ISO 80369-7:2016 Foreword
ISO 80369-7 cancels and replaces the first edition ISO 594-1:1986 and the second edition of ISO 594-2:1998, clauses, subclauses, tables, figures, and annexes of which have been consolidated and technically revised. Changes...
ISO 80369-7:2021 Foreword
This second edition cancels and replaces the first edition (ISO 80369-7:2016), which has been technically revised. Changes...
ISO 80369-7 Introduction
ISO 80369-7 specifies the design and the dimensions and the drawings of small-bore connectors intended to be used as conical fittings with a 6 % (Luer) taper for connections in intravascular or hypodermic applications. ... Other parts of ISO 80369 include requirements for small-bore connectors used in different application categories. Connectors manufactured to the dimensions set out within this document are dimensionally incompatible with any of the other connectors for applications identified in the ISO 80369 series of documents for small-bore connectors, except as indicated in Annex G. If fitted to the relevant medical devices and accessories, these connectors should reduce the risk of air, non-vascular medication and liquid nutritional formula being delivered through an alternative route, such as intravenously or through an airway device.
ISO 80369-7 Scope
ISO 80369-7 specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.
ISO 80369-7 does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories. This document does not specify requirements for the following small-bore connectors, which are specified in other documents:
— haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and applicable portion of ISO 8638 referencing blood compartment ports);
— haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637);
— infusion system closure piercing connectors (ISO 8536-4).
ISO 80369-7 Conical Gauges
We offer extra-specification ISO 80369-7 Gages for in-process testing and incoming materials validation.
ISO 80369-7 Reference Connectors
ISO 80369-7 Annex C specifies the Reference Connectors to be used to functionally test Annex B Connectors.
We offer ISO 80369-7 Annex C Reference Connectors for sale which can be used for functional testing.
ISO 80369-7 Test Methodology
ISO 80369-7 Clause 6 defines the test requirements, and points to ISO 80369-20 where the test methodology is defined.
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This data is provided for general information only. The intention is to provide accurate information; regardless; errors may exist in the supplied information. If accuracy is critical, base your final decisions on the data provided in the root document: ISO80369-7:2016; which is a copyrighted document. To purchase a copy visit an Authorized Reseller.
Original Posting: 8/28/2014
Last Revision: 6/4/2021
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