Opharm Face Mask FFP2 Pink

Standards and labels

• EN ISO 9001:2015

  EN ISO 9001:2015 is a standard that sets out the requirements for a quality management system (QMS). It is a set of guidelines that organizations can follow to ensure that they meet customer requirements and enhance customer satisfaction. The standard is based on the plan-do-check-act model and focuses on continuous improvement. It covers the design, development, production, installation, and servicing of products. Organizations can get certified to this standard, which means that they have been independently audited and found to meet the requirements of the standard. The certification process includes regular audits to ensure that the organization continues to meet the standard's requirements.

  Reach out to ask about the standard test results

• 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.

  Reach out to ask about the standard test results

• Made in Europe

  "Made in Europe" is a label used to indicate that a product has been manufactured or produced in Europe. The European Union (EU) has regulations that set the requirements for the "Made in" label. According to EU rules, products that are labeled as "Made in" must be entirely produced within the EU. This means that all the stages of production, from raw materials to the finished product, must take place within the EU. However, the EU does not have specific rules for labeling a product "Made in Europe" as a whole, because Europe is not a single country but a continent. Each country may have their own regulations for labeling a product "Made in Europe", and it's important to check the regulations of the country where the product will be sold.

• 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.