What is EN ISO 7864:2016?

EN ISO 7864:2016 is an international standard that provides specifications for sterile hypodermic needles and syringes used in medical applications. This standard outlines the requirements and test methods for these medical devices, ensuring their safety and performance.

Relevant Terminology

In order to better understand EN ISO 7864:2016, it is important to familiarize ourselves with some of the key terminology used in this standard.

The standard defines a hypodermic needle as a hollow pointed cylindrical device, made of metal or other suitable materials, which is used with a syringe for the penetration of tissues and injection of fluids.

A syringe, on the other hand, is defined as a calibrated hollow barrel with a plunger and needle attachment. The barrel is used for containing and delivering fluids or medication to patients either by aspiration or injection.

Requirements outlined in EN ISO 7864:2016

The standard covers various requirements related to the design, materials, dimensions, performance, packaging, and labeling of hypodermic needles and syringes.

Design and dimensions: EN ISO 7864:2016 specifies the different types of needles, including their lengths, point geometries, and bevel angles. It also outlines the requirements for needle hubs, such as their shape, dimensions, and compatibility with syringes.

Materials: The standard provides guidelines on the suitable materials that can be used for manufacturing hypodermic needles and syringes. These materials must meet specific biocompatibility and sterility requirements.

Performance: The standard sets criteria for factors like needle sharpness, needle strength, and syringe functionality. It also includes specifications for features like needle caps, which must be securely fitted to prevent needlestick injuries.

Testing procedures

EN ISO 7864:2016 establishes various test methods to assess the quality and safety of hypodermic needles and syringes. These tests cover aspects such as needle penetration force, liquid leakage, needle tip sharpness, and resistance to breakage.

The standard also includes tests to evaluate aspects like the integrity of the packaging, sterilization process validation, and the legibility and durability of labeling on the product.

Overall, EN ISO 7864:2016 ensures that hypodermic needles and syringes meet stringent quality standards, promoting patient safety and effective medical practices.