DIN EN ISO 23908
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011); German version EN ISO 23908:2013
Schutz vor Stich- und Schnittverletzung - Anforderungen und Prüfverfahren - Schutzeinrichtungen für einmalig zu verwendende Kanülen zur subkutanen Injektion, Kathetereinführungen und Kanülen zur Blutentnahme (ISO 23908:2011); Deutsche Fassung EN ISO 23908:2013
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
