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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 23 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
dibutyl phthalate; DBP
201-557-4
84-74-2
Repr. 1B
yes
dibutylbis(pentane-2,4-dionato-O,O')tin
245-152-0
22673-19-4
Repr. 1B; STOT RE 1
yes
dibutyltin dichloride; (DBTC)
211-670-0
683-18-1
Muta. 2; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B
yes
Dichromic acid
236-881-5
13530-68-2
yes
dichromium tris(chromate); chromium III chromate; chromic chromate
246-356-2
24613-89-6
Ox. Sol. 1; Carc. 1B; Skin Corr. 1A; Skin Sens. 1
yes
dicyclohexyl phthalate
201-545-9
84-61-7
Repr. 1B; Skin Sens. 1
yes
diethyl sulphate
200-589-6
64-67-5
Carc. 1B; Muta. 1B; Acute Tox. 4; Skin Corr. 1B
yes
dihexyl phthalate
201-559-5
84-75-3
Repr. 1B
yes
diisobutyl phthalate
201-553-2
84-69-5
Repr. 1B
yes
diisohexyl phthalate
276-090-2
71850-09-4
Repr. 1B
yes
diisopentylphthalate
210-088-4
605-50-5
Repr. 1B
yes
dimethyl sulphate
201-058-1
77-78-1
Carc. 1B; Muta. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
dinoseb (ISO); 6-sec-butyl-2,4-dinitrophenol
201-861-7
88-85-7
Repr. 1B; Acute Tox. 3; Eye Irrit. 2
yes
Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety
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dioctyltin dilaurate; stannane, dioctyl-, bis(coco acyloxy) derivs. EC / List no: - | CAS no: -
Dioctyltin dilaurate EC / List no: 222-883-3 | CAS no: 3648-18-8
Stannane, dioctyl-, bis(coco acyloxy) derivs. EC / List no: 293-901-5 | CAS no: 91648-39-4
799-973-9
-
yes
Dioxobis(stearato)trilead
235-702-8
12578-12-0
yes
disodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate); C.I. Direct Red 28
209-358-4
573-58-0
Carc. 1B; Repr. 2
yes
disodium 4-amino-3-[[4'-[(2,4-diaminophenyl)azo][1,1'-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)naphtalene-2,7-disulphonate; C.I. Direct Black 38
217-710-3
1937-37-7
Carc. 1B; Repr. 2
yes
disodium octaborate anhydrous
234-541-0
12008-41-2
Repr. 1B
yes
disodium tetraborate decahydrate; borax decahydrate
603-411-9
1303-96-4
Repr. 1B
yes
Disodium tetraborate pentahydrate
601-808-1
12179-04-3
Repr. 1B
yes
disodium tetraborate, anhydrous; boric acid, disodium salt
215-540-4
1330-43-4
Repr. 1B
yes
Dodecamethylcyclohexasiloxane; D6
208-762-8
540-97-6
yes
ethylene thiourea; imidazolidine-2-thione; 2-imidazoline-2-thiol
202-506-9
96-45-7
Repr. 1B; Acute Tox. 4
yes
ethylenediamine; 1,2-diaminoethane
203-468-6
107-15-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
Fatty acids, C16-18, lead salts
292-966-7
91031-62-8
yes
Fluoranthene
205-912-4
206-44-0
yes
Formaldehyde, oligomeric reaction products with aniline
500-036-1
25214-70-4
yes
Formaldehyde, reaction products with branched and linear heptylphenol, carbon disulfide and hydrazine
300-298-5
93925-00-9
yes
formamide
200-842-0
75-12-7
Repr. 1B
yes
furan
203-727-3
110-00-9
Flam. Liq. 1; Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2
yes
Gamma-hexabromocyclododecane
603-804-5
134237-52-8
yes
Henicosafluoroundecanoic acid
218-165-4
2058-94-8
yes
Heptacosafluorotetradecanoic acid
206-803-4
376-06-7
yes
hexabromocyclododecane
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gamma-hexabromocyclododecane EC / List no: 603-804-5 | CAS no: 134237-52-8
alpha-hexabromocyclododecane EC / List no: 603-801-9 | CAS no: 134237-50-6
beta-hexabromocyclododecane EC / List no: 603-802-4 | CAS no: 134237-51-7
1,2,5,6,9,10-hexabromocyclodecane EC / List no: 221-695-9 | CAS no: 3194-55-6
Hexabromocyclododecane EC / List no: 247-148-4 | CAS no: 25637-99-4
247-148-4
25637-99-4
Repr. 2; Lact.
yes
hexahydro-1-methylphthalic anhydride
256-356-4
48122-14-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
hexahydro-3-methylphthalicanhydride
260-566-1
57110-29-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
hexahydro-4-methylphthalic anhydride
243-072-0
19438-60-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
hexahydromethylphthalic anhydride
247-094-1
25550-51-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
hydrazine
206-114-9
302-01-2
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
Hydrazine hydrate
616-584-0
7803-57-8
yes
Isomers of 2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propionic acid
-
-
yes
Isononylphenol
234-284-4
11066-49-2
yes
Isononylphenol, ethoxylated
609-346-2
37205-87-1
yes
Lead bis(tetrafluoroborate)
237-486-0
13814-96-5
yes
lead chromate
231-846-0
7758-97-6
Carc. 1B; Repr. 1A; STOT RE 2
yes
lead chromate molybdate sulfate red; C.I. Pigment Red 104 [This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77605.]
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77605.
235-759-9
12656-85-8
Carc. 1B; Repr. 1A; STOT RE 2
yes
Lead cyanamidate
244-073-9
20837-86-9
yes
lead di(acetate)
206-104-4
301-04-2
Repr. 1A; STOT RE 2
yes
Lead diazide; Lead azide;lead diazide; lead azide;lead diazide; lead azide [≥ 20 % phlegmatiser]
236-542-1
13424-46-9
yes
Lead dinitrate
233-245-9
10099-74-8
yes
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