In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances
EU. Hazardous Substances for Purposes of Art. 5(2) and Annex I of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, 5 May 2017, as corrected 27 December 2019
This list contains a non-exhaustive inventory of hazardous substances for purposes of Regulation (EU) 2017/746, including Chap. 2 (Placing on the market and putting into service) and Annex I (General Safety and Performance Requirements). It is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list).
This category encompasses the various chemical substances manufactured in the production of inorganic glasses. For purposes of this category, 'glass' is defined as an amorfous, inorganic, transparent, translucent or opaque material traditionally formed by fusion of sources of silica with a flux, such as an alkali-metal carbonate, boron oxide, etc. and a stabilizer, into a mass which is cooled to a rigid condition without crystallization in the case of transparent or liquid-phase separated glass or with controlled crystallization in the case of glass-ceramics. The category consists of the various chemical substances, other than by-products or impurities, which are formed during the production of various glasses and concurrently incorporated into a glass mixture. All glasses contain one or more of these substances, but few, if any, contain all of them. The elements listed below are principally present as components of oxide systems but some may also be present as halides or chalcogenides, in multiple oxidation states, or in more complex compounds. Trace amounts of other oxides or chemical compounds may be present. Oxides of the first seven elements listed* comprise more than 95 percent, by weight, of the glass produced. @Aluminium*@Lead@Boron*@Lithium@Calcium*@Manganese@Magnesium*@Molybdenum@Potassium*@Neodymium@Silicon*@Nickel@Sodium*@Niobium@Antimony@Nitrogen@Arsenic@Phosphorus@Barium@Praseodymium@Bismuth@Rubidium@Cadmium@Selenium@Carbon@Silver@Cerium@Strontium@Cesium@Sulfur@Chromium@Tellurium@Cobalt@Tin@Copper@Titanium@Germanium@Tungsten@Gold@Uranium@Holmium@Vanadium@Iron@Zinc@Lanthanum@Zirconium
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