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Catheter systems for neuraxial application. Sterile and single-use catheters and accessories

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Description

Catheter systems for neuraxial application. Sterile and single-use catheters and accessories1 Scope This document specifies general requirements and test methods for catheter systems intended to be used in neuraxial applications. This document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate conformity with these requirements. Catheters for neuraxial applications are intended to

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Gas-tight suit test personnel/testing laboratory

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on mounting surfaces

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and managed

comprising Latin alphanumeric and special graphic characters

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