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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 24 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
(1S,2S,5R,6R,9S,10S,13R,14R)-1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.1⁶,⁹.0²,¹³.0⁵,¹⁰]octadeca-7,15-diene
-
135821-03-3
yes
(1S,2S,5S,6S,9R,10R,13R,14R)-1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.1⁶,⁹.0²,¹³.0⁵,¹⁰]octadeca-7,15-diene
-
135821-74-8
yes
1,2,3-trichloropropane
202-486-1
96-18-4
Carc. 1B; Repr. 1B; Acute Tox. 4
yes
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-bis(2-methoxyethoxy)ethane; TEGDME; triethylene glycol dimethyl ether; triglyme
203-977-3
112-49-2
Repr. 1B
yes
1,2-dichloroethane; ethylene dichloride
203-458-1
107-06-2
Flam. Liq. 2; Carc. 1B; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
1,2-diethoxyethane
211-076-1
629-14-1
Flam. Liq. 2; Repr. 1A; Eye Irrit. 2
yes
1,2-dimethoxyethane; ethylene glycol dimethyl ether; EGDME
203-794-9
110-71-4
Flam. Liq. 2; Repr. 1B; Acute Tox. 4
yes
1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione; TGIC
219-514-3
2451-62-9
Muta. 1B; Acute Tox. 3; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
1,3,5-tris-[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione
TEPIC-H
423-400-0
59653-74-6
Muta. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
1,3-propanesultone; 1,2-oxathiolane 2,2-dioxide
214-317-9
1120-71-4
Carc. 1B; Acute Tox. 4
yes
1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene
236-948-9
13560-89-9
yes
1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (''Dechlorane Plus''™) including any of its individual anti- and syn-isomers or any combination thereof
-
-
yes
1,7,7-Trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one; 3-Benzylidene camphor
239-139-9
15087-24-8
yes
1-bromopropane; n-propyl bromide
203-445-0
106-94-5
Flam. Liq. 2; Repr. 1B; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
1-vinylimidazole
214-012-0
1072-63-5
Repr. 1B
yes
2,2'-dichloro-4,4'-methylenedianiline; 4,4'-methylene bis(2-chloroaniline)
202-918-9
101-14-4
Carc. 1B; Acute Tox. 4
yes
2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propionic acid
236-236-8
13252-13-6
yes
2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionyl fluoride
218-173-8
2062-98-8
yes
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