🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS EN ISO 11608-3:2022:2023 Edition

BS EN ISO 11608-3:2022:2023 Edition

$167.15

Needle-based injection systems for medical use. Requirements and test methods – Containers and integrated fluid paths

Published By Publication Date Number of Pages
BSI 2023 36
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

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.

PDF Catalog

PDF Pages PDF Title
2 undefined
11 4.1 General
12 4.2 Container integrity
4.2.1 Container Closure Integrity (CCI)
4.2.2 Resealability — All multi-dose cartridges or reservoirs with discs
4.2.3 Fragmentation (disc coring) – cartridges or reservoirs with discs
13 4.3 Cannula requirements (as part of the fluid path)
4.3.1 Rigid needles
4.3.2 Soft cannulas
4.4 Fluid line connections
4.5 Medicinal product compatibility
4.5.1 General
14 4.5.2 Medicinal product compatibility with reservoir and integrated fluid path materials
4.5.3 Reservoir and integrated fluid path particulate matter
4.5.4 Reservoir and fluid path pyrogenicity
15 4.5.5 Reservoir and integrated fluid path leachables
4.5.6 Sterilization of the reservoir and/or integrated fluid path
16 4.6 Medicinal product leakage
5.1 Resealability for multi-dose cartridges or reservoirs
17 5.2 Fragmentation (disc coring) – cartridges or reservoirs
18 5.3 Sub-visible particulates
5.4 Visible particulates
6.1 General
6.2 Marking on the unit packaging

Related products

BS EN ISO 11608-3:2022
$167.15