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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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.

Last updated 26 april 2024. Database contains 4753 unique substances/entries.
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231-901-9
7778-39-4
Carc. 1A; Acute Tox. 3
yes
231-890-0
7775-14-6
Self-heat. 1; Acute Tox. 4
231-889-5
7775-11-3
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
231-887-4
7775-09-9
Ox. Sol. 1; Acute Tox. 4
EPIKURE DX 6906
417-350-9
776326-15-9
Skin Irrit. 2; Eye Dam. 1
231-853-9
7761-88-8
Ox. Sol. 2; Skin Corr. 1B
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
231-847-6
7758-98-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
231-846-0
7758-97-6
Carc. 1B; Repr. 1A; STOT RE 2
yes
231-842-9
7758-89-6
Acute Tox. 4
231-832-4
7758-09-0
Ox. Sol. 2; Acute Tox. 3
231-829-8
7758-01-2
Ox. Sol. 1; Carc. 1B; Acute Tox. 3
231-827-7
7757-95-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
616-473-7
77536-68-6
Carc. 1A; STOT RE 1
616-472-1
77536-67-5
Carc. 1A; STOT RE 1
616-471-6
77536-66-4
Carc. 1A; STOT RE 1
MAGME(R) 200 MONOMER
403-230-3
77402-05-2
Carc. 1B; Muta. 1B; Skin Corr. 1B; Skin Sens. 1
MAGME 100 MONOMEER
401-890-7
77402-03-0
Carc. 1B; Muta. 1B; Acute Tox. 4; Eye Irrit. 2
231-801-5
7738-94-5
yes
EPSI
410-220-2
77375-79-2
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
426-890-4
77341-67-4
Eye Dam. 1
231-793-3
7733-02-0
Acute Tox. 4; Eye Dam. 1
ICI204636 HYDROGEN FUMARATE
415-180-1
773058-82-5
Acute Tox. 4; Eye Dam. 1
231-786-5
7727-54-0
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
231-781-8
7727-21-1
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
231-778-1
7726-95-6
Acute Tox. 2; Skin Corr. 1A
231-768-7
7723-14-0
Flam. Sol. 1
3-CHLORO-4,5-DIFLUOROBENZOTRIFLUORIDE
401-930-3
77227-99-7
Flam. Liq. 3; Acute Tox. 4
231-765-0
7722-84-1
Ox. Liq. 1; Acute Tox. 4; Skin Corr. 1A
231-760-3
7722-64-7
Ox. Sol. 2; Repr. 2; Acute Tox. 4
JOF 2822 5F; JOF 2822 5FL; JOF 4443
420-960-8
77214-82-5
Eye Dam. 1
231-753-5
7720-78-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
231-749-3
7719-12-2
Acute Tox. 2; STOT RE 2; Skin Corr. 1A
231-748-8
7719-09-7
Acute Tox. 4; Skin Corr. 1A
278-636-5
77182-82-2
Repr. 1B; Acute Tox. 4; STOT RE 2
231-743-0
7718-54-9
Carc. 1A; Muta. 2; Repr. 1B; Acute Tox. 3; STOT RE 1; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
SETALUX EPC 4690
420-190-2
771478-66-1
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
212-230-0
771-29-9
Org. Perox. D; Acute Tox. 4; Skin Corr. 1B
SILAN MCS
410-270-5
770722-46-8
Skin Corr. 1A
SILAN DCS
407-180-3
770722-36-6
Skin Corr. 1A
231-722-6
7704-34-9
Skin Irrit. 2
231-720-5
7700-17-6
Acute Tox. 3
201-058-1
77-78-1
Carc. 1B; Muta. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
201-052-9
77-73-6
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-039-8
77-58-7
Muta. 2; Repr. 1B; STOT RE 1
201-029-3
77-47-4
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
201-004-7
77-09-8
Carc. 1B; Muta. 2; Repr. 2
yes
231-714-2
7697-37-2
Ox. Liq. 3; Acute Tox. 3; Skin Corr. 1A
231-711-6
7696-12-0
Carc. 2; Acute Tox. 4; STOT SE 2
BMS 187266-02; S-TIPAC
430-300-0
76932-17-7
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1

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