EN ISO 23908 Sharp Point Injury Protection, Standard Test for Disposable Hypodermic Needles

EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 23908 standard. EN ISO 23908 gives requirements and test methods for the evaluation of performance parameters of sharps injury protection properties, whether active or passive in design, for disposable (sharp) hypodermic needles, introducers for catheters and scalpels, and medical devices containing other needles used.

The sharps injury protection devices it covers may be provided with or integrated into the instrument prior to use to protect against sharps injury.

It does not provide requirements for storage and transport of the cutting tool protection prior to its intended use or for the medical device itself.

This International standard provides guidelines to enable the manufacturer to verify that the design of cutting tool injury protection systems conforms to the design intent specified in the design specification. As part of this verification, the manufacturer is expected to demonstrate, using appropriate simulated or clinical use studies, that the performance of the blade injury protection system is appropriate for the intended users and settings.

These simulated or clinical use studies allow the manufacturer to demonstrate that the device functions as intended, when used in accordance with the instructions for use, at settings representative of real-life intended use and by intended or predictable users.

EUROLAB assists manufacturers with EN ISO 23908 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.