DIN Standards Committee Health Technologies
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 23908:2011
Schutz vor Stich- und Schnittverletzung - Anforderungen und Prüfverfahren - Schutzeinrichtungen für einmalig zu verwendende Nadeln zur subkutanen Injektion, Kathetereinführungen und Nadeln zur Blutentnahme (ISO 23908:2011); Deutsche Fassung EN ISO 23908:2011
Overview
This International Standard gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether 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 it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection. It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself. This document 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" (secretariat: DIN) with the participation of German experts. At DIN, the German Institute for Standardization e. V., the responsible Committee is Working Committee NA 063-02-01 AA "Injektionssysteme" ("Injection systems") of the Medical Standards Committee (NAMed).
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-04-02 AA - Injection systems
