BS EN ISO 80369-6:2016

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Dimensional requirements for neuraxial SMALL-BORE
  CONNECTORS
6 Performance requirements
Annex A (informative) - Rationale and guidance
Annex B (normative) - SMALL-BORE CONNECTORS for neuraxial
        APPLICATIONS
Annex C (normative) - Reference CONNECTORS for testing
        SMALL-BORE CONNECTORS for neuraxial APPLICATIONS
Annex D (informative) - Assessment of MEDICAL DEVICES
        and their attributes with CONNECTIONS within this
        APPLICATION
Annex E (informative) - Summary of the usability requirements
        for SMALL-BORE CONNECTORS for neuraxial APPLICATIONS
Annex F (informative) - Summary of SMALL-BORE CONNECTOR
        design requirements for neuraxial APPLICATIONS
Annex G (informative) - Summary of assessment of the design
        of the SMALL BORE CONNECTORS for neuraxial
        APPLICATIONS
Annex H (normative) - Mechanical tests for verifying
        NON-INTERCONNECTABLE characteristics
Annex I (informative) - Reference to the essential principles
Annex J (informative) - Terminology - alphabetized index
        of defined terms
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC

Defines requirements for SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in neuraxial APPLICATIONS.

This part of ISO80369 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. NOTE1 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. NOTE2 For the purposes of this part of ISO80369, 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 ISO80369 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 ISO80369 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. NOTE3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO80369 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 ISO80369, will be included. Furthermore, it is recognized that standards need to be developed for many medical devices used for neuraxial applications. NOTE4 ISO80369-1:2010, 5.8, specifies alternative methods of compliance with ISO80369-1:2010, for small-bore connectors intended for use with neuraxial application medical devices or accessories, which do not comply with this part of ISO80369.