2. Getting involved
3. Standards Committees
4. DKE

DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE

Overview

The standard specifies requirements and test methods for evaluating the performance parameters of sharps injury protection features. They can be active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling. The sharps injury protection devices this standard covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection. Furthermore, it is intended to prepare a Part 2 which shall provide specifications for the accessories for the handling of hypodermic needles after their usage. In Annex ZA, the new edition of DIN EN ISO 23908 covers the current provisions of the EU commission regarding the content and structure of Table ZA.1. This standard has been prepared by Technical Committee ISO/TC 84 "Devices for administration of medicinal products and intravascular catheters" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" and with the participation of German experts. The responsible committee at DIN, the German Institute for Standardization e. V., is Working Committee NA 063-02-01 AA "Injektionssysteme" ("Injection systems") at the Medicine Standards Committee (NAMed).

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-04-02 AA - Injection systems  

Responsible european committee

CEN/TC 205 - Non-active medical devices