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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 18 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
2-hydroxy-2-methylpropionitrile; 2-cyanopropan-2-ol; acetone cyanohydrin
200-909-4
75-86-5
Acute Tox. 2; Acute Tox. 1
2-hydroxy-3-(2-ethyl-4-methylimidazoyl)propyl neodecanoate
EPIKURE DX 6906
417-350-9
776326-15-9
Skin Irrit. 2; Eye Dam. 1
2-hydroxy-3-[(2-hydroxyethyl)-[2-(1-oxotetradecyl)amino]ethyl]amino]-N,N,N-trimethyl-1-propanammonium chloride
AMINO CATION S-36
414-670-0
141890-30-4
Acute Tox. 4; Eye Dam. 1
2-hydroxyethyl acrylate
212-454-9
818-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
2-hydroxyethyl methacrylate
212-782-2
868-77-9
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-hydroxyethylammonium perbromide
LIQUIBROM 2038
407-440-6
127395-77-1
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
2-hydroxymethyl-9-methyl-6-(1-methylethyl)-1,4-dioxaspiro[4.5]decane
FRESCOLAT MGA
408-200-3
63187-91-7
Skin Irrit. 2; Eye Dam. 1
2-hydroxypropyl methacrylate
213-090-3
923-26-2
Eye Irrit. 2; Skin Sens. 1
2-hydroxypropylacrylate
213-663-8
999-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
2-isobutyl-2-isopropyl-1,3-dimethoxypropane
430-800-9
129228-21-3
Skin Irrit. 2
2-isopropoxyethanol; ethylene glycol monoisopropyl ether
203-685-6
109-59-1
Acute Tox. 4; Eye Irrit. 2
2-isopropyl-2-(1-methylbutyl)-1,3-dimethoxypropane
406-970-5
129228-11-1
Skin Irrit. 2
2-isopropyl-4-(N-methyl)aminomethylthiazole
A-87463.0
414-800-6
154212-60-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
2-isopropyl-5-methylcyclohexyloxycarbonyloxy-2-hydroxypropane
FRESCOLAT MPC
417-420-9
156324-82-2
Eye Irrit. 2
2-methoxy-1-methylethyl acetate
203-603-9
108-65-6
Flam. Liq. 3
2-methoxy-2-methylbutane; tert-amyl methyl ether
213-611-4
994-05-8
Flam. Liq. 2; Acute Tox. 4; STOT SE 3
2-methoxyaniline; o-anisidine
201-963-1
90-04-0
Carc. 1B; Muta. 2; Acute Tox. 3
yes
2-methoxyethanol; ethylene glycol monomethyl ether
203-713-7
109-86-4
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
2-methoxyethyl acetate; methylglycol acetate
203-772-9
110-49-6
Repr. 1B; Acute Tox. 4
yes
2-methoxyethyl acrylate
221-499-3
3121-61-7
Flam. Liq. 3; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1
2-methoxyethylmercury chloride
204-659-7
123-88-6
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
2-methoxypropanol
216-455-5
1589-47-5
Flam. Liq. 3; Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
2-methoxypropyl acetate
274-724-2
70657-70-4
Flam. Liq. 3; Repr. 1B; STOT SE 3
2-methyl-1,2-benzothiazol-3(2H)-one; [MBIT]
695-989-4
2527-66-4
Acute Tox. 4; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
2-methyl-1,5-pentanediamine-1,3-benzenedicarboxylate
433-910-5
145153-52-2
Skin Sens. 1
2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one
ACETOCURE 97; GENOCURE*PMP; IGM 4817; IRGACURE 907; SPEEDCURE 97
400-600-6
71868-10-5
Repr. 1B; Acute Tox. 4
yes
2-methyl-1-pentylpyridinium bromide
ENS 125
402-690-2
148292-41-5
Acute Tox. 4
2-methyl-2-azabicyclo[2.2.1]heptane
THANCAT AN 10
404-810-9
4524-95-2
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
2-methyl-3-(trimethoxysilyl)propyl-2-propenoate hydrolysis product with silica
419-030-4
125804-20-8
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
2-methyl-4-(1,1-dimethylethyl)-6-(1-methyl-pentadecyl)-phenol
CG 31-1919
410-760-9
157661-93-3
Skin Irrit. 2; Skin Sens. 1
2-methyl-4-oxo-3-(penta-2,4- dienyl)cyclopent-2-enyl [1R- [1α[S*(Z)],3β]]-chrysanthemate; pyrethrin I
204-455-8
121-21-1
Acute Tox. 4
2-methyl-4-oxo-3-(penta-2,4- dienyl)cyclopent-2-enyl[1R- [1α[S*(Z)](3β)]]-3-(3-methoxy-2-methyl-3-oxoprop-1-enyl)-2,2- dimethylcyclopropanecar boxylate; pyrethrin II
204-462-6
121-29-9
Acute Tox. 4
2-methyl-4-phenylpentanol
PAMPLEFLEUR
402-770-7
92585-24-5
Skin Sens. 1
2-methyl-5-(1,1,3,3-tetramethylbutyl)hydroquinone
AF-336
400-530-6
723-38-6
Eye Dam. 1; Skin Sens. 1
2-methyl-5-phenylpentanol
ROSAPHEN
405-890-8
25634-93-9
Eye Irrit. 2; Skin Irrit. 2
2-methyl-5-tert-butylthiophenol
444-970-7
7340-90-1
Flam. Liq. 3; Repr. 2; STOT RE 2; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1; STOT SE 3
2-methyl-m-phenylene diisocyanate; toluene-2,4-di-isocyanate
202-039-0
91-08-7
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
2-methyl-m-phenylenediamine; 2,6-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
212-513-9
823-40-5
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
2-methyl-m-phenylenediamine; 2,6-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
212-513-9
823-40-5
Muta. 2; Acute Tox. 4; Skin Sens. 1
2-methyl-p-phenylenediamine sulphate
228-871-4
6369-59-1
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
2-methyl-p-phenylenediamine sulphate
210-431-8
615-50-9
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
2-methyl-p-phenylenediamine; 2,5-toluenediamine
202-442-1
95-70-5
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
2-methylaminoethanol; N-methylethanolamine; N-methyl-2-ethanolamine; N-methyl-2-amino ethanol; 2-(methylamino)ethanol
203-710-0
109-83-1
Acute Tox. 4; Skin Corr. 1B
2-methylaziridine; propyleneimine
200-878-7
75-55-8
Flam. Liq. 2; Carc. 1B; Acute Tox. 2; Acute Tox. 1; Eye Dam. 1
2-methylbutan-2-ol; tert-pentanol
200-908-9
75-85-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
2-methylbutyl acetat
210-843-8
624-41-9
Flam. Liq. 3
2-methylbutyl formate
252-343-2
35073-27-9
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
2-methylbutyl propionate
219-449-0
2438-20-2
Flam. Liq. 3
2-methylcyclohexanol, mixed isomers
209-512-0
583-59-5
Acute Tox. 4
2-methylcyclohexanone
209-513-6
583-60-8
Flam. Liq. 3; Acute Tox. 4
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