Kolmi Oxygen Mask FFP2 NR D &, Type IIR, Size L, White

Standards and labels

• ISO 13485:2016

  ISO 13485:2016 is a standard that specifies requirements for a quality management system for the design and manufacture of medical devices. It includes requirements for how companies should design, implement, maintain and improve their quality management system to ensure that their medical devices are safe and effective. Test results can include information on how well the quality management system is functioning, how well it is being followed, and how effective it is in preventing defects. The standard also includes requirements for how the company should document and record their quality management system performance and continuously improve it.

  Test results

  Medical Management Passed

  The ISO 13485:2016 standard is specifically tailored for medical device manufacturers and aims to ensure the quality and safety of medical devices throughout their production and lifecycle. A test result of Passed in the context of the ISO 13485:2016 standard signifies that the medical device manufacturing management system under assessment has successfully met all regulatory and safety requirements stipulated in the standard. This encompasses rigorous evaluations of the manufacturer's quality management system, including processes like risk management, regulatory compliance, and effective process control. The assessment involves auditing processes such as document review, facility inspection, and staff interviews, to verify the adequacy and effectiveness of the quality management system. Meeting the ISO 13485:2016 requirements assists manufacturers in achieving and maintaining regulatory compliance and ensures that their products consistently meet user needs and applicable regulatory standards, which is crucial for entry and continued presence in global markets.

• 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

  Dolomite Test D

  The EN 149:2001+A1:2009 Dolomite Test, conducted within the framework of EU standards, assesses the resistance of respiratory protective filter masks to clogging by dolomite dust, thus ensuring longer-lasting filter performance under dusty conditions. A result labeled as D in the context of this test indicates that the mask has passed the dolomite dust clogging test and can maintain good breathing resistance over an extended period in a dusty environment, making it suitable for use in high particulate environments. The test method involves exposing the respiratory mask's filter to dolomite dust under controlled conditions and measuring its resistance to clogging (breathing resistance before and after exposure). After successfully passing this test, the mask can be marked with the letter D to signify its performance level, assisting employers or workers in making informed decisions regarding the level of respiratory protection required for specific industrial settings.

  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.

• EN 14683:2019

  EN 14683 is a European standard for face masks. It includes requirements for mask design, testing, and labeling. Test results include things like filtration efficiency and breathability. The standard also includes requirements for packaging and labeling. The 2019 version updates the previous 2014 version.

  Reach out to ask about the standard test results

• 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.

  Test results

  Service Reliability Passed

• EN ISO 11737-1:2006

  EN ISO 11737-1:2006 is a standard that tells how to make sure medical devices are cleaned and sterilized properly before they are used on people. It includes rules for the methods used to clean and sterilize the device and how to test to make sure the cleaning and sterilization process was successful. Test results should show that the device is clean and free from harmful microorganisms. It was published in 2006.

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• 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.

• PPE Category 3

  PPE stands for "personal protective equipment." PPE Category 3 refers to equipment that is complex and provide the highest level of protection such as powered respirators, SCBA, and full body suits. In Europe, PPE Category 3 must meet certain safety standards set by the European Union, which means that it must be designed and manufactured to protect the user without causing harm. Companies that make or sell PPE must prove that it meets these standards. They also must have a quality management system in place, have to be audited regularly by a notified body and have to have a technical documentation.