Hardlines

SGS Recommends Changes to Test Plan for FDA 510(k) Premarket Submissions for Medical Face Masks

The U.S. Food and Drug Administration (FDA) has clarified the requirements for 510(k), a premarket submission that demonstrates a medical device is safe and effective before it is marketed. The clarification has increased the sample size requirements for medical face masks. To market Class I, II, or III medical devices for human use in the […]

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SGS Details North American Flammability Standards for Tents and Sleeping Bags

SGS, the world’s leading inspection, verification, testing and certification service provider, has published details of the flammability standards that tents and sleeping bags must conform to in North America. This advice comes at a time of growth in the camping market as consumers look for alternatives to flying during the COVID-19 pandemic. A recent survey

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EU Introduces New Test Standard for ‘Accelerated Wear and Corrosion for Nickel Release from Coated Items’

The European Committee for Standardization (CEN) has published a new method for simulating wear and corrosion for the detection of nickel release from coated items. Published in September 2020, EN 12472:2020 ‘Method for the simulation of accelerated wear and corrosion for the detection of nickel release from coated items’, should be used prior to detecting

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Vietnam Releases Draft Technical Regulation to Restrict Lead Content in Paints

Vietnam signals its intention to regulate lead content in paint products with a draft technical regulation – Vietnam National Technical Regulations on Limiting Lead Content in Paints (QCVN:2020/BCT). The draft technical regulation includes various important provisions: Defining the methods for sampling and lead determination: Sampling – TCVN 2090:2015 (ISO 15528:2013) Determination – CPSC-CH-E100309-01 Reducing the

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Health Canada Updates Industry Safety Requirements Guide for Children’s Toys and Related Products

Health Canada has published and updated version of its industry guide to help manufacturers of children’s toys and related products conform to the requirements under the Toys Regulation (SOR/2011-17). “Industry Guide to Health Canada’s Safety Requirements for Children’s Toys and Related Products” was published on August 27, 2020. It contains several updates, including: Corrections to

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SGS gains IECEE Test Laboratory Qualification to test and certify electronic furniture

SGS, the world’s leading inspection, verification, testing and certification company, is one of the first organizations to gain the IECEE Test Laboratory Qualification to test and certify electronic furniture against IEC 60335-2-116:2019 standards within the Certification Body (CB) scheme. A rise in the volume of furniture with electrically motorized parts reaching global markets has increased

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Vermont Issues Guidance for CHCC Reporting Under Children’s Products Rule

The US state of Vermont’s Department of Health (DoH) has published guidance to help economic operators in the children’s product sector comply with the latest reporting requirements relating to chemicals of high concern to children (CHCC) in the Children’s Product Rule. The guidance document – September 2020 Chemical Disclosure Guidance for Manufacturers – contains multiple

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Ukraine Seeks Closer Alignment with EU Toy Safety Regulations

Ukraine has published a draft resolution that, if accepted, will bring its toy safety legislation into closer alignment with the European Union’s Directive 2009/48/EC, the so-called European Toy Safety Directive (TSD). The draft resolution – Draft Resolution of the Cabinet of Ministers of Ukraine On Amendments to the Technical Regulations for Toy Safety – was

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EU Could Introduce Aniline Restrictions for Some Toy Materials

European Union (EU) releases proposal to restrict aniline in specific toy materials. According to the proposal circulated by the World Trade Organization (WTO) on September 8, 2020, the EU proposes aniline restrictions on textiles and leather materials, and in finger paints. These will be restricted under Appendix C to Annex II of Directive 2009/48/EC, the

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