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BS ISO 18250-1:2018

BS ISO 18250-1:2018

$198.66

Medical devices. Connectors for reservoir delivery systems for healthcare applications – General requirements and common test methods

Published By Publication Date Number of Pages
BSI 2018 62
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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 80601ā€‘2ā€‘74:2017;

  • the nipples specified in Annex B of ISO 172561;

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 6063ā€‘1, DIN 6063ā€‘2, DIN 168ā€‘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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
6 Foreword
8 Introduction
9 1 *Scope
10 2 Normative references
3 Terms and definitions
12 4 Materials used for reservoir connectors
4.1 *General
4.2 Alternative test methods
5 *Requirements for reservoir connectors for specific applications
5.1 *Reservoir connector incompatibility
13 5.2 Enteral applications
5.3 Neural applications
5.4 Intravascular applications
5.5 Citrate-based anticoagulant solution for apheresis applications
6 *reservoir connectors for applications not already covered in the ISO 18250 series
7 *Performance requirements
7.1 Leakage
7.1.1 Positive-pressure liquid leakage
14 7.1.2 Sub atmospheric pressure air leakage
7.2 Stress-cracking
7.3 Resistance to separation from axial load
7.4 Resistance to separation from unscrewing
7.5 Resistance to overriding
7.6 Disconnection by unscrewing for floating or rotating screwā€thread locking connectors and locking connectors with fixed threads
15 Annex A (informative) Rationale and guidance
22 Annex B (normative) test methods for demonstrating non-interconnectable characteristics
36 Annex C (normative) *Positive pressure liquid leakage test method
39 Annex D (normative) *Sub-atmospheric-pressure air leakage test method
43 Annex E (normative) *Stress cracking test method
45 Annex F (normative) *Resistance to separation from axial load test method
47 Annex G (normative) *Resistance to separation from unscrewing test method
49 Annex H (normative) *Resistance to overriding test method
51 Annex I (normative) *Disconnection by unscrewing test method for floating or rotating screw-thread locking connectors and locking connectors with fixed threads
53 Annex J (informative) *Modification of the test methods to generate variable data for statistical analysis
56 Annex K (informative) Examples of medical devices on which reservoir connectors may be used for each application category
57 Annex L (informative) Alternative mechanical test methods
58 Bibliography
59 Terminology ā€” Alphabetical index of defined terms

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BS ISO 18250-1:2018
$198.66