BS EN ISO 7886-1:2018规定了验证空无菌一次性皮下注射器设计的要求和试验方法，该注射器由塑料或其他材料制成，带有或不带有针头，用于最终用户灌装后的液体吸入和注射。本文件不提供批次放行要求。注射器主要用于人体。本文件中规定的无菌注射器适用于灌装后立即使用，不适用于长时间存放药物。它不包括与胰岛素一起使用的注射器（见ISO 8537）、由玻璃制成的一次性注射器、与电源一起使用的注射器- 驱动注射泵、制造商预先填充的注射器，以及填充后准备储存的注射器（例如药剂师填充的药盒）。本文件中未规定针头的皮下注射器适用于ISO 7864中规定的皮下针头。交叉引用:ISO 23908:2011 Ed 1ISO 15223-1:2016ISO 80369-7:2016ISO 14971:2007ISO 8601:2004 Ed 3ISO 384:2015ISO 11607-2:2006（R10）Ed 1IEC 62366-1:2015ISO 11607-1:2006（R10）Ed 1ISO 80369-20:2015ISO 15223-2:2010 Ed 1ISO 8537:2016ISO 10993-1:2009ISO 7864:2016购买本文件时可提供的所有当前修订。

BS EN ISO 7886-1:2018 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans.Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time.It excludes syringes for use with insulin (see ISO 8537 ), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist).Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.Cross References:ISO 23908:2011 Ed 1ISO 15223-1:2016ISO 80369-7:2016ISO 14971:2007ISO 8601:2004 Ed 3ISO 384:2015ISO 11607-2:2006 (R10) Ed 1IEC 62366-1:2015ISO 11607-1:2006 (R10) Ed 1ISO 80369-20:2015ISO 15223-2:2010 Ed 1ISO 8537:2016ISO 10993-1:2009ISO 7864:2016All current amendments available at time of purchase are included with the purchase of this document.