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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 24 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
2,4-diamino-5-methoxymethylpyrimidine
DAMP
410-330-0
54236-98-5
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
2,6-diamino-3,5-diethyltoluene; 4,6-diethyl-2-methyl-1,3-benzenediamine
218-255-3
2095-01-4
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
diethylmethylbenzenediamine
270-877-4
68479-98-1
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
N-carboxymethyliminobis(ethylenenitrilo)tetra (acetic acid)
200-652-8
67-43-6
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
pentapotassium 2,2',2'',2''',2''''-(ethane-1,2-diylnitrilo)pentaacetate
404-290-3
7216-95-7
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
thiram (ISO); tetramethylthiuram disulphide
205-286-2
137-26-8
Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
4,4'-methylenebis(N,N'-dimethylcyclohexanamine)
LUPRAGEN VP 9199 X
412-840-9
13474-64-1
Acute Tox. 4; STOT RE 2; Skin Corr. 1A
hydroxydisulfito platinum(II)acid
423-310-1
61420-92-6
Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
1,1,3,3-tetrabutyl-1,3-ditinoxydicaprylate
D 28-283
419-430-9
56533-00-7
Acute Tox. 4; STOT RE 2; Skin Corr. 1B
reaction mass of: dodecyl N-(2,2,6,6-tetramethylpiperidin-4-yl)-β-alaninate; tetradecyl N-(2,2,6,6-tetramethylpiperidin-4-yl)-β-alaninate
VP SANDUVOR 3052 LIQUIDE
405-670-1
119530-69-7
Acute Tox. 4; STOT RE 2; Skin Corr. 1B
1,6-bis(3,3-bis((1-methylpentylidenimino)propyl)ureido)hexane
SETALUX EPC 4690
420-190-2
771478-66-1
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
2-bromo-1-(2-furyl)-2-nitroethylene
EF-40
406-110-9
35950-52-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
2-butyl-2-ethyl-1,5-diaminopentane
C11-NEODIAMINE
412-700-7
137605-95-9
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
hydroxyphosphonoacetic acid
DP-3337
405-710-8
23783-26-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
tributyltetradecylphosphonium tetrafluoroborate
D 27-046
413-520-1
125792-14-5
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
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
2-(4-(4-cyano-3-methylisothiazol-5-ylazo)-N-ethyl-3-methylanilino)ethyl acetate
TTP MAGENTA 3
405-480-9
110260-50-9
Acute Tox. 4; STOT RE 2; Skin Irrit. 2
2,2'-iminodiethanol; diethanolamine
203-868-0
111-42-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2,3,4-trifluoroaniline
2,3,4-TRIFLUORANILIN
407-170-9
3862-73-5
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2-(2-(2-hydroxyethoxy)ethyl)-2-aza-bicyclo[2.2.1]heptane
THANCAT AN 20
407-360-1
116230-20-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
4-[3-(diethoxymethylsilylpropoxy)-2,2,6,6-tetramethyl]piperidine
PSL 6
411-400-3
102089-33-8
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2-chloromethyl-3,4-dimethoxypyridinium chloride
B8510-020; CHLORMETHYLPYRIDIN; CHLORMETHYLPYRIDINE; CHLOROMETHYLPYRIDINE
416-440-5
72830-09-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
3-(2-bromopropionoyl)-4,4-dimethyl-1,3-oxazolan-2-one
430-820-8
114341-88-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
tetrabutylammonium 2-amino-6-iodopurinate
424-710-9
156126-48-6
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
1-(3-cyclopentyloxy-4-methoxyphenyl)-4-oxo-cyclohexanecarbonitrile
427-450-4
152630-47-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
2,3-dihydro-2,2-dimethyl-1H-perimidine
424-060-6
6364-17-6
Acute Tox. 4; STOT RE 2; Skin Sens. 1
3-cyano-3,5,5-trimethylcyclohexanone
ISOPHORONENITRILE, IPN
411-490-4
7027-11-4
Acute Tox. 4; STOT RE 2; Skin Sens. 1
amitraz (ISO); N,N-bis(2,4-xylyliminomethyl); methylamine
251-375-4
33089-61-1
Acute Tox. 4; STOT RE 2; Skin Sens. 1
bis(4-hydroxy-N-methylanilinium) sulphate
200-237-1
55-55-0
Acute Tox. 4; STOT RE 2; Skin Sens. 1
clodinafop-propargyl (ISO)
600-662-6
105512-06-9
Acute Tox. 4; STOT RE 2; Skin Sens. 1
diethyl thiophosphoryl (Z)-(2-aminothiazol-4-yl)methoxyimino acetate
DAMA
426-790-0
162208-27-7
Acute Tox. 4; STOT RE 2; Skin Sens. 1
disulfiram; tetraethylthiuramdisulfide
202-607-8
97-77-8
Acute Tox. 4; STOT RE 2; Skin Sens. 1
flufenacet (ISO);N-(4-fluorophenyl)-N-isopropyl-2-(5-trifluoromethyl-[1,3,4]thiadiazol-2-yloxy)acetamide
604-290-5
142459-58-3
Acute Tox. 4; STOT RE 2; Skin Sens. 1
propineb (ISO); polymeric zinc propylenebis(dithiocarbamate)
620-365-5
9016-72-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
tri-allate (ISO); S-2,3,3-trichloroallyl diisopropylthiocarbamate
218-962-7
2303-17-5
Acute Tox. 4; STOT RE 2; Skin Sens. 1
2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (Z)-(1R,3R)-3-(2-cyanoprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate; epsilon-momfluorothrin
-
1065124-65-3
Acute Tox. 4; STOT SE 2
cypermethrin cis/trans +/-40/60; (RS)-α-cyano-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate;cypermethrin cis/trans +/-80/20; (RS)-α-cyano-3-phenoxybenzyl (1RS;3RS; 1RS, 3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate
257-842-9
52315-07-8
Acute Tox. 4; STOT SE 3
methyl 2,5-dichlorobenzoate
220-815-7
2905-69-3
Acute Tox. 4; STOT SE 3
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
4-methyl-N-(methylsulfonyl)benzenesulfonamide
POWDERLINK (R) MTSI
415-040-8
14653-91-9
Acute Tox. 4; STOT SE 3; Eye Dam. 1
calcium cyanamide
205-861-8
156-62-7
Acute Tox. 4; STOT SE 3; Eye Dam. 1
2,4-D (ISO); 2,4-dichlorophenoxyacetic acid
202-361-1
94-75-7
Acute Tox. 4; STOT SE 3; Eye Dam. 1; Skin Sens. 1
hexamethylenediamine
204-679-6
124-09-4
Acute Tox. 4; STOT SE 3; Skin Corr. 1B
cyclohexanol
203-630-6
108-93-0
Acute Tox. 4; STOT SE 3; Skin Irrit. 2
1-naphtol
201-969-4
90-15-3
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
bronopol (INN); 2-bromo-2-nitropropane-1,3-diol
200-143-0
52-51-7
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
sodium 2-biphenylate; 2-phenylphenol, sodium salt
205-055-6
132-27-4
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
phthalic anhydride
201-607-5
85-44-9
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
2,3,5-trimethylhydroquinone
211-838-3
700-13-0
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
cypermethrin cis/trans +/-40/60; (RS)-α-cyano-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate;cypermethrin cis/trans +/-80/20; (RS)-α-cyano-3-phenoxybenzyl (1RS;3RS; 1RS, 3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate
257-842-9
52315-07-8
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
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