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Standards Development
This document specifies the material, performance requirements and labelling, and gives recommendations for shape and dimensions of plunger stoppers used in cartridge-type needle-based injection systems (NIS) for medical use, in accordance with ISO 11608-3. The document applies to the plunger stoppers as supplied by the manufacturer (i.e., washed, unsterilized or sterilized). The dimensions are applicable to plunger stoppers that are not laminated/coated and plunger stoppers that are laminated/coated.
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