EU-IMPLANTABLE_MEDICAL_DEVICES-ART_3_ANX_1

Active Implantable Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Directive 90/385/EEC on Active Implantable Medical Devices, 20 July 1990, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This 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). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

Last updated 03 maggio 2024. Database contains 4753 unique substances/entries.
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414-340-6
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Flam. Liq. 3; Acute Tox. 4; STOT SE 2; Eye Dam. 1; Skin Sens. 1
PERGASCRIPT BLACK 20223 AMIDE INTERMEDIATE
420-600-1
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STOT RE 2
VERNETZER TMAG
412-790-8
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Carc. 1B; Muta. 2; STOT RE 2
COMPLEXING AGENT BN
410-650-0
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Eye Dam. 1; Skin Sens. 1
423-580-0
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STOT RE 2
423-010-0
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Eye Dam. 1
450-010-8
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Eye Dam. 1; Skin Sens. 1
432-100-9
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Eye Dam. 1
COLUMBIADUNKELBLAU R
415-350-3
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Eye Dam. 1
422-500-1
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STOT RE 2
433-860-4
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Eye Irrit. 2; Skin Sens. 1
EVAPORATED ELEMINOL JS-2 MATERIAL
410-230-7
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Skin Corr. 1B; Skin Sens. 1
TASP
411-250-9
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Skin Sens. 1
427-740-0
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Eye Dam. 1; Skin Sens. 1
DRIMAREN NAVY R-GRL; NAVY 14 08 723
407-100-7
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Skin Sens. 1
PRICARE
411-910-6
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
429-440-5
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Eye Dam. 1
ITC 288/S
410-800-5
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Skin Sens. 1
EBO
417-540-1
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Eye Dam. 1
432-230-6
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STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
438-310-7
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Self-react. C; Repr. 2; Acute Tox. 4; STOT RE 2
ARQUAD 3.16
405-620-9
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Eye Dam. 1
428-260-4
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Eye Dam. 1
428-400-4
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Eye Dam. 1
444-050-5
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Eye Dam. 1
RED MDO 358
414-620-8
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Eye Dam. 1; Skin Sens. 1
NOIR SANDODERM HH 1050; SANDODERM BLACK HH 1050; SANDODERM BLACK R; SANDODERM BLACK R CONC.; SANDODERM SCHWARZ R; SANDODERM SCHWARZ R KONZ.
402-850-1
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Eye Dam. 1
P2-800; P2-935LV
415-870-0
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Skin Sens. 1
GA161895; GLUCAMIDE
411-130-6
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Eye Dam. 1
435-180-3
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Asp. Tox. 1; Skin Irrit. 2
ORANGE LEP 2471
421-290-9
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STOT RE 2
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yes
439-540-0
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Skin Irrit. 2; Skin Sens. 1
431-120-5
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Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
SHC 3000
401-530-9
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Flam. Sol. 1; STOT SE 1; Acute Tox. 4
YELLOW MGI 1301
424-250-9
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Eye Dam. 1
E-101
420-310-3
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Acute Tox. 4
PES-SOLID
420-070-1
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Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
424-510-1
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Eye Dam. 1
PRODUKT 1245
420-980-7
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Eye Dam. 1
PDN 2287
417-450-2
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Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
428-630-5
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Skin Sens. 1
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Carc. 1B; Muta. 2; Acute Tox. 4; Acute Tox. 3; STOT RE 2; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
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Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
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Zirconia Aluminosilicate Refractory Ceramic Fibres
are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.1 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, and fulfil the three following conditions: a) oxides of aluminium, silicon and zirconium are the main components present (in the fibres) within variable concentration ranges b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less micrometres (µm). c) alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content less or equal to 18% by weight
EC / List no: - | CAS no: -
Aluminosilicate Refractory Ceramic Fibres
are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.1 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, and fulfil the three following conditions: a) oxides of aluminium and silicon are the main components present (in the fibres) within variable concentration ranges b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less micrometres (µm) c) alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content less or equal to 18% by weight
EC / List no: - | CAS no: -
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. 1B
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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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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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