ISO 15674:2016/Amd 1:2020

Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags — Amendment 1: Connectors

Implants cardiovasculaires et organes artificiels — Systèmes réservoirs de cardiotomie/veineux à paroi dure (avec/sans filtre) et sacs réservoirs veineux mous — 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 15674:2016 - Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
• Effective Date: 04-Dec-2021

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 15674
Third edition
2016-08
AMENDMENT 1
2020-02
Cardiovascular implants and artificial
organs — Hard-shell cardiotomy/
venous reservoir systems (with/
without filter) and soft venous
reservoir bags
AMENDMENT 1: Connectors
Implants cardiovasculaires et organes artificiels — Systèmes
réservoirs de cardiotomie/veineux à paroi dure (avec/sans filtre) et
sacs réservoirs veineux mous
AMENDEMENT 1: Raccords
Reference number
ISO 15674:2016/Amd.1:2020(E)
©
ISO 2020

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ISO 15674:2016/Amd.1:2020(E)

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ii © ISO 2020 – All rights reserved

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ISO 15674:2016/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
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
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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 2020 – All rights reserved iii

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ISO 15674:2016/Amd.1:2020(E)
Cardiovascular implants and artificial organs — Hard-
shell cardiotomy/venous reservoir systems (with/without
filter) and soft venous reservoir bags
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 B.1 through B.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 B 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,
using the reference fittings given in Annex B.
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 B
Add the following annex after Annex A, before the Bibliography:
© ISO 2020 – All rights reserved 1

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ISO 15674:2016/Amd.1:2020(E)

Annex B
(informative)

Examples of connectors and reference fittings
B.1 Luer Slip Fittings
B.1.1 Figures B.1 and B.2 depict Luer slip fittings. For corresponding dimensions, see Table B.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 B.1.
Figure B.1 — Typical 6 % (Luer) conical fittings
NOTE See Key and dimensions given in Table B.1.
Figure B.2 — Typical assembly of 6 % (Luer) conical fittings
2 © ISO 2020 – All rights reserved

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ISO 15674:2016/Amd.1:2020(E)

Table B.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 fitting
min. 3,925 3,925
(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
Basic
D
Maximum diameter at the opening of the female conical
dimensions 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
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 con-
a
M 0,750 0,750
Other
ical fitting
dimensions
a
N Tolerance for length of engagement of the male conical fitting 1,083 1,700
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.
B.1.2 Gauging test
B.1.2.1 When tested in accordance with B.1.2.4, the conical fitting should satisfy the requirements
specified in B.1.2.2 and B.1.2.3.
B.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 ev
...