ISO 11608:2022
ISO 11608:2022 Needle-based injection systems for medical use – Requirements and test methods – Part 3: Containers and integrated fluid paths
CDN $307.00
Description
This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.
It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.
This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022).
This document is not applicable to the following products:
-    sterile hypodermic needles;
-    sterile hypodermic syringes;
-    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.
Edition
3
Published Date
2022-04-07
Status
PUBLISHED
Pages
27
Language
English
Format
Secure PDF
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Abstract
This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.
It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.
This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022).
This document is not applicable to the following products:
-    sterile hypodermic needles;
-    sterile hypodermic syringes;
-    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.
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