BS EN ISO 8537-2008 带或不带针头的一次性使用无菌胰岛素注射器

标准号：BS EN ISO 8537-2008
中文标准名称：带或不带针头的一次性使用无菌胰岛素注射器
英文标准名称：Sterile single-use syringes, with or without needle, for insulin
标准类型：C31
发布日期：2008/9/30 12:00:00
实施日期：2008/9/30 12:00:00
中国标准分类号：C31
国际标准分类号：11.040.25
引用标准：ISO 594-1-1986;ISO 7864-1993;ISO 9626
适用范围：This International Standard specifies requirements and test methods for sterile syringes, with or withoutneedles, solely for the injection of insulin. The syringes are single-use only, primarily for use in humans. Itcovers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100).Sterile syringes specified in this International Standard are intended for use soon after filling as they are notsuitable for containing insulin over extended periods of time.