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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
1,2,3,4,5,6-hexachlorcyclohexanes with the exception of those specified elsewhere in this Annex
210-168-9
608-73-1
Carc. 2; Acute Tox. 3; Acute Tox. 4
1,2,3,4-tetrahydro-1-naphthyl hydroperoxide
212-230-0
771-29-9
Org. Perox. D; Acute Tox. 4; Skin Corr. 1B
1,2,3,4-tetrahydro-6-nitro-quinoxaline
RO 1173
414-270-6
41959-35-7
Acute Tox. 4
1,2,3,4-tetrahydronaphthalene
204-340-2
119-64-2
Eye Irrit. 2; Skin Irrit. 2
1,2,3,4-tetranitrocarbazole
-
6202-15-9
Expl. 1.1; Acute Tox. 4
1,2,3,6-tetrahydro-3,6-methanophthalic anhydride
212-557-9
826-62-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3,6-tetrahydro-3-methylphthalic anhydride
226-247-6
5333-84-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3,6-tetrahydro-4-methylphthalic anhydride
222-323-8
3425-89-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3,6-tetrahydromethylphthalic anhydride
247-830-1
26590-20-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3,6-tetrahydrophthalic anhydride
201-605-4
85-43-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3-trichloropropane
202-486-1
96-18-4
Carc. 1B; Repr. 1B; Acute Tox. 4
yes
1,2,4-triazole
206-022-9
288-88-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
1,2,4-trichlorobenzene
204-428-0
120-82-1
Acute Tox. 4; Skin Irrit. 2
1,2,4-trimethylbenzene
202-436-9
95-63-6
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
1,2,5,6,9,10-hexabromocyclododecane
221-695-9
3194-55-6
Repr. 2; Lact.
yes
1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters
271-094-0
68515-51-5
yes
1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear
271-093-5
68515-50-4
Repr. 1B
yes
1,2-benzenedicarboxylic acid, dipentylester, branched and linear
284-032-2
84777-06-0
Repr. 1B
yes
1,2-Benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters
272-013-1
68648-93-1
yes
1,2-benzenedicarboxylic acid; di-C6-8-branched alkylesters, C7-rich
276-158-1
71888-89-6
Repr. 1B
yes
1,2-benzenedicarboxylic acid; di-C7-11-branched and linear alkylesters
271-084-6
68515-42-4
Repr. 1B
yes
1,2-benzisothiazol-3(2H)-one;1,2-benzisothiazolin-3-one
220-120-9
2634-33-5
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
1,2-bis(2-methoxyethoxy)ethane; TEGDME; triethylene glycol dimethyl ether; triglyme
203-977-3
112-49-2
Repr. 1B
yes
1,2-bis[4-fluoro-6-{4-sulfo-5-(2-(4-sulfonaphtalene-3-ylazo)-1-hydroxy-3,6-disulfo-8-aminonaphthalene-7-ylazo)phenylamino}-1,3,5-triazin-2ylamino]ethane; x-sodium, y-potassium salts x = 7,755 y =0,245
REACTIVE NAVY DER 7678
417-610-1
155522-09-1
Skin Sens. 1
1,2-diacetoxybut-3-ene
3,4-DIACETOXY-1-BUTENE
421-720-5
18085-02-4
Acute Tox. 4
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