ISO 11608-2 Needle Based Injection Systems for Medical Use - Part 2: Needles

EUROLAB laboratory provides testing and compliance services within the scope of ISO 11608-2 standard. Developed by the International Organization for Standardization (ISO), the ISO 11608-2 standard specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) meeting the specifications of ISO 11608-1.

ISO 11608-2 does not apply to needles for dental use, pre-assembled needles by the manufacturer, and needles that do not require assembly or connection to the NIS.

This part of ISO 11608 covers sterile double-ended needles intended for single use with needle-based injection systems (eg pen injectors). These needles are often called pen needles. The devices described in this section of ISO 11608 are designed for use with the devices described in ISO 11608-1 and ISO 11608-3.

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 cup closure systems. Since 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 and the design is not validated as a system. 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 container caps with certain needle-based injection systems (NIS). Therefore, the "Type A" labeling designation has been removed.

This second edition of ISO 11608-2 addresses the functional compatibility of the system through testing. Flow rate is introduced as a new parameter. The sampling plans for the audit chosen for this part of ISO 11608 aim to verify with a high level of confidence the manufacturer's ability to produce a "lot" of needles that meet critical product specifications. Sampling plans for inspection do not replace the more general manufacturing quality systems that appear in quality systems standards, such as ISO 9000.

This part of ISO 11608 does not specify requirements or test methods for biohazard removal, as no international agreement on the methodology and pass/fail criteria has been reached. Guidelines for biological testing of double-pointed needles are provided in ISO 10993-1 and manufacturers are encouraged to consider this guideline when evaluating products. Such an assessment should include the effects of the sterilization process. However, in some countries there may be national regulations that may take precedence over the guidance in ISO 10993-1.

Some countries have national regulations and their requirements may replace or supplement this part of ISO 11608.

Among the services provided by our organization within the framework of material testing services, there are also ISO 11608-2 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.