Standards and labels

• EN 149:2001+A1:2009

  EN 149:2001+A1:2009 is a European standard for filtering half masks for protecting against particles and it is an amendment of EN 149:2001. It outlines additional requirements for mask design and performance testing. The mask must be able to filter a certain percentage of particles, have good breathability, and fit securely to the face. The test results shows how well the mask filters and how easy it is to breathe through, also it includes a test for the mask's ability to fit securely to the face. It also specifies the mask's ability to filter out specific airborne particles like dust, mist, and fumes. It includes additional requirements for the performance of the mask, such as the ability to seal against the face and the mask's durability.

  Test results

  Reusability NR - Not Reusable

  The standard EN 149:2001+A1:2009 designates a classification for filtering half masks, distinguishing between those that are re-usable (R) and non-reusable (NR). When a mask is classified as NR - Not Reusable, as per the result identified for EN 149:2001+A1:2009 NR, it implies that the mask is intended for single use only and should not be used more than once. The test method for determining reusability under this standard involves assessing the mask's material integrity, filter efficiency, and structural stability after simulated use, which might include cleaning, disinfection, and aging procedures. The practical implications of this result are significant; masks labeled as NR must be discarded after one use, highlighting a critical consideration for procurement professionals in terms of inventory, cost management, and usage protocols to ensure safety and compliance.

• CE Marking

  CE Marking is a label that shows a product meets certain safety and environmental standards set by the European Union. To get the CE Marking, a company must test and certify their product meets these standards. CE Marking is required for many products sold in the EU, including electronics, machinery, toys and medical devices. It helps ensure that products are safe for consumers and the environment, and allows for easy trade within the EU.

• MD Label

  MD stands for "Medical Device." It refers to any instruments, apparatus, machines, implants, or other similar or related articles that are intended to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disability. In Europe, a MD Label is a special label that must be on all Medical Devices that are sold or used in the European Union (EU). The label must include information about the product, such as the name of the manufacturer, the intended use of the product and CE mark. To be able to sell or use a Medical Device in the EU, the device must meet certain standards and requirements set by the European Union and notified body.