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Medical Devices | Life Sciences | SGS

No matter the size of your organization, SGS’s medical device testing, certification, audit and training services can help you navigate the complexities of international medical device regulations to bring your products to market while ensuring compliance with the required regulations and standards and providing a high level of safety to patients and healthcare professionals.

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Apr 03, 2020 · For more information, please refer to the China National Mandatory Standard GB 2626-2019 (Respiratory Protection - Non-powered air-purifying particle respirator) or contact SGS directly. SGS Global Softlines has an extensive network of over 40 laboratories worldwide, with a strong team of committed professionals from multi-disciplinary backgrounds.

Face Mask Regulations and Standards in the EU: An Overview

Compliance Risks. Far from all medical and protective face masks on the market are designed to comply with EU standards and regulations. It’s therefore essential to request and verify all relevant compliance documents and lab test reports, and product labels, before importing face masks from suppliers in China, or other countries.

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Both the Medical Device Directive (93/42 / EEC) and the Medical Device Regulation (EU) 2017/745 specify the information that should appear on the packaging in which the medical face mask is supplied. The following information must be provided: a) number of this European Standard; b) Type of mask (according to the information in the table).

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ABOUT SGS. SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world. sgs. 3 Ply SGS certification medical mask in Italy,N95 mask...

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