标准号:DIN EN 455-4-2009
中文标准名称:一次性医用手套.第4部分:货架寿命测定的要求和试验,德文版本EN 455-4:2009
英文标准名称:Medical gloves for single use - Part 4: Requirements and testing for shelf life determination; English version of DIN EN 455-4:2009-10
标准类型:C48
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:C48
国际标准分类号:11.140
引用标准:EN 455;EN 1041;EN ISO 11607
适用范围: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.