kSIST FprEN ISO 80369-1:2025

SLOVENSKI STANDARD
oSIST prEN ISO 80369-1:2023
01-september-2023
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 1. del:
Splošne zahteve (ISO/DIS 80369-1:2023)
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General
requirements (ISO/DIS 80369-1:2023)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO/DIS 80369-
1:2023)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
1: Exigences générales (ISO/DIS 80369-1:2023)
Ta slovenski standard je istoveten z: prEN ISO 80369-1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 80369-1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 80369-1:2023
oSIST prEN ISO 80369-1:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80369-1
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-06-21 2023-09-13
Small-bore connectors for liquids and gases in healthcare
applications —
Part 1:
General requirements
ICS: 11.040.20; 11.040.10
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
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NATIONAL REGULATIONS.
ISO/DIS 80369-1:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 80369-1:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80369-1
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:

Small-bore connectors for liquids and gases in healthcare
applications —
Part 1:
General requirements
ICS: 11.040.20; 11.040.10
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 80369-1:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 80369-1:2023
ISO 80369-1:2023(E)
1 Contents
2 Foreword . 5
3 Introduction. 6
4 1 Scope . 8
5 2 Normative references . 8
6 3 Terms and definitions. 9
7 4 Small-bore connector non-interconnectable requirement . 12
8 5 Small-bore connectors for clinical applications . 12
9 5.1 Small-bore connectors for new clinical applications . 12
10 5.2 Small-bore connectors for respiratory applications. 12
11 5.3 Small-bore connectors for enteral applications . 13
12 5.4 Small-bore connectors for limb cuff inflation applications . 13
13 5.5 Small-bore connectors for neural applications . 13
14 5.6 Small-bore connectors for intravascular and hypodermic applications . 13
15 5.7 Other use cases utilizing an ISO 80369-7 small-bore connector . 13
16 6 Alternative small-bore connectors . 15
17 Annex A (informative) Rationale . 16
18 Annex B (normative) Process for demonstrating non-interconnectable characteristics . 21
19 Figure B.1 — Illustration of the process to evaluate the non-interconnectable characteristics . 22
20 Figure B.2 — Example of typical fixed collar cone connector diameters to be evaluated . 23
21 Figure B.3 — Example of typical full threaded socket connector diameters to be evaluated . 24
22 Figure B.4 — Example of a typical rib diameter to be evaluated . 24
23 Figure B.5 — Example of a typical connector with a lug to be evaluated . 25
24 Figure B.6 — Example of a typical cylinder-to-cylinder interface to be evaluated . 25
25 Figure B.7 — Example of a typical cylinder to full thread interface to be evaluated . 26
26 Figure B.8 — Example of a typical cylinder to full thread interface to be evaluated (cross-section
27 view) 26
28 Figure B.9 — Example of a typical cylinder to external lug interface to be evaluated . 26
29 Figure B.10 — Example of a typical cylinder to external lug interface to be evaluated (cross-
30 section view) . 27
31 Annex C (normative) Assessment procedures for small-bore connectors . 35
32 Annex D (informative) Applications of small-bore connectors and the relevant standard . 38
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oSIST prEN ISO 80369-1:2023
ISO 80369-1:2023(E)
33 Annex E (informative) Design assessment summary . 40
34 Annex F (informative) Reference to the Essential Principles . 43
35 Bibliography . 50
36 Alphabetical index of defined terms . 51
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oSIST prEN ISO 80369-1:2023
ISO 80369-1:2023(E)
38 Foreword
39 ISO (the International Organization for Standardization) is a worldwide federation of national standards
40 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
41 through ISO technical committees. Each member body interested in a subject for which a technical
42 committee has been established has the right to be represented on that committee. International
43 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
44 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
45 electrotechnical standardization.
46 The procedures used to develop this document and those intended for its further maintenance are
47 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
48 different types of ISO documents should be noted. This document was drafted in accordance with the
49 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
50 Attention is drawn to the possibility that some of the elements of this document may be the subject of
51 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
52 patent rights identified during the development of the document will be in the Introduction and/or on
53 the ISO list of patent declarations received (see www.iso.org/patents).
54 Any trade name used in this document is information given for the convenience of users and does not
55 constitute an endorsement.
56 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
57 expressions related to conformity assessment, as well as information about ISO's adherence to the World
58 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
59 www.iso.org/iso/foreword.html.
60 This document was prepared by Technical Committee ISO/TC 210, Quality management and
61 corresponding general aspects for medical devices, in collaboration with IEC/TC 62, Electrical equipment
62 in medical practice, Subcommittee SC D, Electromedical equipment and CEN/CENELEC TC 3/WG 2, Small-
63 bore connectors.
64 This third edition cancels and replaces the second edition (ISO 80369-1:2018), which has been
65 technically revised.
66 The main changes compared to the previous edition are as follows:
67 — the normative references have been updated;
68 — reformatted according to most recent Central Secretariat editing rules;
69 — added respiratory applications; and
70 — extended the use of the ISO 80369-7 connector to medical devices and accessories beyond
71 intravascular and hypodermic applications where the risk is acceptable.
72 A list of all parts in the ISO and IEC 80369 series can be found on the ISO and IEC websites.
73 Any feedback or questions on this document should be directed to the user’s national standards body. A
74 complete listing of these bodies can be found at www.iso.org/members.html.
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oSIST prEN ISO 80369-1:2023
ISO 80369-1:2023(E)
75 Introduction
76 In the 1990s, concern grew regarding the proliferation of medical devices fitted with Luer connectors as
77 specified in ISO 594 series and the reports of patient death or injury arising from unintended connections
78 that resulted in the inappropriate delivery of fluids and gases via incorrect routes. In addition to clinical
79 and workplace protocols and warnings, attention was turned to engineering solutions to reduce the
80 probability of wrong route administration of liquids and gases.
81 Concerns regarding the use of Luer connectors with enteral feeding tubes and gas sampling and gas
82 delivery systems were raised with CEN/BT and the European Commission. In November 1997, the newly
83 created CHeF steering group set up a Forum Task Group (FTG) to consider the problem.
[7]
84 The FTG produced CEN Report, CR 13825 , in which they concluded that there is a problem arising from
85 the use of a single connector design to several different applications. In a coronary care unit, there were
86 as many as 40 Luer connectors on the medical devices used with a single patient until the use of connectors
87 defined in the ISO and IEC 80369 documents started to be established. Therefore, it is not surprising that
88 unintended connections were made.
89 Medical devices have, for many years, followed the established principle of “safety under single fault
90 conditions.” Simply stated, this means that a single fault should not result in an unacceptable risk. This
[5]
91 principle is embodied in the requirements of numerous medical device standards . Extending this
92 principle to the use of Luer connectors (i.e., that an unintended connection should not result in an
93 unacceptable risk to a patient) the FTG recommended that the Luer connector should be restricted to
94 medical devices intended to be connected to the vascular system or a hypodermic syringe. In addition, the
95 FTG recommended that new designs of small-bore connectors should be developed for other applications,
96 and these should be non-interconnectable with Luer connectors and each other.
97 ISO 16142-1:2016 addresses this type of problem in Essential Principle 2 of Table B.1:
98 The solutions adopted by the manufacturer for the design and manufacture of the medical
99 device should conform to safety principles, taking into account the generally acknowledged
100 state of the art. When risk reduction is required the manufacturer should control the risks so
101 that the residual risk associated with each hazard is judged acceptable. The manufacturer
102 should apply the following principles in the priority order listed:
103 a) identify known or foreseeable hazards and estimate the associated risks arising from the
104 intended use and foreseeable misuse;
105 b) eliminate risks as far as reasonably practicable through inherently safe design and
106 manufacture;
107 c) reduce as far as reasonably practicable the remaining risks by taking adequate protection
108 measures, including alarms, or information for safety;
109 d) inform users of any residual risk.
110 It is understood that small-bore connector systems cannot be designed to overcome all chances of
111 unintended connections and potential for wrong route administration or to eliminate deliberate misuse.
112 With these application-specific connectors now available, there is a much safer environment for patients
113 and the potential of unintended connections is reduced with reduction of the risk of wrong route
114 administration and thus improved patient safety. Introduction of medical devices and accessories utilizing
115 these small-bore connectors is progressing albeit slowly.
116 The risks associated with unintended connections and subsequent wrong route administration of liquids
117 and gasses cannot be fully assessed until these small-bore connectors are part of a medical device or
118 accessory. Therefore, the intended applications specified are recommendations. It is expected that
119 particular medical device standards will reference the connectors from the relevant parts of the ISO and
120 IEC 80369 series if considered appropriate.
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oSIST prEN ISO 80369-1:2023
ISO 80369-1:2023(E)
121 This document contains the general requirements to reduce connections between small-bore connectors
122 used in different applications as well as specifying those applications.
123 It specifies the general requirements and test methods for assessing the non-interconnectable
124 characteristics of small-bore connectors within the ISO and IEC 80369 series.
125 The Luer connector as originally defined in the withdrawn ISO 594 series has been widely used on many
126 medical devices and accessories and in a wide range of clinical applications for many years. The clinical
127 applications that present the highest risk to a patient from wrong route administration of liquids and
128 gases have been identified and are those included in the application parts of the ISO and IEC 80369 series.
129 ISO 80369-7, which replaces the ISO 594 series (i.e., the Luer connector), is intended for use with
130 intravascular or hypodermic applications.
131 However, there are currently medical devices and accessories which incorporate a Luer connector, but do
132 not fall into any of the applications specified by the ISO and IEC 80369 series. There are also some medical
133 devices and accessories within the applications of the ISO and IEC 80369 series applications that
134 incorporate a Luer connector. Those that present no unacceptable risk to the patient from an unintended
135 connection to a medical device or accessory within intravascular or hypodermic application are suitable
136 for consideration for the use of the Luer connector as specified in ISO 80369-7.
137 ISO 80369-20 specifies the common test methods for assessing the basic performance requirements
138 specified in ISO 80369-2 to ISO 80369-7 for small-bore connectors.
139 ISO 80369-2 to ISO 80369-7 specify the dimensional requirements for the interfaces of the connectors
140 and the specific performance requirements for assessing the interconnectability of the connector-mating
141 halves.
142 The designs and dimensions of small-bore connectors specified in ISO 80369-2 to ISO 80369-7 have been
143 successfully assessed according to the requirements of this document (i.e. have been proven to be
144 acceptable with regard to the risk of misconnection with the other connectors of this series).
145 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
146 of the conditions is true.
147 In this document the following verbal forms are used:
148 — “shall” indicates a requirement;
149 — “should” indicates a recommendation;
150 — “may” indicates a permission;
151 — "can" is used to describe a possibility or capability.
152 Requirements in this document have been decomposed so that each requirement is uniquely delineated.
153 This is done to support automated requirements tracking.
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oSIST prEN ISO 80369-1:2023
ISO 80369-1:2023(E)
155 Small-bore connectors for liquids and gases in healthcare
156 applications —Part 1: General requirements
157 1 Scope
158 NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2.
159 This document specifies general requirements for small-bore connectors that form part of a medical device
160 or accessory that conveys liquids or gases to a patient.
161 This document also identifies the applications for which these small-bore connectors are intended to be
162 used, which include, but are not limited to:
163 — respiratory;
164 — enteral;
165 — limb cuff inflation;
166 — neural;
167 — intravascular or hypodermic.
168 This document provides the methodology to assess non-interconnectable characteristics of small-bore
169 connectors based on their inherent design in order to reduce the risk of misconnections between medical
170 devices or between accessories for different applications as specified in this document as well as those
171 that might be developed under future parts of the ISO and IEC 80369 series.
172 This document specifies the small-bore connector-related interface requirements for the medical devices
173 and accessories that use these small-bore connectors.
174 These interface requirements reduce the risk of wrong route administration of liquids or gases between
175 the medical device or accessory by incorporating these small-bore connectors in different applications.
176 NOTE 2 6.1 allows for additional designs of small-bore connectors for inclusion in the ISO and IEC 80369 series.
177 NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO and
178 IEC 80369 series into medical devices, medical systems or accessories, even if currently not required by the relevant
179 particular medical device standards. It is expected that when the relevant particular medical device standards are
180 revised, the risks associated with changing to the new small-bore connectors as specified in the ISO and IEC 80369
181 series of documents will be considered.
182 NOTE 4 Manufacturers and other entities including those accountable for the use of a medical device and the
183 clinical incident monitoring are encouraged to report their experience with the small-bore connectors specified in
184 the ISO and IEC 80369 series to the Committee Manager of ISO/TC 210 so that this feedback can be considered
185 during the revision of the relevant part of the ISO and IEC 80369 series.
186 2 Normative references
187 The following documents are referred to in the text in such a way that some or all of their content
188 constitutes requirements of this document. For dated references, only the edition cited applies. For
189 undated references, the latest edition of the referenced document (including any amendments) applies.
190 ISO 14971:2019, Medical devices — Application of risk management to medical devices
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oSIST prEN ISO 80369-1:2023
ISO 80369-1:2023(E)
191 ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
192 ISO 80369-2:— , Small-bore connectors for liquids and gases in healthcare applications — Part 2:
193 Connectors for respiratory applications
194 ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors
195 for enteral applications
196 IEC 80369-5, Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors
197 for limb cuff inflation applications
198 ISO 80369-6, Small-bore connectors for liquids and gases in healthcare applications — Part 6: Connectors
199 for neural applications
200 ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
201 for intravascular or hypodermic applications
202 IEC 62366-1:2015+AMD1:2020, Medical devices — Part 1: Application of usability engineering to medical
203 devices
204 3 Terms and definitions
205 For the purposes of this document, the terms and definitions given in ISO 14971:2019 and
206 IEC 62366-1:2015+AMD1:2020 and the following apply.
207 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
208 — ISO Online browsing platform: available at https://www.iso.org/obp
209 — IEC Electropedia: available at https://www.electropedia.org/
210 3.1
211 accessory
212 additional part(s) for use with a medical device in order to:
213 — achieve the intended use;
214 — adapt it to some special use;
215 — facilitate its use;
216 — enhance its performance; or
217 — enable its functions to be integrated with those of other medical devices
218 [SOURCE: IEC 60601-1:2005, 3.3, modified — replaced “equipment” with “a medical device”.]
219 3.2
220 application
221 specific healthcare use
222 Note 1 to entry: Annex D lists examples of uses of the applications of small-bore connectors.

Under preparation. Stage at the time of publication: ISO/FDIS 80369-2:2023.
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oSIST prEN ISO 80369-1:2023
ISO 80369-1:2023(E)
223 3.3
224 connection
225 union or joining of two connectors (3.4)
226 3.4
227 connector
228 part of a medical device, consisting of one of two mating halves and designed to join a conduit to convey
229 liquids or gases
230 3.5
231 contactable surface
232 any surface on a connector (3.4) that has an interaction potential in which physical contact occurs with
233 any other surface on an opposing connector
234 Note 1 to entry: Contactable surfaces may include, but are not limited to, sealing surfaces as intended by design,
235 crest geometry of external or internal threads, faces, shrouds, grips, etc. These are surfaces on a connector that can
236 possibly interact with another connector.
237 3.6
238 information for safety
239 information provided to the user or responsible organization as a risk control measure
240 EXAMPLE 1 Warnings, precautions or contraindications.
241 EXAMPLE 2 Instructions for the use of a medical device or accessory to prevent use error or avoid a hazardous
242 situation.
243 EXAMPLE 3 Explanation of a safety feature of a medical device.
244 Note 1 to entry: Information for safety may be found in any or all types of information supplied by the manufacturer.
245 Note 2 to entry: Information for safety can be located on the display of a medical device.
246 [SOURCE: ISO 20417:2021, 3.9]
247 3.7
248 instructions for use
249 IFU
250 portion of the accompanying information that is essential for the safe and effective use of a medical device
251 or accessory (3.1) directed to the user of the medical device
252 Note 1 to entry: For the purposes of this document, a user can be either a lay user or professional user with relevant
253 specialized training.
254 [SOURCE: ISO 20417:2021, 3.11, modified — deleted notes 2 to 5.]
255 3.8
256 interference test part
257 component that physically represents a small-bore (3.15) connector (3.4) or connector feature
258 Note 1 to entry: An interference test part is used to evaluate whether a contactable surface (3.5) can misconnect
259 with the small-bore connector being evaluated.
260 Note 2 to entry: Contactable surfaces are identified during the dimensional analysis per B.2.
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oSIST prEN ISO 80369-1:2023
ISO 80369-1:2023(E)
261 3.9
262 least material condition
263 LMC
264 condition in which a feature contains the least amount of material within the stated tolerance
265 EXAMPLES Maximum hole diameter, minimum shaft diameter.
266 3.10
267 Luer connector
268 small-bore (3.15) connector (3.4) that contains a conical mating surface with a 6 % (Luer) taper intended
269 for use in intravascular or hypodermic applications (3.2) of medical devices and related accessories (3.1)
270 Note 1 to entry: A Luer connector can be either a Luer slip connector or a Luer lock connector.
271 [SOURCE: ISO 80369-7:2021, 3.2, modified — deleted note 2.]
272 3.11
273 marking
274 information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical
275 device or accessory (3.1)
276 Note 1 to entry: For the purposes of this document, the term marked is used to designate the corresponding act.
277 Note 2 to entry: For the purposes of this document, marking is different from ‘direct marking’ as commonly
278 described in unique device identification (UDI) standards and regulations. A UDI ‘direct marking’ is a type of
279 marking.
280 [SOURCE: ISO 20417:2021, 3.16, modified — deleted note 3.]
281 3.12
282 maximum material condition
283 MMC
284 condition in which a feature contains the maximum amount of material within the stated tolerance
285 EXAMPLE Minimum hole diameter, maximum shaft diameter.
286 3.13
287 misconnection
288 connection (3.3) between two connectors (3.4) of a different type
289 [SOURCE: IEC 60601-1:2005+AMD1:2012+AMD2:2020, 3.69]
290 3.14
291 non-interconnectable
292 having characteristics which incorporate geometries or other features that prevent different connectors
293 (3.4) from making a connection (3.3)
294 3.15
295 patient
296 person undergoing a medical, surgical or dental procedure
297 [SOURCE: IEC 60601-1:2005+A1:2012, 3.76, modified — replaced “living being (person or animal)” with
298 “person” and deleted the note.]
299 3.16
300 small-bore
301 inner-fluid pathway of a connection (3.3) with a diameter less than 8,5 mm
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oSIST prEN ISO 80369-1:2023
ISO 80369-1:2023(E)
302 Note 1 to entry: For the purposes of this document, the 8,5 mm cone and socket of ISO 5356-1 is not considered a
303 small-bore connector
304 3.17
305 test method
306 definitive procedure for evaluating connectors (3.4) that produces a test result
307 3.18
308 unintended connection
309 connection (3.3) between two connectors (3.4) of the same type for different use cases
310 4 Small-bore connector non-interconnectable requirement
311 NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2.
312 Small-bore connectors of each application category specified in this document shall be non-
313 interconnectable with any of the small-bore connectors of every other application category unless
314 otherwise indicated within the ISO and IEC 80369 series.
315 Check conformity by confirming that objective evidence demonstrates that the acceptability criteria
316 specified in Annex B are met.
317 The use of a connector specified by the ISO and IEC 80369 series is considered as objective evidence that
318 the acceptability criteria specified in Annex B are met.
319 NOTE 2 For the purpose of this document, dimensional conformity and modulus of elasticity conformity with the
320 requirements of the various application parts of the ISO and IEC 80369 series is considered sufficient objective
321 evidence of non-interconnectable characteristics.
322 5 Small-bore connectors for clinical applications
323 NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2.
324 NOTE 2 Annex D lists examples of the sort of medical devices or accessories for which the small-bore connectors
325 within each application are intended.
326 5.1 Small-bore connectors for new clinical applications
327 Designs of small-bore connectors other than those specified in 5.2 to 5.6, for inclusion in the ISO and
328 IEC 80369 series, and used in medical devices or accessories intended for use with a patient, shall meet
329 the requirements of Annex C.
330 Check conformity by application of Annex C.
331 5.2 Small-bore connectors for respiratory applications
332 Small-bore connectors intended to be used for connections in the respiratory application shall conform
333 with:
334 ISO 80369-2, unless the use of these connectors creates an unacceptable risk for a specific medical
335 device or accessory, or
336 Clause 6.
337 Check conformity by inspection of the documentation demonstrating that the small-bore connector
338 conforms to the requirements of ISO 80369-2 or, in case of alternative connectors as per Clause 6, by
339 applying the performance tests of ISO 80369-2 using appropriate reference connectors for the alternative
340 design.
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oSIST prEN ISO 80369-1:2023
ISO 80369-1:2023(E)
341 5.3 Small-bore connectors for enteral applications
342 Small-bore connectors intended to be used for connections in the enteral application shall conform with:
343 ISO 80369-3, unless the use of these connectors creates an unacceptable risk for a specific medical
344 device or accessory, or
345 Clause 6.
346 Check conformity by inspection of the documentation demonstrating that the small-bore connector
347 conforms to the requirements of ISO 80369-3 or, in case of alternative connectors as per Clause 6, by
348 applying the performance tests of ISO 80369-3 using appropriate reference connectors for the alternative
349 design.
350 5.4 Small-bore connectors for limb cuff inflation applications
351 Small-bore connectors intended to be used for connections in limb cuff inflation application shall conform
352 with:
353 IEC 80369-5, unless the use of these connectors creates an unacceptable risk for a specific medical
354 device or accessory, or
355 Clause 6.
356 Check conformity by inspection of the documentation demonstrating that the small-bore connector
357 conforms to the requirements of IEC 80369-5 or, in case of alternative connectors as per Clause 6, by
358 applying the performance tests of IEC 80369-5 using appropriate reference connectors for the alternative
359 design.
360 5.5 Small-bore connectors for neural applications
361 Small-bore connectors intended to be used for connections in neural application shall conform with:
362 ISO 80369-6, unless the use of these connectors creates an unacceptable risk for a specific medical
363 device or accessory, or
364 Clause 6.
365 Check conformity by inspection of the documentation demonstrating that the small-bore connector
366 conforms to the requirements of ISO 80369-6 or, in case of alternative connectors as per Clause 6, by
367 applying the performance tests of ISO 80369-6 using appropriate reference connectors for the alternative
368 design.
369 5.6 Small-bore connectors for intravascular and hypodermic applications
370 Small-bore connectors intended to be used for connections in intravascular or hypodermic applications
371 shall conform with:
372 a) ISO 80369-7, unless the use of these connectors creates an unacceptable risk for a specific medical
373 device or accessory; or
374 b) Clause 6.
375 Check conformity by inspection of the documentation demonstrating that the small-bore connector
376 conforms to the requirements of ISO 80369-7 or, in case of alternative connectors as per Clause 6, by
377 applying the performance tests acceptance criteria of ISO 80369-7 using appropriate reference
378 connectors for the alternative design.
379 5.7 Other use cases utilizing an ISO 80369-7 small-bore connector
380 NOTE 1 There is guidance or rationale for this subclause contained in Clause A.2.
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oSIST prEN ISO 80369-1:2023
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381 Small-bore connectors, intended to be used for connections other than those falling into the
382 applications of 5.2, 5.3, 5.4, 5.5 and 5.6 of medical devices and accessories may conform with
383 ISO 80369-7 under the following conditions, unless the use of these connectors creates an
384 unacceptable risk for the specific medical device or accessory.
385 Such a connector shall conform with ISO 80369-7.
386 A medical device or accessory using an ISO 80369-7 connector for such use cases shall meet the
387 following requirements:
388 1) The risk of unintended connections with any reasonably foreseeable medical devices or accessories
389 using the ISO 80369-7 connector shall be:
390 i) evaluated using ISO 14971:2019; and
391 ii) determined to be an acceptable risk.
392 NOTE 2 There is guidance or rationale for this requirement contained in Clause A.2.
393 I) In determining acceptable risk, the manufacturer shall evaluate the severity of the
394 potential harm associated with the potential unintended connection with flow in both
395 directions of the connection.
396 2) Such a medical device or accessory shall be marked in accordance with ISO 20417:2021, 6.1.5.
397 3) If acceptable risk is achieved by providing information for safety, the medical device or accessory
398 shall include in its instructions for use a statement to the effect that “As this [insert name of
399 medical device or accessory here] uses an ISO 80369-7 small-bore connector for other than its
400 intended application, there is a possibility that an inadvertent connection can occur between this
401 [insert name of medical device or accessory here] and another medical device or accessory using
402 this connector, which can result in a hazardous situation causing harm to the patient. Special
403 measures need be taken by the user to mitigate these reasonably foreseeable risks."
404 4) It is recommended that the manufacturer of such a medical device or accessory that utilizes a
405 small-bore connector of the ISO 80369-7 for other than its intended application notify the
406 Committee Manager of ISO/TC 210 of their utilization.
407 i) The notification should include a description of:
408 I) the connector used;
409 II) the medical device or accessory using the connector;
410 III) the clinical procedure; and
411 IV) the fluid being used.
412 NOTE 3 This information will be used during the systematic review of this document.
413 Check conformity for a medical device or accessory using a small-bore connector of ISO 80369-7 for other
414 than the intravascular and hypodermic application by:
415 — inspection of the risk management file of the medical device or accessory using the connector and
416 confirming that the risk of any unintended connection is acceptable;
417 — inspection of the marking; and
418 — inspection of the instructions for use.

Contact information is available on the ISO website at: https://www.iso.org/committee/54892.html.
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oSIST prEN ISO 80369-1:2023
ISO 80369-1:2023(E)
419 6 Alternative small-bore connectors
420 NOTE There is guidance or rationale for this Clause contained in Clause A.2.
421 Alternative designs of small-bore connectors to those specified in Clause 6 may be used in a medical
422 device or accessory, and if used, they shall:
423 1) be evaluated according to Annex B for non-interconnectable characteristics, with the exception
424 of a connector within the same application to which it is intended to connect;
425 2) not create an unacceptable risk for a specific medical device or accessory; and
426 3) be evaluated according to the engineering analysis of Annex C.3.
427 The medical device or accessory, which incorporates an alternative design small-bore connector, shall
428 1) be marked in accordance with ISO 20417:2021, 6.1.5.
429 2) if acceptable risk is achieved by providing information for safety, include in its instructions for use
430 a statement to the effect that “As this [insert name of medical device or accessory here] uses an
431 alternative small-bore connector design different from those specified in the ISO and IEC 80369
432 series, there is a possibility that an inadvertent connection can occur between this [insert name
433 of medical device or accessory here] and a medical device or accessory using a different
434 alternative small-bore connector or that compatibility with other alternative small-bore
435 connectors might be impaired, which can result in a hazardous situation causing harm to the
436 patient. Special measures need be taken by the user to mitigate these reasonably foreseeable
437 risks.”
438 An alternative design small-bore connector that conforms with this clause:
439 1) may claim conformance with this document; but
440 2) shall not claim conformity with the other parts of the ISO and IEC 80369 series.
441 Generic claims of conformity to the ISO and IEC 80369 series shall not be made.
442 Check conformity by inspection of the risk management file of the medical device or accessory using the
443 connector and confirming that the risk of any unintended connection is acceptable. Confirm conformity
444 with Annex B and the specified portions of Annex C.
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445 Annex A
446 (informative)
448 Rationale
449 A.1 General guidance
450 This annex provides rationale for important requirements of this document and is intended for those who
451 are familiar with the subject of this document but who have not participated in its development. An
452 understanding of the reasons for the requirements is considered to be essential for its proper application.
453 Furthermore, as clinical practice and technology change, it is believed that rationale for the present
454 requirements will facilitate any revision of this document necessitated by those developments.
455 A.2 Rationale for particular clauses and subclauses
456 The numbering of the following rationales corresponds to the numbering of the clauses and subclauses
457 in this document. The numbering is, therefore, not consecutive.
458 — Clause 1  Scope
459 Advances in medicine have led to a significant rise in the number of medical devices attached to
460 patients. Many of these medical devices fall into the categories of monitoring medical devices,
461 diagnostic medical devices and drug delivery medical devices.
462 Such medical devices perform a variety of similar, but not interchangeable, functions. Examples
463 include intravenous fluid delivery, enteral feeding, respiratory gas sampling, non-invasive blood
464 pressure measurement and injection of intrathecal medication. Despite the varied nature of the
465 functions performed, many of these medical devices used a universal system of small-bore connectors
466 based on the Luer connector (6 % tapered) as formerly specified in ISO 594 series.
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