標準號：DIN EN 455-4-2009
中文標準名稱：一次性醫用手套.第4部分:貨架壽命測定的要求和試驗,德文版本EN 455-4:2009
英文標準名稱：Medical gloves for single use - Part 4: Requirements and testing for shelf life determination; English version of DIN EN 455-4:2009-10
標準類型：C48
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C48
國際標準分類號：11.140
引用標準：EN 455;EN 1041;EN ISO 11607
適用范圍：This part of EN 455 specifies requirements for shelf life for medical gloves for single use. It also specifies therequirements for labelling and the disclosure of information relevant to the test methods used.This European Standard applies to existing, new and significantly changed designs. Existing designs that do notcurrently have ageing data available should generate that data within a reasonable period of time.This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associatedwith the distribution and control of very large lots. The recommended maximum individual lot size for production is500 000.