EU-IMPLANTABLE_MEDICAL_DEVICES-ART_3_ANX_1
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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 26 April 2024. Database contains 4753 unique substances/entries.
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Cyclopentanecarboxylic acid, 3-(((3-mercapto-2-methoxypropyl)amino)carbonyl)-2,2,3-trimethyl-, mercury complex
EC / List no:
-
| CAS no:
76-31-3
(4-((4-(Dimethylamino)phenyl)azo)phenyl)mercuric acetate
EC / List no:
631-561-5
| CAS no:
19447-62-2
Hydrogen triiodomercurate(1-), compound with 3-methyl-3H-benzothiazol-2-imine (1:1)
EC / List no:
276-613-4
| CAS no:
72379-35-2
Mercury, (3-(2,5-dioxo-1-pyrrolidinyl)-2-methoxypropyl)hydroxy-, compd. with 3,7-dihydro-1,3-dimethyl-1H-purine-2,6-dione (1:1)
EC / List no:
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| CAS no:
747-23-9
Hydrogen [metasilicato(2-)-O](2-methoxyethyl)mercurate(1-)
EC / List no:
264-920-6
| CAS no:
64491-92-5
Benzenesulfonic acid, 4-hydroxy-3,5-diiodo-, mercury(2+) salt (1:1)
EC / List no:
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| CAS no:
515-43-5
Turpentine, Venice, sulfurized, reaction products with hydrogen tetrachloroaurate(-1), sulfurized turpentine oil and mercurous nitrate, mixed with mercurous oxide
EC / List no:
293-784-0
| CAS no:
91082-69-8
Mercury, phenyl((2-phenyldiazenecarbothioic acid-kappaS) 2-phenylhydrazidato-kappaN2)-
EC / List no:
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| CAS no:
12406-51-8
Bis(acetato-O)[μ-[1,3-dioxane-2,5-diylbis(methylene)-C:C',O,O']]dimercury
EC / List no:
281-717-8
| CAS no:
84029-43-6
Mercurate(1-), [dodecenylbutanedioato(2-)-O']phenyl-, hydrogen
EC / List no:
304-575-1
| CAS no:
94276-88-7
[2,2',2''-nitrilotri(ethanol)-N,O,O',O'']phenylmercury lactate
EC / List no:
245-581-3
| CAS no:
23319-66-6
(2',7'-dibromo-3',6'-dihydroxy-3-oxospiro[isobenzofuran-1(3H),9'-[9H]xanthen]-4'-yl)hydroxymercury
EC / List no:
259-779-2
| CAS no:
55728-51-3
Mercury, (3-((((3-carboxy-1-oxopropyl)amino)carbonyl)amino)-2-methoxypropyl)hydroxy-
EC / List no:
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| CAS no:
140-20-5
Tetrakis(acetato-O)[μ4-(3',6'-dihydroxy-3-oxospiro[isobenzofuran-1(3H),9'-[9H]xanthene]-2',4',5',7'-tetrayl)]tetramercury
EC / List no:
259-075-5
| CAS no:
54295-90-8
Hydrogen μ-hydroxy[μ-[orthoborato(3-)-O:O']]diphenyldimercurate(1-)
EC / List no:
304-637-8
| CAS no:
94277-53-9
Mercury, (acetato-kappaO)(3-(chloromethoxy-kappaO)propyl-kappaC)-
EC / List no:
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| CAS no:
1319-86-4
[2,5-dichloro-3,6-dihydroxy-2,5-cyclohexadiene-1,4-dionato(2-)-O1,O6]mercury
EC / List no:
251-672-9
| CAS no:
33770-60-4
2-hydroxy-5-(1,1,3,3-tetramethylbutyl)phenylmercury acetate
EC / List no:
209-534-0
| CAS no:
584-18-9
[μ-[[4,4'-(oxydiethylene) bis(dodecenylsuccinato)](2-)]]diphenyldimercury
EC / List no:
299-418-6
| CAS no:
93882-20-3
Butanoic acid, 4-((((2-methoxypropyl)amino)carbonyl)amino)-4-oxo-, mercury complex
EC / List no:
-
| CAS no:
72-58-2
Bis(acetato-O)[μ-(3',6'-dihydroxy-3-oxospiro[isobenzofuran-1(3H),9'-[9H]xanthene]-2',7'-diyl)]dimercury
EC / List no:
222-673-1
| CAS no:
3570-80-7
[μ-[(oxydiethylene but-2-enedioato)(2-)]]diphenyldimercury
EC / List no:
301-791-8
| CAS no:
94070-92-5
Sodium [3-[[(3-carboxylatopropionamido)carbonyl]amino]-2-methoxypropyl]hydroxymercurate(1-)
EC / List no:
231-532-3
| CAS no:
7620-30-6
Hydrogen [3-[(α-carboxylato-o-anisoyl)amino]-2-hydroxypropyl]hydroxymercurate(1-)
EC / List no:
247-796-8
| CAS no:
26552-50-1
Diphenyl[μ-[(tetrapropenyl)succinato(2-)-O:O']]dimercury
EC / List no:
248-355-2
| CAS no:
27236-65-3
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Acute Tox. 2; Acute Tox. 1; STOT RE 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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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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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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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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F Fungi |
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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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B Bacteria and similar species |
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B Bacteria and similar species |
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F Fungi |
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B Bacteria and similar species |
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21049-39-8
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Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1 |
yes |
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5826-76-6
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Acute Tox. 4 |
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17169-61-8
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Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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P Parasites |
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P Parasites |
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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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B Bacteria and similar species |
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299-45-6
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Acute Tox. 2; Acute Tox. 1 |
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5787-96-2
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Acute Tox. 3; STOT RE 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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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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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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68583-29-9
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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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108-34-9
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Acute Tox. 2; Acute Tox. 1 |
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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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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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8069-76-9
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Acute Tox. 4 |
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yes |
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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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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
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:
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| CAS no:
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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:
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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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