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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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.

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Last updated 19 April 2024. Database contains 4753 unique substances/entries.
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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
butocarboxim (ISO); 3-(methylthio)-2-butanone O-[(methylamino)carbonyl]oxime
252-139-3
34681-10-2
Flam. Liq. 3; Acute Tox. 3; Eye Irrit. 2
Butyl 4-hydroxybenzoate
202-318-7
94-26-8
yes
butyl butyrate
203-656-8
109-21-7
Flam. Liq. 3
butyl chloroformate; chloroformic acid butyl ester
209-750-5
592-34-7
Flam. Liq. 3; Acute Tox. 3; Skin Corr. 1B
butyl formate
209-772-5
592-84-7
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
butyl glycidyl ether; butyl 2,3-epoxypropyl ether
219-376-4
2426-08-6
Flam. Liq. 3; Carc. 2; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Sens. 1
butyl nitrite
208-862-1
544-16-1
Flam. Liq. 2; Acute Tox. 3
butylamine
203-699-2
109-73-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
butyltricyclohexylstannane
230-358-5
7067-44-9
Acute Tox. 4
butyraldehyde
204-646-6
123-72-8
Flam. Liq. 2
butyraldehyde oxime
203-792-8
110-69-0
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
butyric acid
203-532-3
107-92-6
Skin Corr. 1B
butyryl chloride
205-498-5
141-75-3
Flam. Liq. 2; Skin Corr. 1B
C,C'-azodi(formamide)
204-650-8
123-77-3
Resp. Sens. 1
yes
C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC no.202-027-5);C.I. Basic Violet 3; 4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride;[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride; C.I. Basic Violet 3
208-953-6
548-62-9
yes
C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC no.202-027-5);C.I. Basic Violet 3; 4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride;[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride; C.I. Basic Violet 3
208-953-6
548-62-9
Carc. 1B; Acute Tox. 4; Eye Dam. 1
C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC no.202-027-5);C.I. Basic Violet 3; 4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride;[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride; C.I. Basic Violet 3
208-953-6
548-62-9
Carc. 2; Acute Tox. 4; Eye Dam. 1
C.I. Disperse Yellow 3; N-[4-[(2-hydroxy-5-methylphenyl)azo]phenyl]acetamide
220-600-8
2832-40-8
Carc. 2; Skin Sens. 1
C.I. Solvent Yellow 14; 1-phenylazo-2-naphthol
212-668-2
842-07-9
Carc. 2; Muta. 2; Skin Sens. 1
cadmium carbonate
208-168-9
513-78-0
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
cadmium chloride
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cadmium chloride (CdCl2), hydrate (2:5) EC / List no: 640-998-0 | CAS no: 7790-78-5
233-296-7
10108-64-2
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
cadmium cyanide
208-829-1
542-83-6
Acute Tox. 2; Acute Tox. 1; Carc. 2; STOT RE 2
cadmium diformate; cadmiumformate
224-729-0
4464-23-7
Acute Tox. 3; Carc. 2; STOT RE 2
cadmium fluoride
232-222-0
7790-79-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
cadmium hydroxide; cadmium dihydroxide
244-168-5
21041-95-2
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
cadmium iodide
232-223-6
7790-80-9
Acute Tox. 3; Carc. 2; STOT RE 2
cadmium nitrate; cadmium dinitrate
233-710-6
10325-94-7
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
cadmium oxide (non-pyrophoric)
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Monteponite (CdO) EC / List no: - | CAS no: 12139-21-8
215-146-2
1306-19-0
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
yes
Cadmium sulphate;cadmium sulphate
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Sulfuric acid, cadmium salt (1:1), hydrate EC / List no: 626-360-4 | CAS no: 15244-35-6
Sulfuric acid, cadmium salt, hydrate (3:3:8) EC / List no: 616-572-5 | CAS no: 7790-84-3
233-331-6
10124-36-4;31119-53-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
Cadmium sulphate;cadmium sulphate
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Sulfuric acid, cadmium salt (1:1), hydrate EC / List no: 626-360-4 | CAS no: 15244-35-6
Sulfuric acid, cadmium salt, hydrate (3:3:8) EC / List no: 616-572-5 | CAS no: 7790-84-3
233-331-6
10124-36-4;31119-53-6
yes
cadmium sulphide
215-147-8
1306-23-6
Carc. 1B; Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4
yes
Cadmium;cadmium (non-pyrophoric);cadmium (pyrophoric)
231-152-8
7440-43-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
Cadmium;cadmium (non-pyrophoric);cadmium (pyrophoric)
231-152-8
7440-43-9
yes
Cadmium;cadmium (non-pyrophoric);cadmium (pyrophoric)
231-152-8
7440-43-9
Pyr. Sol. 1; Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
cadmiumhexafluorosilicate(2-); cadmium fluorosilica
241-084-0
17010-21-8
Acute Tox. 3; Carc. 2; STOT RE 2
caffeine
200-362-1
58-08-2
Acute Tox. 4
calcium
231-179-5
7440-70-2
Water-react. 2
Calcium arsenate
231-904-5
7778-44-1
yes
calcium carbide
200-848-3
75-20-7
Water-react. 1
calcium chloride
233-140-8
10043-52-4
Eye Irrit. 2
calcium chromate
237-366-8
13765-19-0
Carc. 1B; Acute Tox. 4
calcium cyanamide
205-861-8
156-62-7
Acute Tox. 4; STOT SE 3; Eye Dam. 1
calcium cyanide
209-740-0
592-01-8
Acute Tox. 2
calcium hydride
232-189-2
7789-78-8
Water-react. 1
calcium hypochlorite
231-908-7
7778-54-3
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1B
calcium phosphide; tricalcium diphosphide
215-142-0
1305-99-3
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1; Eye Dam. 1
calcium polysulphides
215-709-2
1344-81-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
calcium sulphide
243-873-5
20548-54-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
camphechlor (ISO); toxaphene
232-283-3
8001-35-2
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
captafol (ISO);1,2,3,6-tetrahydro-N-(1,1,2,2- tetrachloroethylthio)phthalimide
219-363-3
2425-06-1
Carc. 1B; Skin Sens. 1
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