Product description
- Medical Protection
- Hand Protection
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Standards and labels
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.
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.
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.
Berner delivery terms
Free delivery when you order more than 500,00 € from Berner
Supplier shipping fee 30,00 €
Brand minimum 50,00 €
Mercator RD30083003 Nitrile gloves, 100 pcs
132,69 € / carton (VAT incl.)
105,73 €
carton VAT 0%
A carton contains 10 packages (1 000 pcs)
10,57 € / 100 pcs
In a package
100 pieces
In a carton
10 packages
1 000 pieces
Berner
Delivery time: 2 business days
Orders from 50,00 €
Supplier shipping fee 30,00 €
Free shipping on orders over 500,00 €
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