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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
cinerin I; 3-(but-2-enyl)-2-methyl-4- oxocyclopent-2-enyl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
246-948-0
25402-06-6
Acute Tox. 4
cinerin II; 3-(but-2-enyl)-2-methyl-4- oxocyclopent-2-enyl 2,2-dimethyl-3-(3-methoxy-2-methyl-3-oxoprop-1-enyl)cyclopropanecarboxylate
204-454-2
121-20-0
Acute Tox. 4
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
cinmethylin (ISO); exo-(±)-1-methyl-2-(2-methylbenzyloxy)-4-isopropyl-7-oxabicyclo(2.2.1)heptane
ARGOLD; CINMETHYLIN; WL 95481
402-410-9
87818-31-3
Acute Tox. 4
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-1,2,3,6-tetrahydrophthalicanhydride
213-308-7
935-79-5
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-1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride
426-020-3
51229-78-8
Flam. Sol. 2; Repr. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
cis-1-(3-chloropropyl)-2,6-dimethyl-piperidin hydrochloride
PD 133602-2
417-430-3
63645-17-0
Acute Tox. 3; STOT RE 2; Skin Sens. 1
cis-1-amino-2,3-dihydro-1H-inden-2-ol
422-660-2
7480-35-5
Eye Dam. 1; Skin Sens. 1
cis-2-methylcyclohexanol
231-187-9
7443-70-1
Acute Tox. 4
cis-dichloroethylene
205-859-7
156-59-2
Flam. Liq. 2; Acute Tox. 4
citral
226-394-6
5392-40-5
Skin Irrit. 2; Skin Sens. 1
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
citric acid, nickel salt
245-119-0
22605-92-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Cladophialophora bantiana
-
-
F Fungi
Clarified oils (petroleum), catalytic cracked; Heavy Fuel oil [A complex combination of hydrocarbons produced as the residual fraction from distillation of the products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4-to 6-membered condensed ring aromatic hydrocarbons.]
A complex combination of hydrocarbons produced as the residual fraction from distillation of the products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-064-6
64741-62-4
Carc. 1B
Clarified oils (petroleum), hydrodesulfurized catalytic cracked; Heavy Fuel oil [A complex combination of hydrocarbons obtained by treating catalytic cracked clarified oil with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350 °C (662 °F). This stream is likely to contain 5 wt. % or more of 4-to 6-membered condensed ring aromatic hydrocarbons.]
A complex combination of hydrocarbons obtained by treating catalytic cracked clarified oil with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
269-782-0
68333-26-6
Carc. 1B
clethodim (ISO); (5RS)-2-{(1EZ)-1-[(2E)-3-chloroallyloxyimino]propyl}-5-[(2RS)-2-(ethylthio)propyl]-3-hydroxycyclohex-2-en-1-one
619-396-7
99129-21-2
Acute Tox. 4; Skin Sens. 1
clodinafop-propargyl (ISO)
600-662-6
105512-06-9
Acute Tox. 4; STOT RE 2; Skin Sens. 1
Clonorchis sinensis
-
-
P Parasites
Clonorchisviverrini
-
-
P Parasites
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
Clostridium botulinum
-
-
B Bacteria and similar species
Clostridium perfringens
-
-
B Bacteria and similar species
Clostridium spp.
-
-
B Bacteria and similar species
Clostridium tetani
-
-
B Bacteria and similar species
clothianidin (ISO); 3-[(2-chloro-1,3-thiazol-5-yl)methyl]-2-methyl-1-nitroguanidine
433-460-1
210880-92-5
Acute Tox. 4
Coal liquids, liq. solvent extn. [The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.]
The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.
302-683-3
94114-48-4
Carc. 1B
Coal liquids, liq. solvent extn. soln. [The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydro-genated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.]
The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydrogenated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.
302-682-8
94114-47-3
Carc. 1B
cobalt
231-158-0
7440-48-4
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
cobalt dimolybdenum nickel octaoxide
268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
cobalt lithium nickel oxide
442-750-5
113066-89-0
Carc. 1A; Acute Tox. 2; STOT RE 1; Skin Sens. 1
cobalt nickel dioxide
261-346-8
58591-45-0
Carc. 1A; STOT RE 1; Skin Sens. 1
cobalt nickel gray periclase; C.I. Pigment Black 25; C.I. 77332
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77332.
269-051-6
68186-89-0
Carc. 1A; 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 sulfide
215-273-3
1317-42-6
Skin Sens. 1
Coccidioides inunitis
-
-
F Fungi
colchicine
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
colecalciferol; cholecalciferol; Vitamin D3
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
Coltivirus
-
-
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.
complex of cobalt(III)-bis(N-phenyl-4-(5-ethylsulfonyl-2-hydroxyphenylazo)-3-hydroxynaphthylamide), hydrated(n H2O,2
SUBSTANCE S171393
427-390-9
-
Skin Sens. 1
condensation product of: 3-(7-carboxyhept-1-yl)-6-hexyl-4-cyclohexene-1,2-dicarboxylic acid with polyamines (primarily; amino-ethyl-piperazine and triethylenetetramine)
INDULIN MQK-1M
413-770-1
-
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Confidential or not yet assessed substance
Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.
-
-
STOT RE 2
constitutional isomers of penta-O-allyl-β-D-fructofuranosyl-α-D-glucopyranoside; constitutional isomers of hexa-O-allyl-β-D-fructofuranosyl-α-D-glucopyranoside; constitutional isomers of hepta-O-allyl-β-D-fructofuransoyl-α-D-glucopyranoside
ALLYL SUCROSE
419-640-0
68784-14-5
Acute Tox. 4
copper chloride; copper (I) chloride; cuprous chloride
231-842-9
7758-89-6
Acute Tox. 4
copper dihydroxide; copper(II) hydroxide
243-815-9
20427-59-2
Acute Tox. 2; Acute Tox. 4; Eye Dam. 1
copper flakes (coated with aliphatic acid)
231-159-6
7440-50-8
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
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