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

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Status
Published
Publication Date
17-Dec-2019
Current Stage
6060 - International Standard published
Start Date
18-Dec-2019
Completion Date
18-Dec-2019
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ISO 18241:2016/Amd 1:2019 - Connectors
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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
---------------------- Page: 1 ----------------------
ISO 18241:2016/Amd.1:2019(E)
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© ISO 2019

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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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electrotechnical standardization.

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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
---------------------- Page: 3 ----------------------
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
---------------------- Page: 5 ----------------------
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)
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
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
Other L Minimum length of engagement 4,665 4,050
dimensions
Tolerance for length of engagement of the female
M 0,750 0,750
conical fitting
Tolerance for length of engagement of the male
N 1,083 1,700
conical fitting
R Radius of curvature (maximum) 0,5 0,5
Dimensions L, M and N are derived from the basic dimensions.
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
...

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