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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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238-034-5
14177-55-0
Carc. 1A; STOT RE 1; Skin Sens. 1
215-204-7
1313-27-5
Carc. 2; Eye Irrit. 2; STOT SE 3
200-820-0
74-89-5
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-820-0
74-89-5
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
203-083-3
103-16-2
Eye Irrit. 2; Skin Sens. 1
230-042-7
6923-22-4
Muta. 2; Acute Tox. 2; Acute Tox. 3
217-129-5
1746-81-2
Acute Tox. 4; STOT RE 2
205-766-1
150-68-5
Carc. 2; Acute Tox. 4
225-062-8
4636-83-3
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-815-1
110-91-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
239-213-0
15159-40-7
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
205-628-0
144-41-2
Acute Tox. 3
248-505-7
27519-02-4
Skin Sens. 1B
201-328-9
81-14-1
Carc. 2
201-329-4
81-15-2
Expl. 1.1; Carc. 2
yes
200-806-4
74-31-7
Skin Sens. 1
202-831-6
100-22-1
Acute Tox. 4
203-744-6
110-18-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
203-336-8
105-83-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
200-679-5
68-12-2
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
yes
210-338-2
613-35-4
Carc. 1B; Muta. 2; Acute Tox. 4
227-062-3
5625-90-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1; Eye Dam. 1
202-959-2
101-61-1
Carc. 1B
yes
205-319-0
138-24-9
Acute Tox. 3
205-149-7
134-62-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
202-088-8
91-66-7
Acute Tox. 3; STOT RE 2
204-495-6
121-72-2
Acute Tox. 3; STOT RE 2
210-199-8
609-72-3
Acute Tox. 3; STOT RE 2
202-805-4
99-97-8
Acute Tox. 3; STOT RE 2
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
204-493-5
121-69-7
Carc. 2; Acute Tox. 3
220-623-3
2836-04-6
Acute Tox. 3
200-316-0
57-14-7
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; Skin Corr. 1B
247-161-5
25646-71-3
Acute Tox. 4; Skin Sens. 1
211-952-3
719-96-0
Skin Irrit. 2
213-103-2
924-42-5
Carc. 1B; Muta. 1B; STOT RE 1
205-223-9
135-88-6
Carc. 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
204-658-1
123-86-4
Flam. Liq. 3; STOT SE 3
205-480-7
141-32-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
202-615-1
97-88-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
209-669-5
590-01-2
Flam. Liq. 3
203-700-6
109-74-0
Flam. Liq. 2; Acute Tox. 3
200-652-8
67-43-6
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
202-411-2
95-33-0
Skin Sens. 1
220-250-6
2687-91-4
Repr. 1B
203-135-5
103-69-5
Acute Tox. 3; STOT RE 2
203-777-6
110-54-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
202-969-7
101-72-4
Acute Tox. 4; Skin Sens. 1
212-828-1
872-50-4
Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
yes
211-795-0
696-44-6
Acute Tox. 3; STOT RE 2

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