ISO 15675:2016/Amd 1:2020

Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters — Amendment 1: Connectors

Implants cardiovasculaires et organes artificiels — Systèmes de pontage cardio-pulmonaire — Filtres en ligne pour sang artériel — Amendement 1: Raccords

General Information

• Status: Published
• Publication Date: 16-Feb-2020
• 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/WG 4 - Blood gas exchangers
• Current Stage: 6060 - International Standard published
• Start Date: 17-Feb-2020
• Due Date: 04-Oct-2020
• Completion Date: 17-Feb-2020

Relations

• Amends: ISO 15675:2016 - Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
• Effective Date: 25-Apr-2020

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 15675
Third edition
2016-08
AMENDMENT 1
2020-02
Cardiovascular implants and artificial
organs — Cardiopulmonary bypass
systems — Arterial blood line filters
AMENDMENT 1: Connectors
Implants cardiovasculaires et organes artificiels — Systèmes de
pontage cardio-pulmonaire — Filtres en ligne pour sang artériel
AMENDEMENT 1: Raccords
Reference number
ISO 15675:2016/Amd.1:2020(E)
©
ISO 2020

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ISO 15675:2016/Amd.1:2020(E)

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ii © ISO 2020 – All rights reserved

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ISO 15675:2016/Amd.1:2020(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
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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
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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 2020 – All rights reserved iii

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ISO 15675:2016/Amd.1:2020(E)
Cardiovascular implants and artificial organs —
Cardiopulmonary bypass systems — Arterial blood line
filters
AMENDMENT 1: Connectors
4.2.3 Connectors
Replace the text of 4.2.3 with the following text:
Connectors for connection to the blood pathway shall, when tested in accordance with 5.3.3, allow
a secure connection (see Figures A.1 through A.11 for examples of connectors).
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, 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 and fitting to functional gauges and
reference steel fittings is a way to comply with this requirement.
Performance testing of the connectors shall be performed according to ISO 80369-7: 2016, Clause 6.
The reference fittings given in Annex A can be used in the performance testing of the connectors.
Normative references
Add:
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7:
Connectors for intravascular or hypodermic applications
Annex A
Add the following annex, before the Bibliography:
© ISO 2020 – All rights reserved 1

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ISO 15675:2016/Amd.1:2020(E)

Annex A
(informative)

Examples of connectors and reference fittings
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 given in Table A.1.
Figure A.1 — Typical 6 % (Luer) conical fittings
NOTE See Key and dimensions given in Table A.1.
Figure A.2 — Typical assembly of 6 % (Luer) conical fittings
2 © ISO 2020 – All rights reserved

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ISO 15675:2016/Amd.1:2020(E)

Table A.1 — Dimensions of 6 % (Luer) conical fittings
Dimension
(length in mm)
Reference Designation
Rigid Semi-rigid
material material
A Male fitting N/A N/A
B Female fitting N/A N/A
Minimum diameter of the end of the male conical
min. 3,925 3,925
fitting (reference diameter)
d
Maximum diameter at the end of the male
max. 3,990 4,027
conical fitting
Minimum diameter at the opening of the female
min. 4,270 4,270
Basic
conical fitting
D
dimensions
Maximum diameter at the opening of the female
max. 4,315 4,315
conical 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
G Maximum outside diameter of female conical fitting 6,730 6,730
a
L Minimum length of engagement 4,665 4,050
Tolerance for length of engagement of the female
a
M 0,750 0,750
conical fitting
Other
dimensions
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 f
...