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Face Mask Regulations and Standards in the EU: An Overview

There are several accredited testing companies that provide MDD testing services for face mask products, which include Bureau Veritas, SGS, Intertek, and TUV. Quality Management System (ISO 13485) If your surgical masks are classified as sterile, then the MDD requires that the manufacturer has a quality management system (QMS) in place.

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Respiratory Protection and Surgical Face Mask CE Certificate

Manufacturers have to characterize and classify surgical face masks in type I or II in the European market and in level 1, 2 ot 3 for the American market. Evaluation of surgical masks in Europe. In Europe, surgical masks must wear a CE mark and comply with the requirements defined in EN 14683: Medical face masks - Requirements and test methods.

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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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Specifications of quality surgical masks and N95 respirators Surgical mask . In contrast to a thin, single-layered or double-layered paper mask, a surgical mask usually consists of three layers of flat or pleated fabric. Ideally, a surgical mask: Has the manufacturer’s name printed on its packaging.

Personal Protective Equipment (PPE) - SGS

Personal Protective Equipment (PPE) testing and certification from SGS – ensure your products comply with Regulation, 2016/425. PPE is considered to be any item designed to be worn or held by an individual for protection against one or more safety hazards.

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ASTM refers to the American Society of Testing and Materials American Society of Testing and Materials (ASTM). ASTM is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services—including those in healthcare.

Face Mask Regulations and Standards in the US: An Overview

Surgical masks, including isolating masks, procedure masks, and dental masks, are classified as class II devices by the FDA. For these devices, manufacturers or importers are required to submit 501(k) premarket notification, and obtain FDA clearance, before placing the product in the market.

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N95 masks differ from other types of surgical masks and face masks because they create a tight seal between the respirator and your face, which helps filter at least 95% of airborne particulates.

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