本文件详细说明了合适的设备、试验方法、验收标准和建议的限制，以帮助确保输血器闭合穿孔装置（本文件中简称“spike”）和血袋出口之间的兼容性（通过测量插入力）。 整个检测程序非常复杂，超出了相关输血器和血袋标准的范围。因此，本文件旨在支持实施现有的血袋和输血器标准。 本文件中描述的程序可供血袋制造商用于测试与市场上可用的输血器尖峰的兼容性，或供输血器尖峰的制造商用于测试与市场上可用的血袋的兼容性。

This document details suitable equipment, a test method, acceptance criteria and advisable limits to help to ensure that there is compatibility (by measuring the insertion force) between a transfusion set closure piercing device (referred to in this document by the abbreviation 'spike') and a blood bag outlet port. The test procedure in its entirety is complex and beyond the scope of each of the relevant transfusion set and blood bag standards. This document was therefore developed to support the implementation of the existing standards for blood bags and transfusion sets. The procedure described in this document can be used by manufacturers of blood bags to test the compatibility with transfusion set spikes available on the market or by manufacturers of the transfusion set spikes to test the compatibility with blood bags available on the market.