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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 19 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
cycloxydim (ISO); 2-(N-ethoxybutanimidoyl)-3-hydroxy-5-(tetrahydro-2H-thiopyran-3-yl)cyclohex-2-en-1-one
405-230-9
101205-02-1
Repr. 2
cyflumetofen (ISO); 2-methoxyethyl (RS)-2-(4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoro-o-tolyl)propionate
642-974-5
400882-07-7
Carc. 2; Skin Sens. 1A
cyfluthrin (ISO); α-cyano-4-fluoro-3-phenoxybenzyl-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate;α-cyano-4-fluoro-3-phenoxybenzyl-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate; beta-cyfluthrin
269-855-7
68359-37-5
Acute Tox. 2; Acute Tox. 3
cyfluthrin (ISO); α-cyano-4-fluoro-3-phenoxybenzyl-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate;α-cyano-4-fluoro-3-phenoxybenzyl-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate; beta-cyfluthrin
269-855-7
68359-37-5
Acute Tox. 2
cyhexatin (ISO); hydroxytricyclohexylstannane; tri(cyclohexyl)tin hydroxide
236-049-1
13121-70-5
Acute Tox. 4
cymoxanil (ISO); 2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide
261-043-0
57966-95-7
Repr. 2; Acute Tox. 4; STOT RE 2; 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
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
cyproconazole (ISO); (2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl) butan-2-ol
619-020-1
94361-06-5
Repr. 1B; Acute Tox. 3; STOT RE 2
cyprodinil (ISO); 4-cyclopropyl-6-methyl-N-phenylpyrimidin-2-amine
601-785-8
121552-61-2
Skin Sens. 1
cyprofuram (ISO); N-(3-chlorophenyl)-N-(tetrahydro-2-oxo-3-furyl)cyclopropanecarboxamide
274-050-9
69581-33-5
Acute Tox. 3; Acute Tox. 4
Cytomegalovirus
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
D, L-(N,N-diethyl-2-hydroxy-2-phenylacetamide)
DEM
408-120-9
65197-96-8
Acute Tox. 4; Eye Dam. 1
d-carvone; (5S)-2-methyl-5- (prop-1-en-2-yl)cyclohex-2-en- 1-one
218-827-2
2244-16-8
Skin Sens. 1
D-erythro-hexanoic acid 2,4-dideoxy-3,5-O-(1-methylethylidene)-1,1-dimethylethylester; tert-butyl 2-[(4R, 6S)-6-(hydroxymethyl)-2,2-dimethyl-1,3-dioxan-4-yl]acetate
432-960-5
124655-09-0
Acute Tox. 4
dalapon-sodium; sodium 2,2-dichloropropionate
204-828-5
127-20-8
Skin Irrit. 2; Eye Dam. 1
dalapon; 2,2-dichloropropionic acid
200-923-0
75-99-0
Skin Irrit. 2; Eye Dam. 1
dapsone; 4,4'-diamino diphenyl sulfone
201-248-4
80-08-0
Acute Tox. 4
dazomet (ISO);tetrahydro-3,5-dimethyl-1,3,5- thiadiazine-2-thione
208-576-7
533-74-4
Acute Tox. 4; Eye Irrit. 2
DDT (ISO); clofenotane (INN); dicophane;1,1,1-trichloro-2,2-bis(4-chlorophenyl)ethane; dichlorodiphenyltrichloroethane
200-024-3
50-29-3
Carc. 2; Acute Tox. 3; STOT RE 1
Decamethylcyclopentasiloxane; D5
208-764-9
541-02-6
yes
decanoic acid
206-376-4
334-48-5
Skin Irrit. 2; Eye Irrit. 2
decarbofuran (ISO); 2,3-dihydro-2-methylbenzofuran-7-yl methylcarbamate
-
1563-67-3
Acute Tox. 3
deltamethrin (ISO); (S)-α-cyano-3-phenoxybenzyl(1R, 3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylate
258-256-6
52918-63-5
Acute Tox. 3
demephion-O (ISO); O, O-dimethyl O-2-methylthioethyl phosphorothioate
211-666-9
682-80-4
Acute Tox. 2; Acute Tox. 3
demephion-S (ISO); O, O-dimethyl S-2-methylthioethyl phosphorothioate
219-971-9
2587-90-8
Acute Tox. 2; Acute Tox. 3
demeton
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2
demeton-O (ISO); O,O-diethyl-O-2-ethylthioethyl phosphorothioate
206-053-8
298-03-3
Acute Tox. 1; Acute Tox. 2
demeton-O-methyl (ISO); O-2-ethylthioethyl O,O-dimethyl phosphorothioate
212-758-1
867-27-6
Acute Tox. 3
demeton-S (ISO); diethyl-S-2-ethylthioethyl phosphorothioate
204-801-8
126-75-0
Acute Tox. 1; Acute Tox. 2
demeton-S-methyl (ISO); S-2-ethylthioethyl dimethyl phosphorothioate
213-052-6
919-86-8
Acute Tox. 3
demeton-S-methylsulphon(ISO); S-2-ethylsulphonylethyl dimethyl phosphorothioate
241-109-5
17040-19-6
Acute Tox. 3; Acute Tox. 4
Dengue virus type 1-4
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
desmetryne (ISO);6-isopropylamino-2-methylamino-4-methylthio-1,3,5- triazine
213-800-1
1014-69-3
Acute Tox. 4
di(benzothiazol-2-yl) disulphide
204-424-9
120-78-5
Skin Sens. 1
di(tetramethylammonium)(29H,31H-phthalocyanin-N29,N30,N31,N32)disulfonamide disulfonate, cuprate(2-)complex, derivates
DIRECT BLUE 199
416-180-2
12222-04-7
Acute Tox. 4; STOT RE 2
di-allate (ISO); S-(2,3-dichloroallyl)-N,N-diisopropylthiocarbamate
218-961-1
2303-16-4
Carc. 2; Acute Tox. 4
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
di-methylamine;di-methylamine ... %
204-697-4
124-40-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
di-methylamine;di-methylamine ... %
204-697-4
124-40-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
di-n-butyl ether; dibutyl ether
205-575-3
142-96-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
di-n-butylamine
203-921-8
111-92-2
Flam. Liq. 3; Acute Tox. 4
di-n-octylaluminium iodide
DNOAI
408-190-0
7585-14-0
Pyr. Liq. 1; Skin Corr. 1B
di-n-pentyl phthalate
205-017-9
131-18-0
Repr. 1B
yes
di-sec-butylamine
210-937-9
626-23-3
Flam. Liq. 3; Acute Tox. 4
di-tert-(C12-14)-alkylammonium 2-benzothiazolylthiosuccinate
CM 26-137
406-052-4
125078-60-6
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
di-tert-butyl peroxide
203-733-6
110-05-4
Org. Perox. E; Flam. Liq. 2; Muta. 2
dialifos (ISO); 2-chloro-1-phthalimidoethyl O,O-diethyl phosphorodithioate
233-689-3
10311-84-9
Acute Tox. 2; Acute Tox. 3
diallyl phthalate
205-016-3
131-17-9
Acute Tox. 4
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