UNE EN ISO 11608-2:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022) (Endorsed by Asociación Española de Normalización in July of 2022.)
Sistemas de inyección por aguja para uso médico. Requisitos y métodos de ensayo. Parte 2: Agujas para plumas de doble punta (ISO 11608-2:2022) (Ratificada por la Asociación Española de Normalización en julio de 2022.)
| Standard number: | UNE EN ISO 11608-2:2022 |
| Pages: | 43 |
| Released: | 2022-07-01 |
| Status: | Standard |
UNE EN ISO 11608-2:2022
This document specifies requirements, test methods and compatibility requirements for single-use, double-ended, sterile needles used with needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1. NOTE Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608-3, and hypodermic needles provided separately are covered in ISO 7864. This document is not applicable to: needles for dental use; pre-filled syringe needles; needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).