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    ISO 11608-1:2022

    Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
    • 발행일 : 2022-04-07
    • 발행기관 : ISO
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분야 ISO/TC 84 : Devices for administration of medicinal products and catheters
적용범위

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.
국제분류(ICS)코드 11.040.25 : 주사기, 바늘, 카테터
페이지수 69
Edition 4

이력정보

No. 표준번호 표준명 발행일 상태
1 ISO 11608-1:2022상세보기 Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems 2022-04-07 표준
2 ISO 11608-1:2014상세보기 Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems 2014-12-16 구판
3 ISO 11608-1:2012상세보기 Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems 2012-03-30 구판
4 ISO 11608-1:2000상세보기 Pen-injectors for medical use — Part 1: Pen-injectors — Requirements and test methods 2000-12-21 구판

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