Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems. Convert Swiss francs (CHF) to your currency.

It provides performance requirements and characteristics so that variations of design are not unnecessarily restricted. The document does not cover needle-free injectors.

The ISO 11608 series includes requirements for design verification of the NIS’s conformance with its design specification. The sampling plans, preconditioning criteria and other aspects of testing

Since ISO 11608-1 was first published in 2000, the series has set the standards for how needle-based injection devices should be designed and verified. This year, the series received its biggest update in a decade. Here is what device manufacturers need to know.

This part of ISO 11608 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in this part of ISO 11608 include single- and multi-dose syringe-based and cartridge-based systems, filled either

Apr 1, 2021 · Anyone who works with injection devices will be familiar with the ISO 11608 series of standards. The standards cover requirements, test methods, and design guidance for needle-based injection systems, and they are currently nearing the end of the most comprehensive review and update since 2012.

ISO 11608 is a testing standard that describes the functional requirements for needle-based injection systems (NIS). It is critical that biomedical manufacturers perform thorough testing of these devices during development and production, due to …

The ISO 11608 series deals with “hand-held” or “on-body” delivery systems (OBDSs). By hand-held, users (patients or caregivers) control and stabilize the NIS at the injection site during administration

ISO 11608-1 is the international standard that ensures the safety, accuracy, and performance of Needle-Based Injection Systems (NIS), including autoinjectors, pen injectors, and other drug delivery devices.

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.