ISO 18250-7:2018
(Main)Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion
This document specifies the interface dimensions and requirements for the design and functional performance of connectors intended to be used to connect intravascular infusion sets to intravascular infusion reservoirs. This document does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular international standards for specific medical devices or accessories. EXAMPLES Medical devices which may use intravascular reservoir connectors are the following: — Administration ports on IV fluid reservoirs and the mating spikes of IV administration/intravascular infusion sets/lines, e.g., IV bags/containers and the spike inlet ends of IV sets; — Devices intended to be connected in series between the administration port of IV fluid reservoirs and the mating spikes of IV administration/giving lines; — Syringes and syringe IV sets utilizing Luer connectors. The following connectors are excluded from the scope of this document: — Stoppers for bottles as specified in ISO 8536-2; — Compounding/admixture ports on IV reservoirs and intended mating devices. EXAMPLES Rubber stoppers used for injection into the reservoir and the mating pharmacy admixture devices (syringes, needles, reconstitution devices, and other ancillary equipment used to access the compounding or admixture ports). — The fill ports of non-powered (i.e. elastomeric) pumps. NOTE 1 Details of alternative spikes that are in common use are located in Annex G for informational purposes. NOTE 2 Manufacturers are encouraged to incorporate the connectors specified in this document into intravascular infusion medical devices or accessories, even if not currently required by the particular medical device standards. It is expected that when the particular medical device standards are revised, requirements for reservoir connectors, as specified in ISO 18250, will be included.
Dispositifs médicaux — Connecteurs pour systèmes de livraison de réservoir pour des applications de soins de santé — Partie 7: Connecteurs pour perfusion intravasculaire
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INTERNATIONAL ISO
STANDARD 18250-7
First edition
2018-12
Medical devices — Connectors
for reservoir delivery systems for
healthcare applications —
Part 7:
Connectors for intravascular infusion
Dispositifs médicaux — Connecteurs pour systèmes de livraison de
réservoir pour des applications de soins de santé —
Partie 7: Connecteurs pour perfusion intravasculaire
Reference number
©
ISO 2018
© ISO 2018
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 2018 – All rights reserved
Contents Page
Foreword .iv
Introduction .vi
1 *Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 2
4.1 Non-interconnectability through conformance to this document . 2
4.2 * Intravascular Reservoir Connector types . 2
5 Material requirements . 3
5.1 Connector Type 1: spikes and administration ports . 3
5.2 Connector Type 2: Luers . 3
6 Dimensional requirements . 3
6.1 Connector Type 1: Spikes and Administration Ports. 3
6.2 Connector Type 2: Luers . 3
7 Performance requirements . 3
7.1 * Connector Type 1: Spikes and Administration Ports . 3
7.2 Connector Type 2: Luers . 3
Annex A (informative) Rationale and guidance . 4
Annex B (normative) Design of connectors* .13
Annex C (informative) Assessment of reservoir connectors and their attributes with
connections to medical devices within this intravascular application .15
Annex D (informative) Summary of usability and requirements for connectors for
intravascular reservoirs .16
Annex E (informative) Summary of reservoir connector design requirements for
intravascular infusion .19
Annex F (informative) Summary of engineering analysis and residual misconnections for
connectors for intravascular reservoirs .24
Annex G (informative) Alternative spikes .30
Bibliography .34
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. 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. 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 on 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 WTO
principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary
information
This document was prepared by Technical Committee ISO/TC 210, Quality management and
corresponding general aspects for medical devices.
A list of all the 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: in smaller
type. Normative text of tables is also in smaller type.
— Terms defined in standard or as noted: small capitals.
— 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 Annex H of the ISO/IEC Directives,
Part 2. 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, and
— “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 2018 – 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 standard for enteral small-bore connectors (ISO 80369-3), it became
clear that the risk of misconnections was not limited to the patient access connectors and that the
whole enteral system needed to be considered. The possible misconnection between enteral feed
reservoir access connectors and the spikes typically used on intravenous administration sets was
also reviewed. However, as feed reservoir connectors are not exactly within the definition of small-
bore connectors, it was decided to develop a separate standard (ISO 18250-3) for these connectors,
taking into account the risks of misconnections with other devices such as intravenous (IV) bags.
During the development of ISO 18250-3, it became apparent that the ubiquitous intravenous spike was
specified in various ISO medical device standards but that the geometry and materials requirements
for the female port on the intravenous reservoir were not defined. However, the performance of this
female port was defined in various ISO standards.
This document, therefore, specifies the design, dimensions and materials for the female port. It makes
reference to existing performance standards. It also includes tests to validate that the spike and the
female port do not interconnect with the other reservoir connectors of the ISO 18250 series.
This document also includes analysis sufficient to include traditional Luer connectors of ISO 80369-7
as permissible reservoir connectors for intravascular applications.
This document is not a device standard as it specifies only the requirements of the interfaces for
connectors used in intravascular reservoirs and intravascular infusion sets.
vi © ISO 2018 – All rights reserved
INTERNATIONAL STANDARD ISO 18250-7:2018(E)
Medical devices — Connectors for reservoir delivery
systems for healthcare applications —
Part 7:
Connectors for intravascular infusion
1 *Scope
This document specifies the interface dimensions and requirements for the design and functional
performance of connectors intended to be used to connect intravascular infusion sets to
intravascular infusion reservoirs.
This document does not specify the dimensions and requirements for the medical devices or
accessories that use these connectors. Such requirements are given in particular international
standards for specific medical devices or accessories.
EXAMPLES Medical devices which may use intravascular reservoir connectors are the following:
— Administration ports on IV fluid reservoirs and the mating spikes of IV administration/intravascular
infusion sets/lines, e.g., IV bags/containers and the spike inlet ends of IV sets;
— Devices intended to be connected in series between the administration port of IV fluid reservoirs and the
mating spikes of IV administration/giving lines;
— Syringes and syringe IV sets utilizing Luer connectors.
The following connectors are excluded from the scope of this document:
— Stoppers for bottles as specified in ISO 8536-2;
— Compounding/admixture ports on IV reservoirs and intended mating devices.
EXAMPLES Rubber stoppers used for injection into the reservoir and the mating pharmacy admixture
devices (syringes, needles, reconstitution devices, and other ancillary equipment used to access the
compounding or admixture ports).
— The fill ports of non-powered (i.e. elastomeric) pumps.
NOTE 1 Details of alternative spikes that are in common use are located in Annex G for informational purposes.
NOTE 2 Manufacturers are encouraged to incorporate the connectors specified in this document into
intravascular infusion medical devices or accessories, even if not currently required by the particular
medical device standards. It is expected that when the particular medical device standards are revised,
requirements for reservoir connectors, as specified in ISO 18250, will be included.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1135-4, Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
ISO 3826 (all parts), Plastics collapsible containers for human blood and blood components
1)
ISO 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 15747, Plastic containers for intravenous injections
ISO 15759, Medical infusion equipment — Plastics caps with inserted elastomeric liner for containers
manufactured by the blo
...
INTERNATIONAL ISO
STANDARD 18250-7
First edition
2018-12
Medical devices — Connectors
for reservoir delivery systems for
healthcare applications —
Part 7:
Connectors for intravascular infusion
Dispositifs médicaux — Connecteurs pour systèmes de livraison de
réservoir pour des applications de soins de santé —
Partie 7: Connecteurs pour perfusion intravasculaire
Reference number
©
ISO 2018
© ISO 2018
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 2018 – All rights reserved
Contents Page
Foreword .iv
Introduction .vi
1 *Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 2
4.1 Non-interconnectability through conformance to this document . 2
4.2 * Intravascular Reservoir Connector types . 2
5 Material requirements . 3
5.1 Connector Type 1: spikes and administration ports . 3
5.2 Connector Type 2: Luers . 3
6 Dimensional requirements . 3
6.1 Connector Type 1: Spikes and Administration Ports. 3
6.2 Connector Type 2: Luers . 3
7 Performance requirements . 3
7.1 * Connector Type 1: Spikes and Administration Ports . 3
7.2 Connector Type 2: Luers . 3
Annex A (informative) Rationale and guidance . 4
Annex B (normative) Design of connectors* .13
Annex C (informative) Assessment of reservoir connectors and their attributes with
connections to medical devices within this intravascular application .15
Annex D (informative) Summary of usability and requirements for connectors for
intravascular reservoirs .16
Annex E (informative) Summary of reservoir connector design requirements for
intravascular infusion .19
Annex F (informative) Summary of engineering analysis and residual misconnections for
connectors for intravascular reservoirs .24
Annex G (informative) Alternative spikes .30
Bibliography .34
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. 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. 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 on 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 WTO
principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary
information
This document was prepared by Technical Committee ISO/TC 210, Quality management and
corresponding general aspects for medical devices.
A list of all the 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: in smaller
type. Normative text of tables is also in smaller type.
— Terms defined in standard or as noted: small capitals.
— 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 Annex H of the ISO/IEC Directives,
Part 2. 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, and
— “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 2018 – 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 standard for enteral small-bore connectors (ISO 80369-3), it became
clear that the risk of misconnections was not limited to the patient access connectors and that the
whole enteral system needed to be considered. The possible misconnection between enteral feed
reservoir access connectors and the spikes typically used on intravenous administration sets was
also reviewed. However, as feed reservoir connectors are not exactly within the definition of small-
bore connectors, it was decided to develop a separate standard (ISO 18250-3) for these connectors,
taking into account the risks of misconnections with other devices such as intravenous (IV) bags.
During the development of ISO 18250-3, it became apparent that the ubiquitous intravenous spike was
specified in various ISO medical device standards but that the geometry and materials requirements
for the female port on the intravenous reservoir were not defined. However, the performance of this
female port was defined in various ISO standards.
This document, therefore, specifies the design, dimensions and materials for the female port. It makes
reference to existing performance standards. It also includes tests to validate that the spike and the
female port do not interconnect with the other reservoir connectors of the ISO 18250 series.
This document also includes analysis sufficient to include traditional Luer connectors of ISO 80369-7
as permissible reservoir connectors for intravascular applications.
This document is not a device standard as it specifies only the requirements of the interfaces for
connectors used in intravascular reservoirs and intravascular infusion sets.
vi © ISO 2018 – All rights reserved
INTERNATIONAL STANDARD ISO 18250-7:2018(E)
Medical devices — Connectors for reservoir delivery
systems for healthcare applications —
Part 7:
Connectors for intravascular infusion
1 *Scope
This document specifies the interface dimensions and requirements for the design and functional
performance of connectors intended to be used to connect intravascular infusion sets to
intravascular infusion reservoirs.
This document does not specify the dimensions and requirements for the medical devices or
accessories that use these connectors. Such requirements are given in particular international
standards for specific medical devices or accessories.
EXAMPLES Medical devices which may use intravascular reservoir connectors are the following:
— Administration ports on IV fluid reservoirs and the mating spikes of IV administration/intravascular
infusion sets/lines, e.g., IV bags/containers and the spike inlet ends of IV sets;
— Devices intended to be connected in series between the administration port of IV fluid reservoirs and the
mating spikes of IV administration/giving lines;
— Syringes and syringe IV sets utilizing Luer connectors.
The following connectors are excluded from the scope of this document:
— Stoppers for bottles as specified in ISO 8536-2;
— Compounding/admixture ports on IV reservoirs and intended mating devices.
EXAMPLES Rubber stoppers used for injection into the reservoir and the mating pharmacy admixture
devices (syringes, needles, reconstitution devices, and other ancillary equipment used to access the
compounding or admixture ports).
— The fill ports of non-powered (i.e. elastomeric) pumps.
NOTE 1 Details of alternative spikes that are in common use are located in Annex G for informational purposes.
NOTE 2 Manufacturers are encouraged to incorporate the connectors specified in this document into
intravascular infusion medical devices or accessories, even if not currently required by the particular
medical device standards. It is expected that when the particular medical device standards are revised,
requirements for reservoir connectors, as specified in ISO 18250, will be included.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1135-4, Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
ISO 3826 (all parts), Plastics collapsible containers for human blood and blood components
1)
ISO 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 15747, Plastic containers for intravenous injections
ISO 15759, Medical infusion equipment — Plastics caps with inserted elastomeric liner for containers
manufactured by the blo
...
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