rubber latex, certain plasticizers used in polyvinyl chloride (PVC).
Check conformity by inspection of the technical file.
ISO 20695:2020(E)
4.6 Cleaning and disinfection
If not labelled for single use, the medical device shall be capable of being cleaned, disinfected, or
sterilized, according to the manufacturer's instructions, without affecting the ability of the medical
device to meet the requirements of this document throughout its claimed use life.
NOTE ISO 17664 provides requirements and guidance for information provided by the supplier for the
processing of reusable medical devices.
Check conformity by inspection of the technical file.
4.7 Sterility
All devices supplied as "STERILE" shall be sterilized using a sterilization process that has been validated
and is routinely controlled in accordance with an International Standard for the applicable method
−6
of sterilization to demonstrate achievement of a maximal sterility assurance level (SAL) of 10 , i.e.
applicable parts of ISO 17665-1, ISO 11135, ISO 11137-1, ISO 25424 or ISO 14937.
Check conformity by inspection of the technical file.
4.8 Packaging
All medical devices supplied and marked as “STERILE” shall be contained in a packaging system
conforming to ISO 11607-1 and ISO 11607-2.
Check conformity by inspection of the technical file.
4.9 Biological safety
Enteral feeding systems shall be evaluated for biological safety in accordance with ISO 10993-1.
Check conformity by inspection of the technical file.
4.10 Corrosion resistance
Any metallic component exposed to the patient or in contact with enteral fluids or substances shall be
manufactured from corrosion resistant materials.
Check conformity by the test given in Annex B.
4.11 Surface finish
External surfaces of the parts of the enteral devices that are inserted into the body shall be free from-
extraneous matter and process and surface defects that can present an unacceptable risk of patient harm.
Check conformity by visual inspection by normal or corrected vision under a minimum
2,5 × magnification under an illuminance of 215 ± 5 lx.
4.12 Information supplied by the manufacturer
4.12.1 Marking
If present, markings on the devices shall be clearly legible and durable.
Check conformity by rubbing the markings, without undue pressure, with a cloth soaked in either
ethanol or isopropanol.
Verify that the markings can be viewed from a distance of 50 cm ± 10 cm by an operator having a
normal or corrected-to-normal vision.
4 © ISO 2020 – All rights reserved
ISO 20695:2020(E)
4.12.2 Symbols
Symbols should be used where appropriate and shall be in accordance with ISO 15223-1 or ISO 7000.
If symbols that are used are not defined in either of these International Standards, national or regional
standards may be used or the symbols shall be described in the instructions for use (see 4.12.4 g).
Check conformity by inspection.
4.12.3 Labelling
The information provided on enteral feeding system labelling shall conform to relevant international
and national requirements for those medical devices. The packaging (sterile barrier system and/or
packaging system) shall be labelled with the following information as a minimum:
a) the name or trade name of the enteral feeding device;
b) the name and address of the manufacturer and, where appropriate, the name and address of the
manufacturers' authorized representative;
c) the details necessary for the user to identify the enteral feeding device or contents of the packaging;
d) where appropriate, the word "STERILE" and the method used to sterilize the enteral feeding device;
e) the batch code, preceded by the word "LOT";
f) an indication of the date by which the enteral feeding device should be used, expressed at least as
the year and month;
g) any special storage or handling conditions;
h) if appropriate, an indication that the device is for single patient use (a manufacturer's indication of
single use shall be consistent across its range).
NOTE Applicable regulatory requirements for Unique Device Identifier (UDI) can apply.
4.12.4 Instructions for use
If present, the instructions for use shall include at least the following information:
a) where appropriate, an indication that the device is for single use or single patient use (a
manufacturer's indication of single use shall be consistent across its range);
b) any special operating instructions required for safe and effective use of the device;
c) any specific warnings or precautions;
d) where applicable, the method of cleaning, disinfecting or sterilization necessary prior to use;
e) where applicable, Magnetic Resonance Imaging (MRI) compatibility information;
f) the date of issue or the revision level of the instructions for use;
g) where applicable, a description of any symbols used on the device or labelling (see 4.12.2 and
4.12.3).
ISO 20695:2020(E)
5 Additional requirements for enteral giving sets and enteral extension sets
5.1 General
Enteral giving sets and enteral extension sets shall consist of the following:
a) inlet port(s) or reservoir(s);
b) tubing;
c) outlet port.
Enteral giving sets may also include other features such as the following:
1) an access port;
2) a drip chamber;
3) a pump insert;
4) a means for regulating and/or stopping the flow through the enteral giving set.
See Figure 1.
5.2 Inlet ports
5.2.1 The inlet port of an enteral giving set shall be:
a) a reservoir connector conforming to ISO 18250-3:2018, Figure B.1 and Table B.1 or Figure B.6 and
Table B.6;
b) a wide neck screw cap; or
c) a crown-cork cap.
NOTE 1 This does not apply if the reservoir is an integral part of the enteral giving set.
NOTE 2 Examples of screw caps and necks are defined in DIN 55525:1988, ASTM D2911-94 (reapproved
2001), DIN 6063-1:2011, DIN 6063-2:2011, DIN 168-1:1998. Examples of crown cork caps and necks are defined
in DIN 6094-1:1982, ISO 12821, EN 14635.
5.2.2 The inlet port of an enteral extension set shall be:
a) a male enteral small-bore connector conforming to ISO 80369-3;
or alternatively
b) a connector conforming to ISO 80369-1.
5.3 Outlet ports
5.3.1 The outlet port of an enteral giving set shall be:
a) a female enteral small-bore connector conforming to ISO 80369-3; or alternatively;
b) a connector conforming to ISO 80369-1.
5.3.2 The outlet port of an enteral extension set shall be:
a) a female small-bore connector conforming to ISO 80369-3; or alternatively;
6 © ISO 2020 – All rights reserved
ISO 20695:2020(E)
b) a connector conforming to ISO 80369-1.
5.4 Access ports
If an access port of the enteral giving set is provided it shall be either:
a) a male connector conforming to ISO 80369-3;
or alternatively
b) a connector conforming to the requirements of ISO 80369-1.
5.5 Tensile strength
Enteral giving sets and enteral extension sets (including tubing, joints, and connections) shall withstand
a tensile force of 15 N before breaking, becoming detached, or cracking.
Check conformity by the test method given in Annex C.
5.6 Leakage
5.6.1 Enteral giving sets shall not show signs of leakage sufficient to form a falling drop of water while
being subjected to the internally applied pressure given in 5.6.2 and 5.6.3.
5.6.2 For enteral giving sets not designed for use with an enteral feeding pump, applied pressure shall
be between 20 kPa and 22 kPa over a hold period of 30 s to 35 s.
5.6.3 For enteral giving sets designed for use with an enteral feeding pump, applied pressure shall be:
a) distal to the driving mechanism of the pump — between 200 kPa and 220 kPa or greater than the
maximum operating pressure of the pump with which they are designed to be used over a hold
period of 120 s to 130 s; and
b) proximal to the driving mechanism of the pump — between 20 kPa and 22 kPa over a hold period
of 30 s to 35 s.
Check conformity by test method given in Annex D.
5.7 Additional information provided by the manufacturer
In addition to the general labelling requirements given in 4.12.3, enteral giving sets not designed to be
used with an enteral feeding pump but designed for gravity use shall be labelled “for gravity use”.
Check conformity by visual inspection.
ISO 20695:2020(E)
Key
1 inlet port(s) or reservoir(s) 6 optional driving mechanism of the pump
2 tubing 7 optional means for regulating and/or stopping the flow
3 outlet port 8 optional dust cap or closure
a
4 optional access port Proximal side of the enteral giving set/enteral extension set.
b
5 optional drip chamber Distal side of the enteral giving set/enteral extension set.
Figure 1 — Example of enteral giving sets/extension sets with optional access port
8 © ISO 2020 – All rights reserved
ISO 20695:2020(E)
6 Additional requirements for enteral syringes
6.1 General
Enteral syringes shall consist of at least the following:
a) a graduated container;
b) unless the enteral syringe is designed for gravity use, there shall be a means to create pressure (e.g.
a plunger or a bulb);
c) an outlet port.
6.2 Outlet port
The outlet port of an enteral syringe shall be either:
a) a female connector conforming to ISO 80369-3; or
b) a connector conforming to the requirements of ISO 80369-1.
NOTE An example of an alternative enteral syringe tip is provided in Annex K.
6.3 Enteral syringe requirements
Enteral syringes shall conform to ISO 7886-1:2017 and ISO 7886-2:1996 as listed in Tables 1 and 2.
Table 1 — Enteral syringe requirements in accordance with ISO 7886-1:2017
Clause/subclause Subject Applicability
5 General requirements All syringe types
6.2 Limits for acidity or alkalinity All syringe types
6.3 Limits for extractable metals All syringe types
7 Lubricant Only for syringes with a plunger
8 Tolerance on graduated scale All syringe types
9 Graduated scale All syringe types
10 Barrel Only for syringes with a plunger
11 Plunger stopper/plunger assembly Only for syringes with a plunger
12.2 Position of nozzle on end of barrel All syringe types
13.2 Freedom from air and liquid leakage past Only for syringes with a plunger
plunger stopper
13.3 Force to operate the piston Only for syringes with a plunger
ISO 20695:2020(E)
Table 2 — Enteral syringe requirements in accordance with ISO 7886-2:1996
Clause/subclause Subject Comment
11 Syringe design Only for syringes with a plunger for
fitment to a syringe pump
12 Piston/plunger assembly Only for syringes with a plunger for
fitment to a syringe pump
14.3 Flow characteristics Only for syringes with a plunger
for fitment to a syringe pump
14.4 Conformity of syringe Only for syringes with a plunger
for fitment to a syringe pump
14.5 Plunger movement forces Only for syringes with a plunger
for fitment to a syringe pump
Check conformity by inspection of technical file.
6.4 Enteral Syringe dose accuracy requirement
Risk management shall be applied to the dose accuracy of the delivery from an enteral syringe to an
access port (see A.2.5).
6.5 Marking
The syringe shall be marked to identify that it is for enteral application.
Check conformity by inspection.
7 Additional requirements for enteral feeding catheters
7.1 General
7.1.1 Enteral feeding catheters shall consist of at least the following:
a) access port(s);
b) tubing.
7.1.2 Enteral feeding catheters may also include other features, such as:
a) a closure cap;
b) a balloon inflation port;
c) an integral introducer;
d) a means for regulating and/or stopping the flow through the enteral feeding catheter;
e) a weight;
f) a stylet;
g) an external retention bolster;
h) an internal retention mechanism (e.g. balloon, bumper, pigtail).
10 © ISO 2020 – All rights reserved
ISO 20695:2020(E)
7.2 Access ports
7.2.1 Access port(s) at the proximal end of enteral feeding catheters shall be either:
a) a male connector conforming to ISO 80369-3; or
b) a connector conforming to the requirements of ISO 80369-1.
Access ports on skin level enteral feeding catheters are specifically excluded from this requirement, but
manufacturers should check its non-interconnectability based on ISO 80369-1, and assess its risks.
7.2.2 Enteral feeding catheters designed for large volume access, with internal lumens larger than
6,90 mm , may include two proximal access ports. At least one of those ports shall conform to 7.2.1.
The manufacturer should identify in the labelling the intended use of any additional proximal access ports.
7.3 Tensile properties
7.3.1 Enteral feeding catheters designed for use without an integral introducer system
Enteral feeding catheters (including all joints and connections) sh
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