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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 03 May 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
chlorine
231-959-5
7782-50-5
Ox. Gas 1; Press. Gas; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
chloro(3-(3-chloro-4-fluorophenyl)propyl)dimethylsilane
SILAN MCS
410-270-5
770722-46-8
Skin Corr. 1A
chloroacetic acid
201-178-4
79-11-8
Acute Tox. 3; Skin Corr. 1B
chloroacetyl chloride
201-171-6
79-04-9
Acute Tox. 3; STOT RE 1; Skin Corr. 1A
chloroethane
200-830-5
75-00-3
Flam. Gas 1; Press. Gas; Carc. 2
chloromethane; methyl chloride
200-817-4
74-87-3
Flam. Gas 1; Press. Gas; Carc. 2; STOT RE 2
chlorosulphonic acid
232-234-6
7790-94-5
Skin Corr. 1A; STOT SE 3
Chromic acid
231-801-5
7738-94-5
yes
chrysoidine acetate; 4-(phenylazo)benzene-1,3-diamine acetate
279-116-0
79234-33-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
chrysoidine monoacetate; 4-(phenylazo)benzene-1,3-diamine monoacetate
278-290-5
75660-25-2
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
cis-1-amino-2,3-dihydro-1H-inden-2-ol
422-660-2
7480-35-5
Eye Dam. 1; Skin Sens. 1
cis-2-methylcyclohexanol
231-187-9
7443-70-1
Acute Tox. 4
cobalt
231-158-0
7440-48-4
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
cobalt di(acetate)
200-755-8
71-48-7
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
cobalt dichloride
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
copper chloride; copper (I) chloride; cuprous chloride
231-842-9
7758-89-6
Acute Tox. 4
copper flakes (coated with aliphatic acid)
231-159-6
7440-50-8
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
copper sulphate
231-847-6
7758-98-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
copper sulphate pentahydrate
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
Creosote oil, high-boiling distillate; Wash Oil [The high-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillates, removed. It is crystal free at approximately 5 °C (41°F).]
The high-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillates, removed. It is crystal free at approximately 5°C (41°F).
274-565-9
70321-79-8
Carc. 1B
Creosote oil, low-boiling distillate; Wash Oil [he low-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal, which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillate, removed. It is crystal free at approximately 38 o C (100 oF).]
The low-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal, which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillate, removed. It is crystal free at approximately 38°C (100°F).
274-566-4
70321-80-1
Carc. 1B
crotoxyphos (ISO); 1-phenylethyl 3-(dimethoxyphosphinyloxy) isocrotonate
231-720-5
7700-17-6
Acute Tox. 3
cyclopropane
200-847-8
75-19-4
Flam. Gas 1; Press. Gas
dalapon; 2,2-dichloropropionic acid
200-923-0
75-99-0
Skin Irrit. 2; Eye Dam. 1
di-n-octylaluminium iodide
DNOAI
408-190-0
7585-14-0
Pyr. Liq. 1; Skin Corr. 1B
diammonium nickel hexacyanoferrate
-
74195-78-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
diammonium peroxodisulphate; ammonium persulphate
231-786-5
7727-54-0
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
dibromomethane
200-824-2
74-95-3
Acute Tox. 4
dibutyltin dilaurate; dibutyl[bis(dodecanoyloxy)] stannane
201-039-8
77-58-7
Muta. 2; Repr. 1B; STOT RE 1
dibutyltin hydrogen borate
DBB
401-040-5
75113-37-0
Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
dichloro-(3-(3-chloro-4-fluorophenyl)propyl)methylsilane
SILAN DCS
407-180-3
770722-36-6
Skin Corr. 1A
dichloroacetic acid
201-207-0
79-43-6
Skin Corr. 1A
dichloroacetyl chloride
201-199-9
79-36-7
Skin Corr. 1A
dichloroacetylene
620-404-6
7572-29-4
Unst. Expl.; Carc. 2; STOT RE 2
dichloromethane; methylene chloride
200-838-9
75-09-2
Carc. 2
diclobutrazole (ISO);(R*, R*)-(±)-β-[(2,4-dichlorop henyl)methyl]-α-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol; (2RS, 3RS)-1-(2,4-dichlorophenyl)-4,4-dimethyl-2- (1H—1,2,4-triazol-1yl)pentan-3-ol
620-436-0
75736-33-3
Eye Irrit. 2
didecyldimethylammonium chloride
230-525-2
7173-51-5
Acute Tox. 4; Skin Corr. 1B
diethanolamine perfluorooctane sulfonate
274-460-8
70225-14-8
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
diethylmethoxyborane
425-380-9
7397-46-8
Pyr. Liq. 1; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
digitoxin
200-760-5
71-63-6
Acute Tox. 3; STOT RE 2
diisohexyl phthalate
276-090-2
71850-09-4
Repr. 1B
yes
dimethyl sulphate
201-058-1
77-78-1
Carc. 1B; Muta. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
dimethylcarbamoyl chloride
201-208-6
79-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
dimethyldichlorosilane
200-901-0
75-78-5
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
dimethyltin dichloride
212-039-2
753-73-1
Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Corr. 1B
diniconazole (ISO);(E)-β-[(2,4-dichlorophenyl)methylene]-α-(1,1-dimethylethyl)-1H—1,2,4-triazol-1- ethanol;(E)-(RS)-1-(2,4-dichlorophenyl)-4,4-dimethyl-2-(1H—1,2,4- triazol-1-yl)pent-1-en-3-ol
617-485-5
76714-88-0
Acute Tox. 4
dioxathion (ISO); 1,4-dioxan-2,3-diyl-O,O,O',O'-tetraethyl di(phosphorodithioate)
201-107-7
78-34-2
Acute Tox. 2; Acute Tox. 3
diphenoxymethylenecyanamide
427-300-8
79463-77-7
Eye Dam. 1
diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide
278-355-8
75980-60-8
Repr. 2
dipotassium peroxodisulphate; potassium persulphate
231-781-8
7727-21-1
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
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