BS EN ISO 8362-5:2016规定了形状、尺寸、材料、性能要求和 如ISO 8362-1和ISO 8362-4所述，注射瓶封口类型的标签 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。注意药品在生产和储存期间的效力、纯度、稳定性和安全性 会受到初级包装的性质和性能的强烈影响。交叉引用:ISO 48ISO 3302-1ISO 3302-2ISO 7619-1ISO 8871-1ISO 8871-4ISO 8871-5:2005ISO 554ISO 2230ISO 15378购买本文件时提供的所有当前修订版均包含在购买本文件中。

BS EN 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.Cross References:ISO 48ISO 3302-1ISO 3302-2ISO 7619-1ISO 8871-1ISO 8871-4ISO 8871-5:2005ISO 554ISO 2230ISO 15378All current amendments available at time of purchase are included with the purchase of this document.