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  • BSI
    20/30382352 DC BS EN ISO 11608-3. Needle-based injection systems for medical use. Requirements and test methods - Part 3. NIS containers and integrated fluid paths
    Edition: 2020
    $44.66
    / user per year

Description of 20/30382352 DC 2020

This document specifies requirements and test methods for design verification of containers and integrated fluid paths to be used with Needle-Based Injection Systems (NIS) that fulfil the requirements of ISO 11608-1 (and other subparts as appropriate). It is applicable to single and multi-dose containers (either filled by the manufacturer [primary container closure] or by the end-user [reservoir]) and fluid paths that are integrated with the NIS at the point of manufacture.

NOTE

Prefilled syringes (ISO 11040-8) are included in the scope when used with a NIS; see also scope of ISO 11608-1:20xx.

Products excluded from scope are:

  • sterile hypodermic needles for single use;

  • sterile hypodermic syringes for single use;

  • sterile single-use syringes, with or without needle, for insulin;

  • containers that can be refilled multiple times;

  • containers intended for dental use;

  • catheters or infusion sets that are attached or assembled separately by the user.



Standard Number20/30382352 DC
TitleBS EN ISO 11608-3. Needle-based injection systems for medical use. Requirements and test methods - Part 3. NIS containers and integrated fluid paths
StatusDefinitive
Publication Date2020-02-28
Identical National Standard OfISO/DIS 11608-3
DescriptorsLeak tests, Design, Medical equipment, Injection guns, Containers, Injection instruments, Performance testing, Drug administration, Medical instruments, Parenteral infusion equipment, Measuring cylinders, Dimensions, Performance, Syringes
ICS11.040.25 Syringes, needles and catheters
CommitteeCH/84
PublisherBSI
Pages34

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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