Objective

To measure the dead space of various syringe volumes and brands and a range of needles gauges commonly used in clinical practice, and to compare the results to the International Organization for Standardization (ISO) standard 7886-1:2018.

Study design

Prospective observational study.

Methods

Syringes of five brands and seven volumes: 1, 2.5, 5, 10, 20, 30, and 60 mL, 10 of each, 10 1 mL low dead space syringes and 10 23, 21 and 18 gauge needles were analysed. Syringe dead space was estimated by weighing each syringe, drawing up and expelling its rated volume of water for injection and re-weighing the syringe. The difference in mass between the two measurements was calculated and converted to a volume based on the density of water. The dead space of the needles was estimated using a similar technique: each needle was attached to a 1 mL syringe of known dead space. A Mettler electronic balance was used for the measurements. Mean dead space was calculated for each syringe volume and needle gauge. Data were compared to the ISO standard.

Results

Syringe dead space for 1 and 2.5 mL was less than 0.07 mL. For 5 mL syringes four of five brands, and for 10 mL syringes one of five brands failed to comply with the ISO; the dead space was greater than 0.075 and 0.1 mL, respectively. For the 20, 30, 60 mL syringes the dead space was less than 0.2 mL. Needle dead space was 0.05 mL for 23 and 21 gauge, and 0.07 mL for 18 gauge, similar in order of magnitude to syringe dead space.

Conclusions

The dead space of syringes differs between brands, and some do not meet the ISO standard. When calculating the amount of drug lost due to dead space, both that of the syringe and needle used should be considered.

中文翻译：

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与国际标准化组织标准 7886-1:2018 相比，注射器和针头死腔的变化

客观的

测量各种注射器容量和品牌以及临床实践中常用的一系列针头规的死腔，并将结果与​​国际标准化组织 (ISO) 标准 7886-1:2018 进行比较。

学习规划

前瞻性观察研究。

方法

对五个品牌和七个容量的注射器进行了分析：1、2.5、5、10、20、30 和 60 mL，各 10 个，10 个 1 mL 低死腔注射器和 10 个 23、21 和 18 号针头。通过对每个注射器称重、抽取和排出其额定体积的注射用水并重新称重注射器来估计注射器死空间。计算两次测量之间的质量差，并将其转换为基于水密度的体积。使用类似技术估计针头的死腔：每根针头都连接到已知死腔的 1 mL 注射器上。Mettler 电子天平用于测量。计算每个注射器体积和针头规格的平均死空间。数据与 ISO 标准进行了比较。

结果

1 mL 和 2.5 mL 的注射器死腔小于 0.07 mL。对于 5 mL 注射器，五个品牌中有四个，而对于 10 mL 注射器，五个品牌中有一个不符合 ISO；死腔分别大于 0.075 和 0.1 mL。对于 20、30、60 mL 注射器，死腔小于 0.2 mL。23 和 21 号规格的针头死区为 0.05 mL，18 号规格的针头死区为 0.07 mL，在数量级上与注射器死区相似。

结论

注射器的死腔因品牌而异，有些不符合ISO标准。在计算由于死腔造成的药物损失量时，应考虑所用注射器和针头的损失量。