ISO 18241:2016/Amd 1:2019

Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps — Amendment 1: Connectors

Implants cardiovasculaires et systèmes extracorporels — Systèmes de pontage cardiopulmonaire — Pièges à bulles veineuses — Amendement 1: Raccords

General Information

• Status: Published
• Publication Date: 17-Dec-2019
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
• Drafting Committee: ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
• Current Stage: 6060 - International Standard published
• Start Date: 18-Dec-2019
• Due Date: 04-Oct-2020
• Completion Date: 18-Dec-2019

Relations

• Amends: ISO 18241:2016 - Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps
• Effective Date: 01-Jan-2022

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 18241
First edition
2016-08-15
AMENDMENT 1
2019-12
Cardiovascular implants and
extracorporeal systems —
Cardiopulmonary bypass systems —
Venous bubble traps
AMENDMENT 1: Connectors
Implants cardiovasculaires et systèmes extracorporels — Systèmes de
pontage cardiopulmonaire — Pièges à bulles veineuses
AMENDEMENT 1: Raccords.
Reference number
ISO 18241:2016/Amd.1:2019(E)
©
ISO 2019

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ISO 18241:2016/Amd.1:2019(E)

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ii © ISO 2019 – All rights reserved

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ISO 18241:2016/Amd.1:2019(E)

Foreword
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bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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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).
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on the ISO list of patent declarations received (see www .iso .org/ patents).
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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 Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 2, Cardiovascular implants and extracorporeal systems.
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 2019 – All rights reserved iii

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ISO 18241:2016/Amd.1:2019(E)
Cardiovascular implants and extracorporeal systems —
Cardiopulmonary bypass systems — Venous bubble traps
AMENDMENT 1: Connectors
Clause 2
Add:
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
4.2.3 Connectors
Replace the text with the following:
Connectors for connection to the blood pathway shall, when tested in accordance with 5.3.3, allow a
secure connection.
NOTE 1 Connectors of a type that allows connection of tubes with an inner diameter of 4,8 mm, 6,3 mm, 9,5 mm
or 12,7 mm, or a type that complies with ISO 8637-1:2017, Figure 1, or a type that complies with ISO 80369-7 have
been found satisfactory.
NOTE 2 Connectors with dimensions as given in Annex A (formerly defined by ISO 594-1 and ISO 594-2) and
fitting to functional gauges and reference steel fittings is a way to be in accordance with this requirement.
Performance testing of the connectors shall be performed according to ISO 80369-7, Clause 6, using the
reference fittings given in Annex A.
Annex A
Add the following annex before the Bibliography:
© ISO 2019 – All rights reserved 1

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ISO 18241:2016/Amd.1:2019(E)

Annex A
(informative)

Examples of connectors
A.1 Luer slip fittings
A.1.1 Figures A.1 and A.2 depict Luer slip fittings. For corresponding dimensions, see Table A.1.
a) Male 6 % (Luer) conical fitting (“male fitting”)
b) Female 6 % (Luer) conical fitting (“female fitting”)
NOTE See Key and dimensions in Table A.1.
Figure A.1 — Typical 6 % (Luer) conical fittings
NOTE See Key and dimensions in Table A.1.
Figure A.2 — Typical assembly of 6 % (Luer) conical fittings
2 © ISO 2019 – All rights reserved

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ISO 18241:2016/Amd.1:2019(E)

Table A.1 — Dimensions of 6 % (Luer) conical fittings
Dimensions, in mm
Reference Designation
Rigid Semi-rigid
material material
A Male fitting N/A N/A
B Female fitting N/A N/A
Basic Minimum diameter of the end of the male conical fitting
min. 3,925 3,925
dimensions (reference diameter)
d
max. Maximum diameter at the end of the male conical fitting 3,990 4,027
min. Minimum diameter at the opening of the female conical fitting 4,270 4,270
D
Maximum diameter at the opening of the female conical
max. 4,315 4,315
fitting
E Minimum length of the male conical fitting 7,500 7,500
F Minimum depth of the female conical fitting 7,500 7,500
a
Other L Minimum length of engagement 4,665 4,050
dimensions
Tolerance for length of engagement of the female
a
M 0,750 0,750
conical fitting
Tolerance for length of engagement of the male
a
N 1,083 1,700
conical fitting
b
R Radius of curvature (maximum) 0,5 0,5
a
Dimensions L, M and N are derived from the basic dimensions.
b
Or equivalent entry chamfer without any sharp corners.
A.1.2 Gauging test
A.1.2.1 When tested in accordance with A.1.2.4, the conical fitting should satisfy the requirements
specified in A.1.2.2 and A.1.2.3.
A.1.2.2 The small end of the male conical fitting should lie between the two limit planes of the gauge
and the larger end of the tapered portion should extend beyond the datum plane of the gauge. Rocking
should not be evident between the gauge and the fitting made of rigid material undergoing test.
A.1.2.3 The plane of the maxim
...