ISO13485医疗器械质量管理体系标准（用于医用口罩EN13485标准）

口罩级别:FFP1过滤率大于80%, FFP2过滤率大于94%, FFP3大于99%

口罩工厂需要过体系ISO13485知识分享

EN 14387 空气过滤器和组合过滤器

EN14387 :2004+A1:2008 Respiratory protective devices - Gas filter(s) and combined filter(s) - Requirements, testing, marking

EN 143:2000/A1:2006 Respiratory protective devices-Particle filters-Requirements, testing, marking

EN 149可防护微粒的过滤式半面罩

EN 149:2001+A1:2009 Respiratory protective devices-Filtering half masks to protect against particles-Require-ments, testing, marking

EN 136 全面罩 类别1、类别2，类别3

EN 136:1998Respiratory protective devices- Full face masks- Requirements, testing, marking

EN 140半面罩/四分之一面罩

EN 140:1998/AC:1999 Respiratory protective devices - Half masks and quarter masks - Requirements, testing, marking

EN 143微粒过滤器