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  • BSI
    BS EN ISO 11608-2:2022 - TC Tracked Changes. Needle-based injection systems for medical use. Requirements and test methods - Double-ended pen needles
    Edition: 2022
    $620.36
    / user per year

Description of BS EN ISO 11608-2:2022 - TC 2022

This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle according to ISO 11608-1. This document is not applicable to the following: —    needles for dental use; —    pre-attached syringe needles; —    hypodermic needles; —    needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular); —    materials that form the medicinal product contact surfaces of the primary container closure. However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them. 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.

Standard NumberBS EN ISO 11608-2:2022 - TC
TitleTracked Changes. Needle-based injection systems for medical use. Requirements and test methods - Double-ended pen needles
StatusDefinitive
Publication Date2022-08-12
DescriptorsMarking, Parenteral infusion equipment, Surgical needles, Sterile equipment, Injection guns, Medical equipment, Injection instruments, Disposable, Syringes, Performance testing, Drug administration, Performance, Medical instruments
ICS11.040.25 Syringes, needles and catheters
CommitteeCH/84
ISBN978 0 539 23300 1
PublisherBSI
Pages98

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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