EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database 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).

Last updated 18 lipnja 2024. Database contains 4917 unique substances/entries.
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F Fungi
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Acute Tox. 4
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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1314-04-1
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
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Glass Wool EC / List no: - | CAS no: 308066-92-4
Glass, oxide, chemicals
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
EC / List no: 266-046-0 | CAS no: 65997-17-3
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Carc. 2
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12673-58-4
Carc. 1A; STOT RE 1; Skin Sens. 1
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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7411-47-4
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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29873-36-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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B Bacteria and similar species
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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2810-74-4
Acute Tox. 4
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P Parasites
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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P Parasites
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B Bacteria and similar species
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B Bacteria and similar species
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F Fungi
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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65229-23-4
Carc. 1A; STOT RE 1; Skin Sens. 1
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16039-61-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
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11132-10-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
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60999-18-0
Acute Tox. 3; STOT RE 2
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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