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
Standards Content (sample)
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.
---------------------- Page: 1 ----------------------
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the addressbelow or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 2 ----------------------
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
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters ofelectrotechnical 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/oron the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does notconstitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
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, SubcommitteeSC 2, Cardiovascular implants and extracorporeal systems.
Any feedback or questions on this document should be directed to the user’s national standards body. Acomplete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2019 – All rights reserved iii
---------------------- Page: 3 ----------------------
Cardiovascular implants and extracorporeal systems —
Cardiopulmonary bypass systems — Venous bubble traps
AMENDMENT 1: Connectors
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectorsfor intravascular or hypodermic applications
Replace the text with the following:
Connectors for connection to the blood pathway shall, when tested in accordance with 5.3.3, allow asecure 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 havebeen 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 thereference fittings given in Annex A.
Add the following annex before the Bibliography:
© ISO 2019 – All rights reserved 1
---------------------- Page: 4 ----------------------
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 ----------------------
Table A.1 — Dimensions of 6 % (Luer) conical fittings
Dimensions, in mm
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
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
Tolerance for length of engagement of the female
M 0,750 0,750
Tolerance for length of engagement of the male
N 1,083 1,700
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 requirementsspecified 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