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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 21 June 2024. Database contains 4753 unique substances/entries.
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201-557-4
84-74-2
Repr. 1B
yes
200-824-2
74-95-3
Acute Tox. 4
215-125-8
1303-86-2
Repr. 1B
yes
ZK RT 1507
417-760-8
134164-24-2
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
202-327-6
94-36-0
Org. Perox. B; Eye Irrit. 2; Skin Sens. 1
205-886-4
191-30-0
Carc. 1B; Muta. 2
205-878-0
189-64-0
Carc. 1B; Muta. 2
200-181-8
53-70-3
Carc. 1B
206-382-7
334-88-3
Carc. 1B
206-373-8
333-41-5
Acute Tox. 4
215-481-4
1327-53-3
Carc. 1A; Acute Tox. 2; Skin Corr. 1B
yes
215-116-9
1303-28-2
Carc. 1A; Acute Tox. 3
yes
237-499-1
13820-41-2
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 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
-
74195-78-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-793-5
15699-18-0
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
240-973-0
16919-58-7
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
422-670-7
150202-11-2
Repr. 2; Acute Tox. 3; STOT RE 2
GENIPLEX A
401-610-3
122012-52-6
Acute Tox. 4; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
234-454-8
12004-35-2
Carc. 1A; STOT RE 1; Skin Sens. 1
205-016-3
131-17-9
Acute Tox. 4
233-689-3
10311-84-9
Acute Tox. 2; Acute Tox. 3
203-733-6
110-05-4
Org. Perox. E; Flam. Liq. 2; Muta. 2
CM 26-137
406-052-4
125078-60-6
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
210-937-9
626-23-3
Flam. Liq. 3; Acute Tox. 4
205-017-9
131-18-0
Repr. 1B
yes
DNOAI
408-190-0
7585-14-0
Pyr. Liq. 1; Skin Corr. 1B
203-921-8
111-92-2
Flam. Liq. 3; Acute Tox. 4
205-575-3
142-96-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
204-697-4
124-40-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
204-697-4
124-40-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
686-814-2
34363-01-4
Skin Irrit. 2; Skin Sens. 1
218-961-1
2303-16-4
Carc. 2; Acute Tox. 4
DIRECT BLUE 199
416-180-2
12222-04-7
Acute Tox. 4; STOT RE 2
204-424-9
120-78-5
Skin Sens. 1
213-800-1
1014-69-3
Acute Tox. 4
241-109-5
17040-19-6
Acute Tox. 3; Acute Tox. 4
213-052-6
919-86-8
Acute Tox. 3
204-801-8
126-75-0
Acute Tox. 1; Acute Tox. 2
212-758-1
867-27-6
Acute Tox. 3
206-053-8
298-03-3
Acute Tox. 1; Acute Tox. 2
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2
219-971-9
2587-90-8
Acute Tox. 2; Acute Tox. 3
211-666-9
682-80-4
Acute Tox. 2; Acute Tox. 3
258-256-6
52918-63-5
Acute Tox. 3
-
1563-67-3
Acute Tox. 3
206-376-4
334-48-5
Skin Irrit. 2; Eye Irrit. 2
208-764-9
541-02-6
yes
200-024-3
50-29-3
Carc. 2; Acute Tox. 3; STOT RE 1

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