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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 01 June 2023. Database contains 4740 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
antimony trioxide
215-175-0
1309-64-4
Carc. 2
Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethylene pyrolysis-derived; Pyrolysis Products [A complex combination of hydrocarbonsobtained from mixed coal tar pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numberspredominantly in the range of C20 through C28 and having a softening pointof 100°C to 220°C (212°F to 428°F) according to DIN 52025.]
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-957-1
101794-75-6
Carc. 1B
Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethylene-polypropylene pyrolysis-derived; Pyrolysis Products [A complex combination hydrocarbons obtained from mixed coal tar pitch-polyethylene-polypropylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100 °C to 220 °C (212°F to 428°F) according to DIN 52025.]
A complex combination hydrocarbons obtained from mixed coal tar pitch-polyethylene-polypropylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-956-6
101794-74-5
Carc. 1B
Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polystyrene pyrolysis-derived; Pyrolysis Products [A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.]
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-958-7
101794-76-7
Carc. 1B
asbestos
601-801-3
12172-73-5
Carc. 1A; STOT RE 1
asbestos
601-649-8
12001-28-4
Carc. 1A; STOT RE 1
asbestos
601-650-3
12001-29-5;132207-32-0
Carc. 1A; STOT RE 1
asbestos
-
132207-32-0
Carc. 1A; STOT RE 1
atrazine (ISO);2-chloro-4-ethylamine-6- isopropylamine-1,3,5-triazine
217-617-8
1912-24-9
STOT RE 2; Skin Sens. 1
azobenzene
203-102-5
103-33-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2
azoxystrobin (ISO); methyl (E)-2-{2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate
603-524-3
131860-33-8
Acute Tox. 3
barban (ISO); 4-chlorbut-2-ynyl N-(3-chlorophenyl)carbamate
202-930-4
101-27-9
Acute Tox. 4; Skin Sens. 1
barium calcium cesium lead samarium strontium bromide chloride fluoride iodide europium doped
431-780-4
199876-46-5
Acute Tox. 4; STOT RE 2
barium chlorate
236-760-7
13477-00-4
Ox. Sol. 1; Acute Tox. 4
barium perchlorate
236-710-4
13465-95-7
Ox. Sol. 1; Acute Tox. 4
barium peroxide
215-128-4
1304-29-6
Ox. Sol. 2; Acute Tox. 4
behenamidopropyl-dimethyl-(dihydroxypropyl) ammonium chloride
LEXQUAT AMG-BEO (CONCENTRATE)
423-420-1
136920-10-0
Eye Dam. 1; Skin Sens. 1
benomyl (ISO);methyl 1-(butylcarbamoyl)benzimidazol-2-ylcarbamate
241-775-7
17804-35-2
Muta. 1B; Repr. 1B; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
bensultap (ISO); 1,3-bis(phenylsulfonylthio)-2-(N,N-dimethylamino)propane
605-769-1
17606-31-4
Acute Tox. 4
benzaldehyde
202-860-4
100-52-7
Acute Tox. 4
benzo[e]pyrene
205-892-7
192-97-2
Carc. 1B
Benzo[ghi]perylene
205-883-8
191-24-2
yes
benzo[rst]pentaphene
205-877-5
189-55-9
Carc. 1B; Muta. 2
benzoic acid, N-tert-butyl-N'-(4-chlorobenzoyl)hydrazide
431-600-4
112226-61-6
Skin Sens. 1
benzonitrile
202-855-7
100-47-0
Acute Tox. 4
benzothiazole-2-thiol
205-736-8
149-30-4
Skin Sens. 1
benzovindiflupyr (ISO); N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide
691-719-4
1072957-71-1
Acute Tox. 3
benzthiazuron (ISO); 1-benzothiazol-2-yl-3-methylurea
217-685-9
1929-88-0
Acute Tox. 4
benzyl alcohol
202-859-9
100-51-6
Acute Tox. 4
benzyl benzoate
204-402-9
120-51-4
Acute Tox. 4
benzyl violet 4B; α-[4-(4-dimethylamino-α-{4-[ethyl(3-sodiosulphonato benzyl)amino] phenyl}benzylidene)cyclohexa-2,5-dienylidene(ethyl)ammonio]toluene-3-sulphonate
216-901-9
1694-09-3
Carc. 2
benzyl(S)-2-[(2'-cyanobiphenyl-4-ylmethyl)pentanoylamino]-3-methylbutyrate
427-470-3
137864-22-3
Acute Tox. 4; Skin Sens. 1
benzyl-2-hydroxydodecyldi; methylammonium benzoate
B 2049
402-610-6
113694-52-3
Skin Corr. 1B; Acute Tox. 4
benzyl-N-(2-(2-methoxyphenoxy)ethyl)amine hydrochloride
BM 96.0258.HCL
428-290-8
120606-08-8
Acute Tox. 4; Eye Dam. 1
benzylamine
202-854-1
100-46-9
Acute Tox. 4; Skin Corr. 1B
benzyldimethylamine
203-149-1
103-83-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
benzyldimethyloctadecylammonium 3-nitrobenzenesulfonate
CA10
405-330-2
124088-59-1
Skin Irrit. 2; Eye Dam. 1
benzyltributylammonium 4-hydroxynaphthalene-1-sulphonate
BONTRON P-51
402-240-5
102561-46-6
Acute Tox. 4
beryllium oxide
215-133-1
1304-56-9
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Beta-hexabromocyclododecane
603-802-4
134237-51-7
yes
bifenazate (ISO); isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinecarboxylate
442-820-5
149877-41-8
STOT RE 2; Skin Sens. 1
bis(1-methylethyl)-dimethoxysilane
EURENOR 5021; PSX 872
421-540-7
18230-61-0
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
bis(2,4,4-trimethylpentyl)dithiophosphonic acid
420-160-9
107667-02-7
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
bis(2,4,6-trinitrophenyl)amine; hexyl
205-037-8
131-73-7
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
bis(2,6-dimethoxybenzoyl)-2,4,4-trimethylpentylphosphinoxide
CGI 403
412-010-6
145052-34-2
Skin Sens. 1
bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme
205-594-7
143-24-8
Repr. 1B
yes
Bis(2-chloroethoxy)methane
203-920-2
111-91-1
Eye Irrit. 2; Skin Irrit. 2
bis(2-chloroethyl) ether
203-870-1
111-44-4
Carc. 2; Acute Tox. 2; Acute Tox. 1
Bis(2-ethylhexyl) fumarate
205-448-2
141-02-6
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
bis(2-ethylhexyl) phthalate; di-(2-ethylhexyl) phthalate; DEHP
204-211-0
117-81-7
Repr. 1B
yes
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