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DIN EN ISO 23908:2026-01

Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods (ISO 23908:2024); German version EN ISO 23908:2025

Fecha edición: 2026-01-01
En Vigor
Idiomas disponibles: Alemán
Resumen: This document provides requirements and test methods to evaluate the performance and usability of sharps injury protection mechanisms (SIPMs) of devices including a single use sharp, for administration and/or extraction of blood or body fluids and/or medicinal substances. The sharps injury protection mechanisms covered by this document can be provided integral to the device or for assembly with the device prior to use. No requirements are given for the storage and handling of the protective device prior to its intended use or for the medical device itself.

Keywords: Blood taking|Blood-taking set|Cannulas|Catheters|Data of the manufacturer|Definitions|Equipment for single use|Health protection|Infusions|Injections|Injuries|Instructions for use|Marking|Medical devices|Medical equipment|Medical instruments|Medical products|Medical sciences|Needles|Protection against piercing|Protection devices|Protective caps|Protective measures|Public health|Safety device|Sections|Specification (approval)|Stitches|Surgical needles|Testing
ICS: 11.040.25 - Jeringuillas, agujas y catéteres
CTN:

Equivalencia Internacional

Idéntica EN ISO 23908:2025

Idéntica ISO 23908:2024

Reemplazo Normas

Reemplaza a DIN EN ISO 23908:2013-10

Reemplaza a DIN EN ISO 23908:2023-11

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