ISO 18250-6:2019
(Main)Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applications
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applications
This document specifies the connectors recommended for the outlet ports of neural reservoirs and inlet ports of neural giving sets.
Dispositifs médicaux — Connecteurs pour systèmes de livraison de réservoir pour des applications de soins de santé — Partie 6: Applications neurales
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INTERNATIONAL ISO
STANDARD 18250-6
First edition
2019-03
Medical devices — Connectors
for reservoir delivery systems for
healthcare applications —
Part 6:
Neural applications
Dispositifs médicaux — Connecteurs pour systèmes de livraison de
réservoir pour des applications de soins de santé —
Partie 6: Applications neurales
Reference number
©
ISO 2019
© 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 address
below 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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
Contents Page
Foreword .iv
Introduction .vi
1 *Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 *Neural reservoir outlet port connector. 1
5 *Neural giving set inlet port connector . 1
Annex A (informative) Rationale . 2
Annex B (informative) Summary of design history of connectors for neural reservoirs .3
Bibliography . 6
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
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 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).
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/or
on 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 not
constitute 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 210, Quality management and
corresponding general aspects for medical devices.
A list of all parts in the ISO 18250 series can be found on the ISO website.
In this document, the following print types are used:
— requirements and definitions: roman type;
— informative material appearing outside of tables, such as notes, examples and references:
smaller type;
— terms defined in this document: small caps;
— compliance requirements: italic type.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in the ISO/IEC Directives, Part 2,
Annex H. For the purposes of this document, the auxiliary verb:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
document;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this document;
— “may” is used to describe a permissible way to achieve compliance with a requirement or test;
— An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
iv © ISO 2019 – All rights reserved
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.
Introduction
During the development of the ISO 80369 series of standards for small-bore connectors for liquids and
gases in healthcare applications it became evident that the risk of misconnections was not limited to the
patient access connectors and that the connectors used at the reservoir end of the systems were also
a potential high risk for misconnection. For many reasons these reservoir connectors did not fit well
within the scope of ISO 80369 so it was decided to develop a separate series of standards specifically for
these reservoir connectors. The 18250 series takes into account the risks of misconnections between
the reservoir connectors of different applications including the existing standardized IV spike specified
in ISO 8536-4 and ISO 1135-4.
NOTE Manufacturers are encouraged to incorporate the connectors specified in this document into medical
devices, even if not currently required by the particular device standard. It is expected that when the particular
device standards are revised, requirements for connectors with the dimensions, as specified within this
document, will be included.
vi © ISO 2019 – All rights reserved
INTERNATIONAL STANDARD ISO 18250-6:2019(E)
Medical devices — Connectors for reservoir delivery
systems for healthcare applications —
Part 6:
Neural applications
1 *Scope
This document specifies the connectors recommended for the outlet ports
...
INTERNATIONAL ISO
STANDARD 18250-6
First edition
2019-03
Medical devices — Connectors
for reservoir delivery systems for
healthcare applications —
Part 6:
Neural applications
Dispositifs médicaux — Connecteurs pour systèmes de livraison de
réservoir pour des applications de soins de santé —
Partie 6: Applications neurales
Reference number
©
ISO 2019
© 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 address
below 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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
Contents Page
Foreword .iv
Introduction .vi
1 *Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 *Neural reservoir outlet port connector. 1
5 *Neural giving set inlet port connector . 1
Annex A (informative) Rationale . 2
Annex B (informative) Summary of design history of connectors for neural reservoirs .3
Bibliography . 6
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
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 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).
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/or
on 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 not
constitute 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 210, Quality management and
corresponding general aspects for medical devices.
A list of all parts in the ISO 18250 series can be found on the ISO website.
In this document, the following print types are used:
— requirements and definitions: roman type;
— informative material appearing outside of tables, such as notes, examples and references:
smaller type;
— terms defined in this document: small caps;
— compliance requirements: italic type.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in the ISO/IEC Directives, Part 2,
Annex H. For the purposes of this document, the auxiliary verb:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
document;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this document;
— “may” is used to describe a permissible way to achieve compliance with a requirement or test;
— An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
iv © ISO 2019 – All rights reserved
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.
Introduction
During the development of the ISO 80369 series of standards for small-bore connectors for liquids and
gases in healthcare applications it became evident that the risk of misconnections was not limited to the
patient access connectors and that the connectors used at the reservoir end of the systems were also
a potential high risk for misconnection. For many reasons these reservoir connectors did not fit well
within the scope of ISO 80369 so it was decided to develop a separate series of standards specifically for
these reservoir connectors. The 18250 series takes into account the risks of misconnections between
the reservoir connectors of different applications including the existing standardized IV spike specified
in ISO 8536-4 and ISO 1135-4.
NOTE Manufacturers are encouraged to incorporate the connectors specified in this document into medical
devices, even if not currently required by the particular device standard. It is expected that when the particular
device standards are revised, requirements for connectors with the dimensions, as specified within this
document, will be included.
vi © ISO 2019 – All rights reserved
INTERNATIONAL STANDARD ISO 18250-6:2019(E)
Medical devices — Connectors for reservoir delivery
systems for healthcare applications —
Part 6:
Neural applications
1 *Scope
This document specifies the connectors recommended for the outlet ports
...
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