ISO 18250-1:2018
(Main)Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods
This document specifies general requirements for reservoir connectors, which convey fluids in healthcare applications. These reservoir connectors are used in medical devices or accessories intended for use with a patient. This document also specifies the healthcare fields in which these reservoir connectors are intended to be used. These healthcare fields of use include, but are not limited to, applications for — respiratory, — enteral, — neural, — intravascular, — citrate-based anticoagulant solution, and — irrigation. Reservoir connectors as specified in this document are non-interconnectable with: — the reservoir connectors of every other application specified in the ISO 18250 series; — removable temperature sensor port specified in Annex EE of ISO 80601-2-74:2017; — the nipples specified in Annex B of ISO 17256[1]; unless otherwise specified in the ISO 18250 series. Application parts of the ISO 18250 series can specify additional connectors with which reservoir connectors (as specified in those application parts) are to be non-interconnectable. This document provides the methodology to assess non-interconnectable characteristics of reservoir connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications. This document does not specify requirements for the medical devices or accessories that use these reservoir connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. NOTE 1 Manufacturers are encouraged to incorporate the reservoir connectors specified in the ISO 18250 series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for reservoir connectors as specified in the series of standards will be included. NOTE 2 The ISO 18250 series does not apply to screw and crown cork caps and necks as they are not connectors specific for medical devices. Examples of screw caps and necks are defined in DIN 55525, ASTM D2911/D2911M, DIN 6063-1, DIN 6063-2, DIN 168-1. Examples of crown cork caps and necks are defined in DIN 6094, ISO 12821, EN 14635. This document also specifies the test methods to verify the common performance requirements for reservoir connectors. The performance requirements for these common test methods are specified in the application parts and not in the general part. [1] Under preparation. Stage at the time of publication: ISO/DIS 17256:2017.
Dispositifs médicaux — Connecteurs pour systèmes de livraison de réservoir pour des applications de soins de santé — Partie 1: Exigences générales et méthodes d'essai courantes
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INTERNATIONAL ISO
STANDARD 18250-1
First edition
2018-12
Medical devices — Connectors
for reservoir delivery systems for
healthcare applications —
Part 1:
General requirements and common
test methods
Dispositifs médicaux — Connecteurs pour systèmes de livraison de
réservoir pour des applications de soins de santé —
Partie 1: Exigences générales et méthodes d'essai courantes
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 . 2
3 Terms and definitions . 2
4 Materials used for reservoir connectors . 4
4.1 *General . 4
4.2 Alternative test methods . 4
5 *Requirements for reservoir connectors for specific applications .4
5.1 *Reservoir connector incompatibility . 4
5.2 Enteral applications . 5
5.3 Neural applications . 5
5.4 Intravascular applications . 5
5.5 Citrate-based anticoagulant solution for apheresis applications . 5
6 *reservoir connectors for applications not already covered in the ISO 18250 series .5
7 *Performance requirements . 5
7.1 Leakage . 5
7.1.1 Positive-pressure liquid leakage . 5
7.1.2 Sub atmospheric pressure air leakage . 6
7.2 Stress-cracking . 6
7.3 Resistance to separation from axial load. 6
7.4 Resistance to separation from unscrewing . 6
7.5 Resistance to overriding . 6
7.6 Disconnection by unscrewing for floating or rotating screw-thread locking
connectors and locking connectors with fixed threads . 6
Annex A (informative) Rationale and guidance . 7
Annex B (normative) test methods for demonstrating non-interconnectable characteristics .14
Annex C (normative) *Positive pressure liquid leakage test method .28
Annex D (normative) *Sub-atmospheric-pressure air leakage test method .31
Annex E (normative) *Stress cracking test method .35
Annex F (normative) *Resistance to separation from axial load test method .37
Annex G (normative) *Resistance to separation from unscrewing test method .39
Annex H (normative) *Resistance to overriding test method .41
Annex I (normative) *Disconnection by unscrewing test method for floating or rotating
screw-thread locking connectors and locking connectors with fixed threads .43
Annex J (informative) *Modification of the test methods to generate variable data for
statistical analysis .45
Annex K (informative) Examples of medical devices on which reservoir connectors may
be used for each application category .48
Annex L (informative) Alternative mechanical test methods .49
Bibliography .50
Terminology — Alphabetical index of defined terms .52
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 the parts in the ISO 18250 series can be found on the ISO website. The numbering of the
parts follows in parallel the clinical applications listed in ISO 80369-1:2018 where applicable. Other
parts are expected to be added in the future for applications not yet covered.
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 a smaller type;
— compliance checks: italic type;
— Terms defined in this document or as noted: small capitals.
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.
For the purposes of this document, the following verbal forms are used:
— “shall” indicates that compliance with a requirement or a test is mandatory for compliance with this
document,
— “should” indicates 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 ISO 80369 series of standards for small-bore connectors, it became
evident that equally important were the connections between medical devices and fluid reservoirs.
It was agreed that such connectors should be developed in parallel with the small-bore connectors
specified in the ISO 80369 series of standards and comply with analogous safety and interoperability
requirements.
ISO 16142-1:2016, Clause 4 addresses this type of problem.
The solutions adopted by the manufacturer for the design and manufacture of the medical device
should conform to safety principles, taking into account the generally acknowledged state of the
art. When risk reduction is required, the manufacturer should control the risks so that the residual
risk associated with each hazard is judged acceptable. The manufacturer should apply the following
principles in the priority order listed:
a) identify known or foreseeable hazards and estimate the associated risks arising from the
intended use and foreseeable misuse;
b) eliminate risks as far as reasonably practicable through inherently safe design and manufacture;
c) reduce as far as reasonably practicable the remaining risks by taking adequate protection
measures, including alarms or information for safety;
d) inform users of any residual risk.
It was soon realized that many of the reservoirs that contain liquids for administering to patients for
different applications all utilized the same ubiquitous spike as the connector between the giving set
and the reservoir leading to wrong drug administration. The ISO 18250 series endeavours to provide
unique designs for each of the applications specified to reduce the risk of administering the wrong
drug. It is understood that reservoir connector systems cannot be designed to overcome all chances
of misconnection or to eliminate deliberate misuse. However, a number of steps that would improve the
current situation and lead to greater patient safety can be taken. This will only be achieved through
a long-term commitment involving industry, healthcare professionals, medical device purchasers and
medical device regulatory authorities.
The ISO 18250 series specifies the requirements to prevent misconnection between reservoir
connectors used in different applications. This document specifies the general requirements and
test methods common to all reservoir connectors in this series. Test methods that are specific
to a particular reservoir connector will be included in that application part. The ISO 18250 series
specifies the requirements to prevent misconnections or reduce their occurrence to acceptable levels
between reservoir connectors used in different applications.
vi © ISO 2018 – All rights reserved
...
INTERNATIONAL ISO
STANDARD 18250-1
First edition
2018-12
Medical devices — Connectors
for reservoir delivery systems for
healthcare applications —
Part 1:
General requirements and common
test methods
Dispositifs médicaux — Connecteurs pour systèmes de livraison de
réservoir pour des applications de soins de santé —
Partie 1: Exigences générales et méthodes d'essai courantes
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 . 2
3 Terms and definitions . 2
4 Materials used for reservoir connectors . 4
4.1 *General . 4
4.2 Alternative test methods . 4
5 *Requirements for reservoir connectors for specific applications .4
5.1 *Reservoir connector incompatibility . 4
5.2 Enteral applications . 5
5.3 Neural applications . 5
5.4 Intravascular applications . 5
5.5 Citrate-based anticoagulant solution for apheresis applications . 5
6 *reservoir connectors for applications not already covered in the ISO 18250 series .5
7 *Performance requirements . 5
7.1 Leakage . 5
7.1.1 Positive-pressure liquid leakage . 5
7.1.2 Sub atmospheric pressure air leakage . 6
7.2 Stress-cracking . 6
7.3 Resistance to separation from axial load. 6
7.4 Resistance to separation from unscrewing . 6
7.5 Resistance to overriding . 6
7.6 Disconnection by unscrewing for floating or rotating screw-thread locking
connectors and locking connectors with fixed threads . 6
Annex A (informative) Rationale and guidance . 7
Annex B (normative) test methods for demonstrating non-interconnectable characteristics .14
Annex C (normative) *Positive pressure liquid leakage test method .28
Annex D (normative) *Sub-atmospheric-pressure air leakage test method .31
Annex E (normative) *Stress cracking test method .35
Annex F (normative) *Resistance to separation from axial load test method .37
Annex G (normative) *Resistance to separation from unscrewing test method .39
Annex H (normative) *Resistance to overriding test method .41
Annex I (normative) *Disconnection by unscrewing test method for floating or rotating
screw-thread locking connectors and locking connectors with fixed threads .43
Annex J (informative) *Modification of the test methods to generate variable data for
statistical analysis .45
Annex K (informative) Examples of medical devices on which reservoir connectors may
be used for each application category .48
Annex L (informative) Alternative mechanical test methods .49
Bibliography .50
Terminology — Alphabetical index of defined terms .52
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 the parts in the ISO 18250 series can be found on the ISO website. The numbering of the
parts follows in parallel the clinical applications listed in ISO 80369-1:2018 where applicable. Other
parts are expected to be added in the future for applications not yet covered.
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 a smaller type;
— compliance checks: italic type;
— Terms defined in this document or as noted: small capitals.
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.
For the purposes of this document, the following verbal forms are used:
— “shall” indicates that compliance with a requirement or a test is mandatory for compliance with this
document,
— “should” indicates 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 ISO 80369 series of standards for small-bore connectors, it became
evident that equally important were the connections between medical devices and fluid reservoirs.
It was agreed that such connectors should be developed in parallel with the small-bore connectors
specified in the ISO 80369 series of standards and comply with analogous safety and interoperability
requirements.
ISO 16142-1:2016, Clause 4 addresses this type of problem.
The solutions adopted by the manufacturer for the design and manufacture of the medical device
should conform to safety principles, taking into account the generally acknowledged state of the
art. When risk reduction is required, the manufacturer should control the risks so that the residual
risk associated with each hazard is judged acceptable. The manufacturer should apply the following
principles in the priority order listed:
a) identify known or foreseeable hazards and estimate the associated risks arising from the
intended use and foreseeable misuse;
b) eliminate risks as far as reasonably practicable through inherently safe design and manufacture;
c) reduce as far as reasonably practicable the remaining risks by taking adequate protection
measures, including alarms or information for safety;
d) inform users of any residual risk.
It was soon realized that many of the reservoirs that contain liquids for administering to patients for
different applications all utilized the same ubiquitous spike as the connector between the giving set
and the reservoir leading to wrong drug administration. The ISO 18250 series endeavours to provide
unique designs for each of the applications specified to reduce the risk of administering the wrong
drug. It is understood that reservoir connector systems cannot be designed to overcome all chances
of misconnection or to eliminate deliberate misuse. However, a number of steps that would improve the
current situation and lead to greater patient safety can be taken. This will only be achieved through
a long-term commitment involving industry, healthcare professionals, medical device purchasers and
medical device regulatory authorities.
The ISO 18250 series specifies the requirements to prevent misconnection between reservoir
connectors used in different applications. This document specifies the general requirements and
test methods common to all reservoir connectors in this series. Test methods that are specific
to a particular reservoir connector will be included in that application part. The ISO 18250 series
specifies the requirements to prevent misconnections or reduce their occurrence to acceptable levels
between reservoir connectors used in different applications.
vi © ISO 2018 – All rights reserved
...
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