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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
(6β)-6,19-epoxyandrost-4-ene-3,17-dione
433-490-3
6563-83-3
Skin Sens. 1
(3β, 5α, 6β)-3-(acetyloxy)-5-bromo-6-hydroxy-androstan-17-one
17-KETOBROMOHYDRINE
419-790-7
4229-69-0
Skin Sens. 1
(2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol; mefentrifluconazole
822-682-6
1417782-03-6
Skin Sens. 1
(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(-3-(diethylammonio)propylamino)1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate
BLUE 10 25 964
407-240-9
159604-94-1
Skin Sens. 1
(1S)-2-methyl-2,5-diazobicyclo[2.2.1]heptanes dihydrobromide
CP-84,203-4; DFX-5S
411-000-9
125224-62-6
Skin Sens. 1
(+/–)-(R*,R*)-6-fluoro-3,4-dihydro-2-oxiranyl-2H-1-benzopyran; 6-fluoro-2-(2-oxiranyl)chromane
419-620-1
-
Skin Sens. 1
thionyl chloride, reaction products with 1,3,4-thiadiazol-2,5-dithiol, tert-nonanethiol andC 12-14-tert-alkylamine
RT 1766A
404-820-3
164637-97-2
Skin Irrit. 2; Skin Sens. 1
sodium 3,5-bis(3-(2,4-di-tert-pentylphenoxy)propylcarbamoyl)benzenesulfonate
AF-365
405-510-0
121216-78-2
Skin Irrit. 2; Skin Sens. 1
reaction product of diphenylamine, phenothiazine, and alkenes, branched (C8-10, C9-rich)
439-540-0
-
Skin Irrit. 2; Skin Sens. 1
reaction product of ammonium molybdate and C12-C24-diethoxylated alkylamine (1:5-1:3)
ADDITIV 104
412-780-3
1380226-46-9
Skin Irrit. 2; Skin Sens. 1
reaction mass of: trans-trans-cyclohexadeca-1,9-diene; cis-trans-cyclohexadeca-1,9-diene
429-620-3
110028-14-3
Skin Irrit. 2; Skin Sens. 1
reaction mass of: 2-chloro-5-sec-tetradecylhydroquinones where sec-tetradecyl = 1-methyltridecyl; 1-ethyldodecyl; 1-propylundecyl; 1-butyldecyl; 1-pentylnonyl; 1-hexyloctyl
AF-376
407-740-7
138427-56-2
Skin Irrit. 2; Skin Sens. 1
reaction mass (ratio not known) of: ammonium 1-C14-C18-alkyloxycarbonyl-2-(3-allyloxy-2-hydroxypropoxycarbonyl)ethane-1-sulfonate; ammonium 2-C14-C18-alkyloxycarbonyl-1-(3-allyloxy-2-hydroxypropoxycarbonyl)ethane-1-sulfonate
LATEMUL S-180 A
410-540-2
116726-92-2
Skin Irrit. 2; Skin Sens. 1
oxirane, mono[(C12-14-alkyloxy)methyl] derivs.
271-846-8
68609-97-2
Skin Irrit. 2; Skin Sens. 1
N-hexadecyl(or octadecyl)-N-hexadecyl (or octadecyl)benzamide
DTBA
401-980-6
-
Skin Irrit. 2; Skin Sens. 1
N, N'-(2,2-dimethylpropylidene)hexamethylenediamine
LUPRAGEN VP 9159
401-660-6
1000-78-8
Skin Irrit. 2; Skin Sens. 1
mixed linear and branched C14-15 alcohols ethoxylated, reaction product with epichlorohydrin
NUPORE G45-10
420-480-9
158570-99-1
Skin Irrit. 2; Skin Sens. 1
isobutyl 3,4-epoxybutyrate
IVAX
401-920-9
100181-71-3
Skin Irrit. 2; Skin Sens. 1
ditalimfos (ISO); O, O-diethyl phthalimidophosphonothioate
225-875-8
5131-24-8
Skin Irrit. 2; Skin Sens. 1
di-L-para-menthene
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
di-L-para-menthene
686-814-2
34363-01-4
Skin Irrit. 2; Skin Sens. 1
cyclohexadeca-1,9-diene
431-730-1
4277-06-9
Skin Irrit. 2; Skin Sens. 1
citral
226-394-6
5392-40-5
Skin Irrit. 2; Skin Sens. 1
alkenes, C12-14, hydroformylation products, distn. residues, C-(hydrogen sulfobutanedioates), disodium salts
435-660-2
243662-67-1
Skin Irrit. 2; Skin Sens. 1
4-methyl-8-methylenetricyclo[3.3.1.13,7]dec-2-yl acetate
PRISMYLATE
406-560-6
122760-85-4
Skin Irrit. 2; Skin Sens. 1
4-methyl-8-methylenetricyclo[3.3.1.1 3,7]decan-2-ol
PRISMANTOL
406-330-5
122760-84-3
Skin Irrit. 2; Skin Sens. 1
3,7-dimethyloctanenitrile
HYPO-LEM
403-620-3
40188-41-8
Skin Irrit. 2; Skin Sens. 1
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-(2,4-dichlorophenyl)-2-(2-propenyl)oxirane
EPO
411-210-0
89544-48-9
Skin Irrit. 2; Skin Sens. 1
2,5,7,7-tetramethyloctanal
LYRISAL
405-690-0
114119-97-0
Skin Irrit. 2; Skin Sens. 1
2,4-dimethyl-6-(1-methyl-pentadecyl)phenol
CG 27-145
411-220-5
134701-20-5
Skin Irrit. 2; Skin Sens. 1
18-methylnonadecyl 2,2-dimethylpropanoate
424-370-1
125496-22-2
Skin Irrit. 2; Skin Sens. 1
1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine
SANDUVOR 3058; SANDUVOR 3058 LIQ.
411-930-5
106917-31-1
Skin Irrit. 2; Skin Sens. 1
1,3-bis(2,3-epoxypropoxy)-2,2-dimethylpropane
241-536-7
17557-23-2
Skin Irrit. 2; Skin Sens. 1
(C16 or C18-n-alkyl)(C16 or C18-n-alkyl)ammonium 2-((C16 or C18-n-alkyl)(C16 or C18-n-alkyl)carbamoyl)benzenesulphonate
OA 8523
402-460-1
-
Skin Irrit. 2; Skin Sens. 1
nonanoic acid
203-931-2
112-05-0
Skin Irrit. 2; Eye Irrit. 2
decanoic acid
206-376-4
334-48-5
Skin Irrit. 2; Eye Irrit. 2
styrene-4-sulfonyl chloride
STYRENE SULPHONYL CHLORIDE
404-770-2
2633-67-2
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
sodium (Z)-3-chloro-3-(4-chlorophenyl)-1-hydroxy-2-propene-1-sulfonate
420-800-7
1379804-37-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of: tetradecanoic acid; poly(1-7)lactate esters of tetradecanoic acid
PRICARE
411-910-6
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of: tetradecanoic acid (42,5-47,5 %); poly(1-7)lactate esters of tetradecanoic acid (52,5-57,5 %)
PRIAZUL MYRISTOYL LACTYLATE; PRICARE MYRISTYL LACTYLATE (1:1.5)
412-580-6
174591-51-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of: dodecanoic acid (35-40 %); poly(1-7)lactate esters of dodecanoic acid (60-65 %)
PRIAZUL LAUROYL LACTYLATE; PRICARE LAURYL LACTYLATE (1:1.5)
412-590-0
58856-63-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of C12-14-tert-alkylammonium diphenyl phosphorothioate and dinonyl sulphide (or disulphide)
X 3761
400-930-0
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of 2-acryloyloxyethyl hydrogen cyclohexane-1,2-dicarboxylate and 2-methacryloyloxyethyl hydrogen cyclohexane-1,2-dicarboxylate
KAYARAD R-825
405-360-6
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
mono[2-(dimethylamino)ethyl]monohydrogen-2-(hexadec-2-enyl)butanedioate and/or mono[2-(dimethylamino)ethyl]monohydrogen-3-(hexadec-2-enyl)butanedioate
Z-22
415-880-5
779343-34-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
methyl 4-bromomethyl-3-methoxybenzoate
BROMBENZOAT; BROMOBENZOATE
410-310-1
70264-94-7
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
fatty acids, C18-unsatd., dimers, reaction products with 1-piperazineethanamine and tall oil
447-880-6
206565-89-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
ethyl 3-hydroxy-5-oxo-3-cyclohexene-1-carboxylate
CA 875 B
414-450-4
88805-65-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
ethyl 2-carboxy-3-(2-thienyl)propionate
SB-201999
415-680-8
143468-96-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
6-fluoro-2-methyl-3-(4-methylthiobenzyl)indene
IN-4; INDENE IN-4
405-410-7
41201-60-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
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