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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 15 May 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
flumetralin (ISO); N-(2-chloro-6-fluorobenzyl)-N-ethyl-α, α,α-trifluoro-2,6-dinitro-p-toluidine
613-108-3
62924-70-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
1,2-diethoxyethane
211-076-1
629-14-1
Flam. Liq. 2; Repr. 1A; Eye Irrit. 2
yes
ethylene dinitrate; ethylene glycol dinitrate
211-063-0
628-96-6
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
mercury difulminate; mercuric fulminate; fulminate of mercury;mercury difulminate; mercuric fulminate; fulminate of mercury [≥ 20 % phlegmatiser]
211-057-8
628-86-4
Unst. Expl.; Acute Tox. 3; STOT RE 2
mercury difulminate; mercuric fulminate; fulminate of mercury;mercury difulminate; mercuric fulminate; fulminate of mercury [≥ 20 % phlegmatiser]
211-057-8
628-86-4
Expl. 1.1; Acute Tox. 3; STOT RE 2
pentyl acetate
211-047-3
628-63-7
Flam. Liq. 3
3-chloropropyl chloroformiate
CHLOROFORMIATE DE CHLORO 3 PROPYLE
425-770-9
628-11-5
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
bis(2,2,6,6-tetramethyl-4-piperidyl) succinate
TINUVIN 780
402-940-0
62782-03-0
Eye Irrit. 2
diethylmercury
211-000-7
627-44-1
Acute Tox. 2; Acute Tox. 1; STOT RE 2
methacrifos (ISO); methyl (E)-3-[(dimethoxyphosphinothioyl)oxy]methacrylate
630-448-8
62610-77-9
Acute Tox. 4; Skin Sens. 1
2-cyclopentylidene cyclopentanol 1,1'-bi(cyclopentyliden)-2-ol
434-270-1
6261-30-9
Skin Irrit. 2; Eye Dam. 1
1-methylbutyl acetate
210-946-8
626-38-0
Flam. Liq. 3
di-sec-butylamine
210-937-9
626-23-3
Flam. Liq. 3; Acute Tox. 4
ethyl nitrate
210-903-3
625-58-1
Unst. Expl.
isopropyl formate
210-901-2
625-55-8
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
methoxyacetic acid
210-894-6
625-45-6
Repr. 1B; Acute Tox. 4; Skin Corr. 1B
yes
2-chloropentane
210-885-7
625-29-6
Flam. Liq. 2; Acute Tox. 4
N, N-diethyl-N',N'-dimethylpropan-1,3-diyl-diamine
DDPD
406-610-7
62478-82-4
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1A
sodium 5-[2-chloro-4-(trifluoromethyl) phenoxy]-2-nitrobenzoate; acifluorfen-sodium
263-560-7
62476-59-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
8,8-dimethyl-7-isopropyl-6,10-dioxaspiro[4.5]decane
OPALAL
424-030-2
62406-73-9
Skin Irrit. 2
dimethyl disulphide
210-871-0
624-92-0
Flam. Liq. 2; Acute Tox. 3; STOT SE 3; STOT SE 1; Eye Irrit. 2; Skin Sens. 1
O-ethylhydroxylamine
ETA; ETA 50 (50 %IGE ZUBEREITUNG); O-ETHYLHYDROXYLAMINE
402-030-3
624-86-2
Flam. Liq. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Sens. 1
methyl isocyanate
210-866-3
624-83-9
Flam. Liq. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; Resp. Sens. 1; Skin Sens. 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
(E)-but-2-ene
210-855-3
624-64-6
Flam. Gas 1; Press. Gas
pentyl propionate
210-852-7
624-54-4
Flam. Liq. 3
2-methylbutyl acetat
210-843-8
624-41-9
Flam. Liq. 3
benzene-1,4-diamine dihydrochloride; p-phenylenediamine dihydrochloride
210-834-9
624-18-0
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
N-methyl-p-toluidine
210-769-6
623-08-5
Acute Tox. 3; STOT RE 2
bis(2-ethylhexyl) dithiodiacetate
DI(2-ETHYLHEXYL)DITHIODIGLYKOLAT; DP 327
404-510-8
62268-47-7
Acute Tox. 4; Skin Sens. 1
Sulfurous acid, lead salt, dibasic
263-467-1
62229-08-7
yes
nitrosodipropylamine
210-698-0
621-64-7
Carc. 1B; Acute Tox. 4
2-amino-6-ethoxy-4-methylamino-1,3,5-triazine
DPX-D-7556
403-580-7
62096-63-3
Acute Tox. 4
Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate
700-242-3
62037-80-3
yes
1,2,3,4-tetranitrocarbazole
-
6202-15-9
Expl. 1.1; Acute Tox. 4
dimethylnitrosoamine; N-nitrosodimethylamine
200-549-8
62-75-9
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
sodium fluoroacetate
200-548-2
62-74-8
Acute Tox. 2; Acute Tox. 1
dichlorvos (ISO); 2,2-dichlorovinyl dimethyl phosphate
200-547-7
62-73-7
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
thiourea; thiocarbamide
200-543-5
62-56-6
Carc. 2; Repr. 2; Acute Tox. 4
thioacetamide
200-541-4
62-55-5
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Aniline
200-539-3
62-53-3
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1
phenylmercury acetate
200-532-5
62-38-4
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
dodecyl 3-amino-4-chlorobenzoate
428-020-9
6195-20-6
Skin Sens. 1
potassium 4-iodo-2-sulfonato-benzoic acid
426-620-5
619297-89-1
Eye Dam. 1
3-ethylhexane
210-621-0
619-99-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,5-dinitrotoluene
210-581-4
619-15-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
(S)-α-hydroxy-3-phenoxy-benzeneacetonitrile
441-070-6
61826-76-4
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
(2-(aminomethyl)phenyl)acetylchloride hydrochloride
X-17-17
417-410-4
61807-67-8
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
3,5-dinitrotoluene
210-566-2
618-85-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
1-phenylethylamine;DL-α-methylbenzylamine
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
1-phenylethylamine;DL-α-methylbenzylamine
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
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