ISO 18250-8:2018
(Main)Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications
This document specifies dimensions and requirements for the design and functional performance of apheresis anticoagulant (AC) reservoir connectors. 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. The following examples of medical devices are intended to use the connectors of this document: — Apheresis tubing sets and mating reservoirs containing citrate-based anticoagulant solution. — Apheresis tubing sets may include, but are not limited to those for use in blood collection, therapeutic applications, and plasma collection. Some apheresis sets are manufactured with a pre-connected reservoir containing citrate-based anticoagulant solution. These medical devices are not intended to use the connectors of this document. NOTE Manufacturers are encouraged to incorporate the connectors specified in this document into apheresis 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 apheresis AC reservoir connectors, will be included.
Dispositifs médicaux — Connecteurs pour systèmes de livraison de réservoir pour des applications de soins de santé — Partie 8: Solution anticoagulante à base de citrate pour les applications d'aphérèse
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 18250-8
First edition
2018-08
Medical devices — Connectors
for reservoir delivery systems for
healthcare applications —
Part 8:
Citrate-based anticoagulant solution
for apheresis applications
Dispositifs médicaux — Connecteurs pour systèmes de livraison de
réservoir pour des applications de soins de santé —
Partie 8: Solution anticoagulante à base de citrate pour les
applications d'aphérèse
Reference number
©
ISO 2018
© ISO 2018
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ii © ISO 2018 – All rights reserved
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 Non-Interconnectability through conformance to ISO 18250-8 . 3
4.2 *Materials . 3
4.3 Apheresis AC reservoir connector Descriptions . 3
4.4 *Design . 4
4.5 Reference connectors . 4
5 Performance requirements . 4
5.1 General . 4
5.2 *Positive pressure liquid leakage. 4
5.3 Stress-cracking . 4
5.4 Resistance to separation from axial load. 4
5.5 Resistance to separation from unscrewing . 4
5.6 Resistance to overriding . 5
5.7 *Subatmospheric pressure air leakage . 5
Annex A (informative) Rationale and guidance . 6
Annex B (normative) connectors drawings and dimensions . 7
Annex C (normative) Reference connectors .10
Annex D (informative) Summary of assessment of the design of the apheresis AC reservoir
connectors .19
Bibliography .24
Foreword
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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
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Attention is drawn to the possibility that some of the elements of this document may be the subject of
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on the ISO list of patent declarations received (see www .iso .org/patents).
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.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: in
smaller type.
— Normative text of tables is also in a smaller type.
— Terms defined in this standard: small caps.
— Compliance requirements: italic type.
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combination of the conditions is true.
For the purposes of this document, the following verbal forms are used:
— “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 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 series of standards for small-bore connectors for liquids and gases in
healthcare applications (see ISO 80369) it became clear that the risk of misconnections was not limited
to the patient access connectors and that the whole reservoir system needed to be considered. The
possible misconnection between apheresis AC reservoir connectors and spikes was also reviewed.
However, as apheresis AC reservoir connectors are not exactly within the definition of small-
bore connectors it was decided to develop this separate standard for these connectors, taking into
account the risks of misconnections with other devices such as IV bags, and blood pressure cuffs that
are likely to be used on the same patient.
This document, therefore, defines the apheresis AC reservoir connectors in geometry, material,
and performance to permit them being analyzed (and avoided) by other connectors intended for non-
apheresis applications (i.e. the other application parts of the ISO 18250 series).
This document is not a device standard as it specifies only the dimensions of the interfaces for the
apheresis AC reservoir connectors used on the disposable tubing sets and solution reservoirs.
vi © ISO 2018 – All rights reserved
INTERNATIONAL STANDARD ISO 18250-8:2018(E)
Medical devices — Connectors for reservoir delivery
systems for healthcare applications —
Part 8:
Citrate-based anticoagulant solution for apheresis
applications
1 Scope
This document specifies dimensions and requirements for the design and functional performance of
apheresis anticoagulant (AC) reservoir connectors.
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.
The following examples of medical devices are intended to use the connectors of this document:
— Apheresis tubing sets and mating reservoirs containing citrate-based anticoagulant solution.
— Apheresis tubing sets may include, but are not limited to those for use in blood collection, therapeutic
applications, and plasma collection.
Some apheresis sets are manufactured with a pre-connected reservoir containing citrate-based
anticoagulant solution. These medical devices are not intended to use the connectors of this
document.
NOTE Manufacturers are encouraged to incorporate the connectors specified in this document into
apheresis 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 apheresis AC
reservoir connectors, 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.
1)
ISO 18250-1:— , Medical devices — Connectors for reservoir delivery systems for healthcare applications —
Part 1: General requirements and common test methods
ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications — Part 20:
Common test methods
3 Terms and definitions
3.1
accessory
additional part(s) for use with medical device (3.7) in order to:
— achieve the intended use,
1) Under preparation. Stage at the time of publication: ISO/FDIS 18250-1.
— adapt it to some special use,
— facilitate its use,
— enhance its performance, or
— enable its functions to be integrated with those of other medical devices (3.7)
2)
[SOURCE: ISO 80369-1:— , definition 3.1]
3.2
apheresis
procedure in which blood is drawn from a donor or patient and separated into its components, some of
which are retained and the remainder returned by transfusion to the donor or patient
3.3
apheresis anticoagulant reservoir connector
apheresis AC reservoir connector
connector (3.6) for citrate-based anticoagulant (3.4) solutions for apheresis (3.2) applications
3.4
citrate-based anticoagulant
citrate, in the form of sodium citrate or acid-citrate-dextrose, added to the blood as it is drawn from the
subject’s circulation which binds or chelates ionised calcium within the blood, impeding those steps of
the coagulation pathway that are dependent on the presence of ionised calcium
3.5
connection
union or joining of mating halves of a connector (3.6)
[SOURCE: ISO 80369-1:—, definition 3.4]
3.6
connector
mechanical device, consisting of one of two mating halves and designed to join a conduit to convey
liquids or gases
[SOURCE: ISO 80369-1:—, definition 3.5]
3.7
medical device
instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material or other similar or related article, intended by
...
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