EN ISO 80369-7 has just been released. It’s the European adoption of the ISO 80369-7. The title is Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications. This EN edition replaces the EN 1707 and the EN 20594-1. You can get your copy in a variety of national editions now from Document Center Inc.
The European edition has the unique feature of mandating the use of EN adoptions of all ISO or IEC standards referenced in the ISO 80369-7. Other than that, the text of the ISO 80369-7 from 2016 has been adopted without any further modifications. However, you will also find an Annex ZA in the document. This provides you with a relationship table for the standard and the Directive 93/42/EEC (the Medical Device Directive). The table goes through the essential requirements of the directive item by item and shows you the clauses of EN ISO 80369-7 that fulfill the requirement. Notes for each item are included.
The EN ISO 80369-7, like the ISO 80369-7, provides you with dimensions and requirements used in design and performance for small-bore connectors used in intravascular applications or hypodermic connections for medical devices and accessories. The document was developed to address the problems arising when connectors for multiple applications are the same. Now these particular small-bore connectors will only “mate” with others of their own kind. They will not be able to mis-connect with other small-bore connectors with other functionalities.
The standard is arranged in the usual fashion, with scope, referenced documents, and definitions provided in the first 3 clauses. General requirements are then given. Section 5 addresses the dimensional requirements for luer connectors. The body of the standard is completed with Clause 6 for performance requirements.
A series of both informative and normative Annexes then follows. These cover the rationale and guidance for the standard, luer connectors, reference connectors, and the types of medical devices with connections that are covered by the publication. Annex E gives you a summary of the usability requirements for these luer connectors. Annex F is a summary of the design requirements. And Annex G summarizes the assessment of the design of the connectors.
Annex H is interesting. It is a table with the correspondence of the essential principles set forth in ISO 16142-1 and the clauses or ISO 80369-7. Annex I is an alphabetical list of the defined terms which references the source ISO standard where the terminology originates. A 29-item bibliography completes this document.
When working with EN standards, it is important to note that they are only publicly available in national editions. And you’ll have many of them to choose from! Here is a listing of some that you can purchase from Document Center Inc. – EN ISO 80369-7 Standards List. The list will grow as additional publications are made available.
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