ISO has just released 2 new documents in the ISO 11608 series and both are available now from Document Center Inc. They are the new ISO 11608-1, “Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems,” and ISO 11608-2, “Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles.”
ISO 11608-1:2012 covers needle-based injection systems (referred to as NISs) primarily intended for human use. It provides performance requirements regarding essential aspects so that variations of design are not unnecessarily restricted. Containers covered in this part of ISO 11608 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user.
The first edition of ISO 11608-1 in 2000 introduced the concept of interchangeability and the labeling designations “Type A” (i.e. interchangeable) and “non-Type A” for needles and container systems. Since it was released, experience has shown that the complexity of these systems makes it very difficult to ensure functional compatibility, particularly when products are made by different manufacturers.
Based on this experience, the labelling designation “Type A” has been removed. The design requirements related to system function have been maintained as a guide to assist manufacturers during the design phase, supporting the achievement of cross-platform compatibility. However, these design requirements are an insufficient replacement for system testing of the components and, where possible, direct communication and/or quality agreements between system component manufacturers.
Given the patient convenience benefits associated with cross-platform compatibility, manufacturers of needles, containers and needle-based injectors need to label their products with the specific system components that have been tested and demonstrated to be functionally compatible.
ISO 11608-2:2012 covers sterile double-ended needles intended for single use in conjunction with needle-based injection systems (e.g. pen injectors). These needles are often referred to as pen needles.
Again, the labelling designation “Type A” has been removed. Flow rate is introduced as a new parameter. However, this part of ISO 11608 does not specify requirements or test methods for freedom from biological hazards because no international agreement on the methodology and the pass/fail criteria has been reached.
The sampling plans for inspection selected for this part of ISO 11608 are intended to verify, at a high confidence level, the manufacturer’s ability to manufacture one “lot” of needles that conforms to the critical product attributes. The sampling plans for inspection do not replace the more general manufacturing quality systems that appear in standards on quality systems, for example ISO 9000.
The other standards in this series are:
ISO 11608-3:2000, “Pen-injectors for medical use — Part 3: Finished cartridges — Requirements and test methods”
ISO 11608-4:2006, “Pen-injectors for medical use — Part 4: Requirements and test methods for electronic and electromechanical pen-injectors”
ISO 11608-5, 2011 Draft, “Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions”
ISO 11608-3 is due to be revised soon.
All ISO standards, and many obsolete revision as well, are available from Document Center Inc. at our website, www.document-center.com. Or you can get in touch with us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We can assist you with all your compliance documentation requirements.