ISO 23908:2011 尖锐物刺伤保护 要求和试验方法 一次性使用的皮下注射针头、导尿管的导引器和抽血用针头的尖锐物保护特征

标准编号：ISO 23908:2011

中文名称：尖锐物刺伤保护 要求和试验方法 一次性使用的皮下注射针头、导尿管的导引器和抽血用针头的尖锐物保护特征

英文名称：Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

发布日期：2011-06

标准范围

ISO 23908:2011给出了评估医疗器械（包括一次性使用的（锋利）皮下注射针、导管和刺血针的导入器以及血液取样中使用的其他针头）的锐器伤害保护功能（无论是主动还是被动）性能参数的要求和测试方法。其所覆盖的锐器伤害保护装置可与装置集成或在使用前与装置结合，以实现锐器伤害防护。本规范未对预期使用前的锐器保护装置或医疗器械本身的储存和处理提出要求。

ISO 23908:2011 gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection.It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself.

标准预览图