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折叠口罩检测认证机构

欧洲市场对于口罩的管理分为两个主要类别,个人防护口罩和医用口罩。个人防护口罩主要是工业用防护,医用口置主要是医院使用.
The management of masks in the European market is divided into two main categories,personal protective masks and medical masks. Personal protective masks are mainly used for industrial protection,and medical mouth masks are mainly used in hospitals.

折叠口罩检测认证机构插图

1.喷熔布/无纺布/防护服检测报告

2.口罩等医疗用品检测报告(带CNAS,CMA标志);

3.CE,FDA;EAC 可在白名单内查询

详情请联系贝斯通检测刘工,在主页

一)医用口罩Medical mask

医用口罩对应的欧洲标准是EN14683 ,该标准对于口罩的分类如下图所示,按照BFE、呼吸阻抗和防喷溅能力分为三个类别。
The corresponding European standard for medical masks is EN14683. The classification of the masks as shown in the figure below is divided into three categories according to BFE, respiratory impedance and splash resistance.

按照医疗器械法规2017/745/EU的要求,口罩产品可以按照一类器械进行管理,依据产品是无菌或非无菌状态提供,其认证模式不一样。
According to the re of the medical device regulation 2017/745 / EU, mask products can be managed according to a class of devices, depending on whether the product is sterile or non-sterile, and the certification mode is different.

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