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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 26 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
cinidon ethyl (ISO); ethyl (Z)-2-chloro-3-[2-chloro-5-(cyclohex-1-ene-1,2-dicarboximido)phenyl]acrylate
604-318-6
142891-20-1
Carc. 2; Skin Sens. 1
cis-1,2,3,6-tetrahydro-4-methylphthalic anhydride
216-906-6
1694-82-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
cis-1-(3-(4-fluorophenoxy)propyl)-3-methoxy-4-piperidinamine
425-080-8
104860-26-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
cis-cyclohexane-1,2-dicarboxylicanhydride
236-086-3
13149-00-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
cis-dichloroethylene
205-859-7
156-59-2
Flam. Liq. 2; Acute Tox. 4
citric acid, ammonium nickel salt
242-161-1
18283-82-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
clodinafop-propargyl (ISO)
600-662-6
105512-06-9
Acute Tox. 4; STOT RE 2; Skin Sens. 1
clopyralid (ISO); 3,6-dichloropyridine-2-carboxylic acid
216-935-4
1702-17-6
Eye Dam. 1
clorofene; chlorophene; 2-benzyl-4-chlorophenol
204-385-8
120-32-1
Carc. 2; Repr. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1; Eye Dam. 1; STOT RE 2
cobalt dinitrate
233-402-1
10141-05-6
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
cobalt lithium nickel oxide
442-750-5
113066-89-0
Carc. 1A; Acute Tox. 2; STOT RE 1; Skin Sens. 1
cobalt nickel oxide
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
cobalt oxide
215-154-6
1307-96-6
Acute Tox. 4; Skin Sens. 1
cobalt sulfate
233-334-2
10124-43-3
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
cobalt sulfide
215-273-3
1317-42-6
Skin Sens. 1
copper(II) carbonate-copper(II) hydroxide (1:1)
235-113-6
12069-69-1
Acute Tox. 4; Eye Irrit. 2
coriandrol; (S)-3,7-dimethyl-1,6-octadien-3-ol; d-linalool
204-810-7
126-90-9
Skin Sens. 1B
coumafuryl (ISO); fumarin; (RS)-3-(1-(2-furyl)-3-oxobutyl)4-hydroxycoumarin; 4-hydroxy-3-[3-oxo-1-(2-furyl)butyl]coumarin
204-195-5
117-52-2
Acute Tox. 3; STOT RE 1
cyanofenphos (ISO); O-4-cyanophenyl O-ethyl phenylphosphonothioate
620-377-0
13067-93-1
Acute Tox. 3; STOT SE 1; Acute Tox. 4; Eye Irrit. 2
cyclanilide (ISO); 1-(2,4-dichloroanilinocarbonyl)cyclopropanecarboxylic acid
CSDCA
419-150-7
113136-77-9
Acute Tox. 4
cyclohexane
203-806-2
110-82-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
cyclohexanol
203-630-6
108-93-0
Acute Tox. 4; STOT SE 3; Skin Irrit. 2
cyclohexanone
203-631-1
108-94-1
Flam. Liq. 3; Acute Tox. 4
cyclohexanone, peroxide [> 91 % solution];cyclohexanone, peroxide [≤ 91 % solution]
235-527-7
12262-58-7
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
cyclohexanone, peroxide [> 91 % solution];cyclohexanone, peroxide [≤ 91 % solution]
235-527-7
12262-58-7
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
cyclohexylamine
203-629-0
108-91-8
Flam. Liq. 3; Repr. 2; Acute Tox. 4; Skin Corr. 1B
cyclohexyldimethoxymethylsilane
CHMMS; CHMS; DYNASYLAN 9407; Z-6187
402-140-1
17865-32-6
Skin Irrit. 2
cyclopentanone
204-435-9
120-92-3
Flam. Liq. 3; Eye Irrit. 2; Skin Irrit. 2
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
cyhexatin (ISO); hydroxytricyclohexylstannane; tri(cyclohexyl)tin hydroxide
236-049-1
13121-70-5
Acute Tox. 4
cyprodinil (ISO); 4-cyclopropyl-6-methyl-N-phenylpyrimidin-2-amine
601-785-8
121552-61-2
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
decarbofuran (ISO); 2,3-dihydro-2-methylbenzofuran-7-yl methylcarbamate
-
1563-67-3
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-methylsulphon(ISO); S-2-ethylsulphonylethyl dimethyl phosphorothioate
241-109-5
17040-19-6
Acute Tox. 3; Acute Tox. 4
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-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-pentyl phthalate
205-017-9
131-18-0
Repr. 1B
yes
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
dialuminium nickel tetraoxide
234-454-8
12004-35-2
Carc. 1A; STOT RE 1; Skin Sens. 1
diamminediisocyanatozinc
GENIPLEX A
401-610-3
122012-52-6
Acute Tox. 4; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
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