ISO 11608-1 Needle Based Injection Systems for Medical Use - Part 1: Needle Based Injection Systems

Material Testing

ISO 11608-1 Needle Based Injection Systems for Medical Use - Part 1: Needle Based Injection Systems

EUROLAB laboratory provides testing and compliance services within the scope of ISO 11608-1 standard. Developed by the International Organization for Standardization (ISO), the ISO 11608-1 standard specifies requirements and test methods for needle-based injection systems (NISs) intended for use with needles and replaceable or non-replaceable containers. Containers covered by ISO 11608-1 include single and multiple dose syringe-based and cartridge-based systems filled by the manufacturer or the end user.

ISO 11608-1 Needle Based Injection Systems for Medical Use - Part 1: Needle Based Injection Systems

This part of ISO 11608 covers needle-based injection systems (referred to as NISs) primarily for human use. Provides essential performance requirements so that design variations are not unduly constrained. This part of ISO 11608 should be used in conjunction with other parts of ISO 11608.

The first edition of this part of ISO 11608 introduced the concept of interchangeability and the definitions of "Type A" (i.e. replaceable) and "non-Type A" labeling for needles and container systems. Since its publication, experience has shown that the complexity of these systems makes it very difficult to achieve functional compatibility as defined in different sections of this International Standard, especially when products are made by different manufacturers. Based on this experience, it is believed that the Type A designation does not provide sufficient guidance to the user when deciding on the compatibility of needles and containers with certain needle-based injector systems. Therefore, the "Type A" labeling designation has been removed.

The design requirements for system functionality have been retained as a guideline to assist manufacturers in the design phase and to support cross-platform compatibility. However, these design requirements are an inadequate substitute for system testing of components and, where possible, for direct communication and/or quality agreements between system component manufacturers. Therefore, given the patient comfort benefits associated with cross-platform compatibility, manufacturers of needles, containers, and needle-based syringes should label their products with specific system components that have been tested and proven to be functionally compatible.

The sampling plans for review chosen for this part of ISO 11608 aim to validate the design with a high level of confidence. Sampling plans for inspection do not replace the more general production quality systems that appear in standards in quality systems, such as the ISO 9000 series and ISO 13485. The materials to be used for construction are not specified, as its selection will depend on the design, the intended use and the manufacturing process used by the individual manufacturers.

There are other international and national standards and guidance publications, and in some countries national regulations that apply to medical devices and drugs. Its requirements may replace or supplement this part of ISO 11608. NIS developers and manufacturers are encouraged to investigate and determine if there are other requirements regarding the safety or marketability of their products.

Manufacturers are expected to follow a risk-based approach during the design, development and manufacture of the product. Given the specific medicinal product and intended use, this may result in product-specific requirements and test methods that differ from those outlined in this part of ISO 11608.

Among the services provided by our organization within the framework of material testing services, there are also ISO 11608-1 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.

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