Author Archives: medwea

Medical device manufacturing process

medical device manufacturing

The medical device manufacturing industry caters to healthcare solutions innovatively and competitively. They are designed to help in various stages of healthcare process viz; therapeutics, monitoring, and diagnostics. The overall process in the medical device manufacturing facility encompasses the journey from a design in the boardroom to the safety package of the final product. Medical […]

The importance of face masks for protecting your health

face masks

Face masks have long been used in a variety of ways to protect someone’s health, whether it’s dentists using them in surgeries, construction workers using them to avoid inhaling harmful air pollutants, or any other use — and now with the coronavirus pandemic they are even more vital. Countries around the world have issued “stay […]

浅谈民用口罩标准《GBT 32610-2016》与劳保口罩标准《GB2626-2006》的几个重要区别

自去年《GBT 32610-2016 日常防护型口罩技术规范》正式实施以来,虽然它目前只是个推荐标准,但是越来越多的民用PM2.5口罩产品开始主动执行新国标。毕竟《GBT 32610-2016 日常防护型口罩技术规范》本来就是一个面向民用领域的国标。 1,GBT32610-2016根据口罩的防护效果以及口罩本身的过滤效率将口罩分为A、B、C、D四个等级。   GB2626-2006根据口罩的泄漏率与口罩本身的过滤效率将口罩分为90(KN90、KP90)、95(KN95、KP95)、100(KN100、KP100)三个等级。 以上可见,GBT32610-2016对过滤效率的要求上同时对油性和盐性均有要求,而GB2626-2006仅对盐性或仅对油性颗粒物检测做要求。 2,GBT32610-2016用头模型佩戴口罩来确定防护效果: 而GB2626-2006用真人佩戴口罩检测泄漏率以确定防护效果(防护效果等于100%减去总泄漏率)。 由于使用的头模型不像真人一样脸部有肉,所以,一般情况下,用头模型检测出来的防护效果要比真人检测的防护效果要低。例如某著名国际品牌口罩的KN90型号,耳带式按照GBT32610-2016为B级,即大于85%,头戴式为C级,即大于75%,而其KN95级别的某型号口罩也为B级,即大于85%。 3,GBT32610-2016对呼气阀的气密性没有要求,仅对口罩的总体防护效果有要求。而GB2626-2006对呼气阀的气密性有要求。作为实际防护PM2.5来说,呼气阀的气密性的要求属于多余,因为决定最后佩戴效果的是总体口罩的防护效果,而不是单纯呼气阀的影响。这点和劳保口罩的区别很大。 4,在包装上, GBT32610-2016明确要求每个口罩都要密封包装,而GB2626-2006并没有如此要求,如下 仅要求销售包装能保护产品即可。 5,GBT32610-2016对阻力要求相对GB2626-2006较高: 而GB2626-2006为: ,但是由于目前的技术相对以前先进很多,大部分劳保口罩都可以达到GBT32610-2016的阻力要求。 6,GBT32610-2016对口罩的内部很多有害物质的含量有明确要求,如下: 而,GB2626-2006没有明确数据要求,仅有模糊的说法: 。从这点上,毫无疑问,GBT32610-2016领先很多。 以上为我们认为在日常防护PM2.5中相关性比较强的几个重要区别,如有错误,敬请指正。

Comparison of FFP2, KN95, and N95 and Other Filtering Facepiece Respirator Classes

Filtering facepiece respirators (FFR), which are sometimes called disposable respirators, are subject to various regulatory standards around the world. These standards specify certain required physical properties and performance characteristics in order for respirators to claim compliance with the particular standard. During pandemic or emergency situations, health authorities often reference these standards when making respirator recommendations, […]

Laboratories Accredited by CNAS for Testing of Masks

At present, the accreditation granted by CNAS to laboratories for testing of mask includes Chinese standards and EN standards. 1. Classification and applicable standards of masks in China Testing standards and their applicable scope of masks are as follows: a) GB 19083-2010 is for medical protective masks (GB refers to mandatory national standard); b) GB […]