Franz Mensch Sterile Gowns, SMS

Standards and labels

• EN 13795:2011

  EN 13795:2011 is a European standard that defines the performance requirements and test methods for surgical drapes, gowns, and clean air suits used in medical procedures. It sets guidelines for testing the barrier properties of the material, its resistance to penetration, its flame resistance, and its resistance to liquid penetration. The standard assigns each product a classification based on its performance in the test. Test results for products under this standard will show the product's classification, as well as its barrier properties, resistance to penetration, flame resistance properties and resistance to liquid penetration. This standard helps to ensure that the surgical drapes, gowns, and clean air suits used in medical procedures provide the appropriate level of protection and safety.

  Reach out to ask about the standard test results

• 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.

• Sterile

  Sterile refers to the absence of living microorganisms, including bacteria, viruses, fungi and spores. Sterility is achieved through various methods such as cleaning, filtration, radiation, and chemical treatments. Sterility is a requirement in many medical and laboratory settings, as well as in the production of certain food and drink products. The requirements for a sterile product or environment will depend on the specific application, but generally it should be free from any living microorganisms, it should be easy to maintain and keep clean, it should be safe for people to use, it should be able to maintain its sterility over time. Sterility is important in many medical and laboratory settings, as well as in the production of certain food and drink products to ensure that they are safe for consumption.

• 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.