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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 16 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
1,2-dichloropropane; propylene dichloride
201-152-2
78-87-5
Flam. Liq. 2; Carc. 1B; Acute Tox. 4
1,2-diethoxypropane
1,2-DIETHOXYPROPANE; DIETHOXY-1,2-PROPANE
412-180-1
10221-57-5
Flam. Liq. 2
1,2-dihydro-6-hydroxy-4-methyl-1-[3-(1-methylethoxy)propyl]-2-oxo-3-pyridinecarbonitrile
FAT 92'364/A
411-990-2
68612-94-2
Skin Sens. 1
1,2-dihydroxybenzene; pyrocatechol
204-427-5
120-80-9
Carc. 1B; Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
1,2-dimethoxypropane
EXPERIMENTAL DIETHER MM; HISOLVE MMPOM
404-630-0
7778-85-0
Flam. Liq. 2
1,2-dimethyl-3,5-diphenylpyra zolium methylsulphate; difenzoquat methyl sulfate
256-152-5
43222-48-6
Acute Tox. 4
1,2-dimethyl-3-(1-methylethenyl)cyclopentyl acetate
PLINYL ACETATE
424-070-0
94346-09-5
Skin Irrit. 2
1,2-dimethylhydrazine
-
540-73-8
Carc. 1B; Acute Tox. 3
1,2-dimethylimidazole
217-101-2
1739-84-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
1,2-dinitrobenzene
208-431-8
528-29-0
Acute Tox. 2; Acute Tox. 1; STOT RE 2
1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide
203-437-7
106-87-6
Carc. 2; Acute Tox. 3
1,2-epoxybutane
203-438-2
106-88-7
Flam. Liq. 2; Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
1,3,5-trinitrobenzene
202-752-7
99-35-4
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
1,3,5-trioxan; trioxymethylene
203-812-5
110-88-3
Flam. Sol. 1; Repr. 2; STOT SE 3
1,3-bis(2,3-epoxypropoxy)-2,2-dimethylpropane
241-536-7
17557-23-2
Skin Irrit. 2; Skin Sens. 1
1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene
PERKALINK 900
412-570-1
119462-56-5
STOT RE 2; Eye Dam. 1; Skin Sens. 1
1,3-bis(dimethylcarbamoyl)-imidazolium chloride
420-930-4
135756-61-5
Acute Tox. 4; Eye Dam. 1
1,3-bis(vinylsulfonylacetamido)propane
H-604
428-350-3
93629-90-4
Muta. 2; Eye Dam. 1; Skin Sens. 1
1,3-bis[12-hydroxy-octadecamide-N-methylene]-benzene
423-300-7
911674-82-3
Skin Sens. 1
1,3-bis{6-fluoro-4-[1,5-disulfo-4-(3-aminocarbonyl-1-ethyl-6-hydroxy-4-methyl-pyrid-2-on-5-ylazo)-phenyl-2-ylamino]-1,3,5-triazin-2-ylamino}propane lithium-, sodium salt
JAUNE REACTIF MUB 151
415-100-3
149850-29-3
Skin Sens. 1
1,3-butadiene; buta-1,3-diene
203-450-8
106-99-0
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
1,3-di(prop-2,2-diyl)benzene bis(neodecanoylperoxide)
DIPND-50-AL (META)
420-060-5
117663-11-3
Flam. Liq. 3; Org. Perox. D
1,3-dichlorbenzene
208-792-1
541-73-1
Acute Tox. 4
1,3-dichloro-2-propanol
202-491-9
96-23-1
Carc. 1B; Acute Tox. 3; Acute Tox. 4
1,3-dichloro-4-fluorobenzene
1,3-DICHLOR-4-FLUORBENZOL; B-7
406-160-1
1435-48-9
Acute Tox. 4; STOT RE 2; Skin Irrit. 2
1,3-dichloro-5-ethyl-5-methylimidazolidine-2,4-dione
DCEMH
401-570-7
89415-87-2
Ox. Sol. 1; Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
1,3-dichloropropene
208-826-5
542-75-6
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
1,3-diethoxypropane
DE 3
413-140-6
3459-83-4
Flam. Liq. 3
1,3-dimethyl-1,3-bis(trimethylsilyl)urea
UTMS
414-180-7
10218-17-4
Acute Tox. 4; Skin Irrit. 2
1,3-dinitrobenzene
202-776-8
99-65-0
Acute Tox. 2; Acute Tox. 1; STOT RE 2
1,3-dioxolane
211-463-5
646-06-0
Flam. Liq. 2
1,3-diphenylguanidine
203-002-1
102-06-7
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
1,3-propylene oxide
207-964-3
503-30-0
Flam. Liq. 2; Acute Tox. 4
1,4,5,6,7,7-hexachlorobicyclo [2,2,1]hept-5-ene-2,3-dicarboxylicanhydride chlorendic anhydride
204-077-3
115-27-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
1,4,5,8-tetraaminoanthra; quinone; C.I. Disperse Blue 1
219-603-7
2475-45-8
Carc. 1B; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
1,4,7,10-tetraazacyclododecane
425-450-9
294-90-6
Skin Corr. 1B; Acute Tox. 4
1,4,7,10-tetraazacyclododecane disulfate
AZA-KRONE-DISULFAT; SQ 84,042F
412-080-8
112193-77-8
Acute Tox. 4; STOT SE 3; Eye Dam. 1
1,4,7,10-tetrakis(p-toluensulfonyl)-1,4,7,10-tetraazacyclododecane
AZA-KRONE-TETRATOSYLAT
414-030-0
52667-88-6
Skin Sens. 1
1,4-bis(2,3 epoxypropoxy)butane; butanedioldiglycidyl ether
219-371-7
2425-79-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
1,4-bis[(vinyloxy)methyl]cyclohexane
RAPICURE CHVE
413-370-7
17351-75-6
Skin Sens. 1
1,4-dichloro-2-(1,1,2,3,3,3-hexafluoropropoxy)-5-nitrobenzene
CA 946 A
415-580-4
130841-23-5
Acute Tox. 4; Skin Sens. 1
1,4-dichlorobenzene; p-dichlorobenzene
203-400-5
106-46-7
Carc. 2; Eye Irrit. 2
1,4-dichlorobut-2-ene
212-121-8
764-41-0
Carc. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
1,4-Dicyano-2,3,5,6-tetra-chloro-benzene
TETRACHLOROTEREPHTHALONITRILE
401-550-8
1897-41-2
Skin Sens. 1
1,4-dihydroxy-2,2,6,6-tetramethyl piperidinium-2-hydroxy-1,2,3-propanetricarboxylate
429-370-5
220410-74-2
Acute Tox. 4
1,4-dihydroxybenzene; hydroquinone; quinol
204-617-8
123-31-9
Carc. 2; Muta. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
1,4-dimethylcyclohexane
209-663-2
589-90-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
1,4-dinitrobenzene
202-833-7
100-25-4
Acute Tox. 2; Acute Tox. 1; STOT RE 2
1,4-dioxane
204-661-8
123-91-1
Flam. Liq. 2; Carc. 2; Eye Irrit. 2; STOT SE 3
1,5-naphthylene diisocyanate
221-641-4
3173-72-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
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