ISO 8362-5:2016规定了注射瓶类型的形状，尺寸，材料，性能要求和标签，如ISO 8362-1和ISO 8362 4中所述，与冷冻相关使用干燥（或冻干）药物和生物材料。 尺寸要求不适用于屏障涂层封闭件。 ISO 8362本部分规定的关闭仅供一次性使用。 注意药品在其制造和储存过程中的效力，纯度，稳定性和安全性受到初级包装的性质和性能的很大影响

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.