What is the standardization required during the manufacturing of masks?
Every mask has to pass through the standardization level. This is a mandatory fact. But some of the mask manufacturers stay in obscurity to save cash. However, we are talking about human safety from catching a deadly variant. So, everything needs to be up-to-date. However, due to the current COVID crisis, many people have returned to the internet for more information about the type of products they use and also want to know its effect of it. And there are many articles found on the internet that provide cover stories, facts, and bullet points that help understand the true situation, combat confusion about regulatory bodies, and truly understand under what conditions a manufacturer of face mask does so.
Examples
1. Surgical Mask: This class 1 medical device, worn by clinical workers, is designed to prevent them from infecting their patients. Following the standards (EN 14683), which are harmonised under the Medical Devices Directive, is the only practicable option to comply with the CE marking standards.
2. Protective face shields: They are personal protective equipment (PPE), and because they are designed to protect against harmful biological agents, they fall into the highest category of PPE (Cat III) under the classification system for that regulation (which is completely different from the classification system used for medical devices). The PPE Regulation has standardised a standard (EN 166), and adhering to it is by far the simplest way to demonstrate that you have complied with the requirements for CE marking.
3. Respirators: These (commonly referred to as "FFP2", "FFP3", or "KN95" masks) are also Category III PPE because they are designed to filter particles to prevent the wearer from inhaling them. If they are to receive a CE mark, they must meet the EN 149 performance requirements.
4. Category III PPE: It must be independently type-tested and produced using a quality control system that has received the endorsement of a Notified Body. Without the assistance of a notified body, the producer can CE mark Class 1 medical products.
Subliming the Confusions
There is no such thing as an "EN 166 category 1 face shield" since the regulation, not the standard, determines the category. Furthermore, even if a product manufacturer calls their product a "medical face shield," that does not alter the requirement that it be certified as PPE rather than medical equipment.
Although surgical face masks may offer some level of protection for the user, EN 14683 does not address this in a way that offers the level of protection necessary for PPE. A mask that complies with the PPE Regulation must be worn if the wearer needs protection.
It is theoretically possible to CE mark a face shield as a medical device, but there is no benchmark for this. Since the manufacturer must have clear proof that the device offers a medical benefit in response to one or more specific illnesses or disabilities, the rules for CE marking medical devices make it more likely that it will cost more and take longer than the Notified Body procedure for PPE.
Conclusion
A face mask protects you and your loved ones from catching this disease, provided the face mask manufacturer gets it approved by the authorities. If this is not done, the effectiveness of the face mask is compromised.
Examples
1. Surgical Mask: This class 1 medical device, worn by clinical workers, is designed to prevent them from infecting their patients. Following the standards (EN 14683), which are harmonised under the Medical Devices Directive, is the only practicable option to comply with the CE marking standards.
2. Protective face shields: They are personal protective equipment (PPE), and because they are designed to protect against harmful biological agents, they fall into the highest category of PPE (Cat III) under the classification system for that regulation (which is completely different from the classification system used for medical devices). The PPE Regulation has standardised a standard (EN 166), and adhering to it is by far the simplest way to demonstrate that you have complied with the requirements for CE marking.
3. Respirators: These (commonly referred to as "FFP2", "FFP3", or "KN95" masks) are also Category III PPE because they are designed to filter particles to prevent the wearer from inhaling them. If they are to receive a CE mark, they must meet the EN 149 performance requirements.
4. Category III PPE: It must be independently type-tested and produced using a quality control system that has received the endorsement of a Notified Body. Without the assistance of a notified body, the producer can CE mark Class 1 medical products.
Subliming the Confusions
There is no such thing as an "EN 166 category 1 face shield" since the regulation, not the standard, determines the category. Furthermore, even if a product manufacturer calls their product a "medical face shield," that does not alter the requirement that it be certified as PPE rather than medical equipment.
Although surgical face masks may offer some level of protection for the user, EN 14683 does not address this in a way that offers the level of protection necessary for PPE. A mask that complies with the PPE Regulation must be worn if the wearer needs protection.
It is theoretically possible to CE mark a face shield as a medical device, but there is no benchmark for this. Since the manufacturer must have clear proof that the device offers a medical benefit in response to one or more specific illnesses or disabilities, the rules for CE marking medical devices make it more likely that it will cost more and take longer than the Notified Body procedure for PPE.
Conclusion
A face mask protects you and your loved ones from catching this disease, provided the face mask manufacturer gets it approved by the authorities. If this is not done, the effectiveness of the face mask is compromised.
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