标准号:DIN EN ISO 8537-2008
中文标准名称:胰岛素用有或无针头一次性无菌注射器
英文标准名称:Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007); English version of DIN EN ISO 8537:2008-10
标准类型:C31
发布日期:1999/12/31 12:00:00
实施日期:1999/12/31 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 594-1-1996;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-IO0).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.