🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS EN ISO 80369-6:2016:2017 Edition

BS EN ISO 80369-6:2016:2017 Edition

$198.66

Small bore connectors for liquids and gases in healthcare applications – Connectors for neuraxial applications

Published By Publication Date Number of Pages
BSI 2017 60
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

This part of ISO 80369 specifies requirements for small-bore connectors intended to be used for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.

NOTE 1 Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain, and the epi-, extra-, or peri-dural space. Neuraxial application anaesthetics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents.

NOTE 2 For the purposes of this part of ISO 80369, local anaesthesia injected hypodermically is not considered a neuraxial application.

EXAMPLES Intended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, antibiotics, analgesics.

This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of these small-bore connectors intended to be used with medical devices.

This part of ISO 80369 does not specify 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.

NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 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 small-bore connectors, as specified in this part of ISO 80369, will be included. Furthermore, it is recognized that standards need to be developed for many medical devices used for neuraxial applications.

NOTE 4 ISO 80369-1:2010, 5.8, specifies alternative methods of compliance with ISO 80369-1:2010, for small-bore connectors intended for use with neuraxial application medical devices or accessories, which do not comply with this part of ISO 80369.

PDF Catalog

PDF Pages PDF Title
4 European foreword
5 Table — Correlation between normative references and dated EN and ISO standards
Endorsement notice
6 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC
Table ZA.1 — Correspondence between this document and Directive 93/42/EEC
7 Table ZA.2 — Relevant Essential Health and Safety Requirements (EHSRs) from Directive 2006/42/EC on machinery that are addressed by this document
9 Foreword
10 Introduction
13 1 * Scope
2 Normative references
14 3 Terms and definitions
15 4 General requirements
4.1 General requirements for the neuraxial application
16 4.2 * Material used for small-bore connectors
4.3 ​Type tests
5 Dimensional requirements for neuraxial small-bore connectors
6 Performance requirements
6.1 Fluid leakage
6.1.1 Fluid leakage requirement
6.1.2 Leakage by pressure decay
6.1.3 Positive pressure liquid leakage
17 6.2 Subatmospheric pressure air leakage
6.3 Stress cracking
6.4 Resistance to separation from axial load
6.5 Resistance to separation from unscrewing
6.6 Resistance to overriding
18 Annex A (informative) Rationale and guidance
23 Annex B (normative) * Small-bore connectors for neuraxial applications
32 Annex C (normative) Reference connectors for testing small-bore connectors for neuraxial applications
38 Annex D (informative) Assessment of medical devices and their attributes with connections within this application
39 Annex E (informative) Summary of the usability requirements for small-bore connectors for neuraxial applications
42 Annex F (informative) Summary of small-bore connector design requirements for neuraxial applications
45 Annex G (informative) Summary of assessment of the design of the small bore connectors for neuraxial applications
49 Annex H (normative) Mechanical tests for verifying non-interconnectable characteristics
53 Annex I (informative) Reference to the essential principles
55 Annex J (informative) Terminology — alphabetized index of defined terms
56 Bibliography

Related products

BS EN ISO 80369-6:2016
$198.66