ISO 8362-5:2016规定了注射瓶封口类型的形状、尺寸、材料、性能要求和标签，如ISO 8362-1和ISO 8362-4所述，用于药物和生物材料的冷冻干燥（或冻干）。 尺寸要求不适用于涂有屏障的封闭件。 ISO 8362本部分中规定的封盖仅供一次性使用。 注:药品在生产和储存期间的效力、纯度、稳定性和安全性可能会受到初级包装的性质和性能的强烈影响。

ISO 8362-5:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362？1 and ISO 8362？4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO 8362 are intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.