標準號：BS EN ISO 8537-2008
中文標準名稱：帶或不帶針頭的一次性使用無菌胰島素注射器
英文標準名稱：Sterile single-use syringes, with or without needle, for insulin
標準類型：C31
發布日期：2008/9/30 12:00:00
實施日期：2008/9/30 12:00:00
中國標準分類號：C31
國際標準分類號：11.040.25
引用標準：ISO 594-1-1986;ISO 7864-1993;ISO 9626
適用范圍：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.