BS EN 455-4-2009 一次性医用手套.第4部分:测定货架寿命的试验和要求

标准号：BS EN 455-4-2009
中文标准名称：一次性医用手套.第4部分:测定货架寿命的试验和要求
英文标准名称：Medical gloves for single use Part 4: Requirements and testing for shelf life determination
标准类型：G45
发布日期：2009/8/31 12:00:00
实施日期：2009/8/31 12:00:00
中国标准分类号：G45
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.