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MSZ EN ISO 11608-1:2022

Dokumentumazonosító

179357

Cím

Tűs, injekciós rendszerek gyógyászati használatra. Követelmények és vizsgálati módszerek. 1. rész: Tűs, injekciós rendszerek (ISO 11608-1:2022)

Angol cím

Needle-based injection systems for medical use. Requirements and test methods. Part 1: Needle-based injection systems (ISO 11608-1:2022)

Alkalmazási terület

This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers. This document applies in cases where the NIS incorporates a prefilled syringe. However, stand-alone prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below). It is important to note that other functions and characteristics of the prefilled syringe, such as dose accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document, unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop the plunger movement, which would limit the dose delivered). In that case, the system is completely covered by this document and applicable requirements of the ISO 11608 series. Excluded from the scope are: — stand-alone prefilled syringes defined by ISO 11040-8 (with noted exceptions above); — NISs that provide continuous delivery and require a delivery rate clinically specified in the medicinal product labelling or determined by a physician based on clinical relevance (i.e. medication efficacy) as would be the case with insulin patch pumps or traditional infusion pumps (e.g. IEC 60601-2-24, ISO 28620) associated with continuous delivery of medicinal products (e.g. insulin); — NISs with containers that can be refilled multiple times; — requirements relating to methods or equipment associated with user filling of containers unless they are dedicated accessories (a component necessary for primary function, whether included in the original kitted product or not); — NISs intended for dental use; — NISs intended for different routes of administration (e.g. intravenous, intrathecal, intraocular). NOTE These products that are excluded might benefit from elements in this document but might not completely fulfil the basic safety and effectiveness of such products.

ICS

11.040.25 Fecskendők, tűk és katéterek

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2022-10-01

Forrás

idt EN ISO 11608-1:2022; idt ISO 11608-1:2022

Előd

MSZ EN ISO 11608-1:2015

Utód

Módosítás

Kiegészítő információk

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

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