口罩出口欧洲产品强制性CE认证，口罩为PPE个人防护用品，而口罩产品需要通过欧洲CE标志PPE指令新(EU)2016/425 (旧89/686/EEC指令)符合相关标准。
EN 136 全面罩—类别1、2或3。
EN 136:1998 Respiratory protective devices - Full face masks - Requirements, testing, marking
EN 140 半面罩/四分之一面罩
EN140:1998/AC:1999 Respiratory protective devices - Half masks and quarter masks - Requirements, testing, marking
EN 143 微粒过滤器
EN143:2000/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 - Requirements, testing, marking
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
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认证
ISO13485 医疗器械质量管理体系标准
