NA 063-02-03 AA
Packaging systems for loading and application of medical devices
The working committee is responsible for the standardization of primary packaging materials for pharmaceuticals and medical products (applications) and, in close cooperation with the NA 014 "Dentistry Standards Committee", also for cartridges (syringe cylinders) and accessories for dental products. The standardization of quality management systems for primary packaging materials is not within the scope of this working committee (but see NA 063-02-11 Quality management systems for primariy packaging materials"). Primary packaging materials that are within the responsiblity of NA 063-02-03 AA may be made of glass, plastic or other materials. Examples of containers and systems include: - injection bottles, - infusion bottles, - ampoules, - syringe cylinders, - screw-neck bottles, - glass cylinders / cartridges for pen injectors, - prefilled syringes for single use, - application systems, except containers that are within the responsibility of the working committee NA 063-02-02 AA "Transfusion/infusion containers and equipment made from plastics and disposable sample containers for the in-vitro diagnostics". The standardization work covers, in particular, the development of specifications for materials, dimensions, design, the specification of test methods and specific treatments, e.g. siliconization or treatment with other lubricants, as well as the specification of requirements on packaging, sterilization, labeling and information to be provided by the manufacturer.