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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 08 December 2023. Database contains 4753 unique substances/entries.
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Pyr. Liq. 1; Skin Corr. 1B
259-537-6
55219-65-3
Repr. 1B; Lact.; Acute Tox. 4
256-103-8
43121-43-3
Acute Tox. 4; Skin Sens. 1
200-875-0
75-50-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
200-875-0
75-50-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
218-962-7
2303-17-5
Acute Tox. 4; STOT RE 2; Skin Sens. 1
BASIC YELLOW 105; C.I. BASIC YELLOW 105
405-860-4
121315-16-0
Skin Sens. 1
405-060-5
118712-89-3
Skin Irrit. 2
443-150-6
101226-85-1
Flam. Liq. 3
250-517-2
31218-83-4
Acute Tox. 3
205-860-2
156-60-5
Flam. Liq. 2; Acute Tox. 4
238-009-9
14166-21-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
SQ 27,616
416-020-1
96314-26-0
Repr. 2; Skin Sens. 1
SQ28,646
419-160-1
90657-55-9
Repr. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
231-186-3
7443-52-9
Acute Tox. 4
DHP OPT
445-770-2
42031-28-7
Eye Dam. 1
229-977-3
6876-12-6
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
AMINODIOXEPAN
419-050-3
79944-37-9
Skin Sens. 1
FC4010
417-290-3
147086-81-5
Acute Tox. 4
618-075-9
87820-88-0
Carc. 2; Acute Tox. 4
204-854-7
127-65-1
Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1
211-986-9
731-27-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
211-986-9
731-27-1
Acute Tox. 2; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
208-740-8
540-23-8
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
208-741-3
540-25-0
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
265-697-8
65321-67-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
203-625-9
108-88-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
260-515-3
57018-04-9
Skin Sens. 1
TITANYL OXALAAT
403-260-7
31363-92-5
Eye Dam. 1
231-441-9
7550-45-0
Skin Corr. 1B
236-675-5
13463-67-7
Carc. 2
STANNOUS METHANE SULPHONAT; STANNOUS METHANE SULPHONATE; TIN (II) METHANE SULPHONATE; TIN METHANE SULPHONATE; TIN METHANESULFONATE; TIN SALT FS; ZINN(II) METHANESULFONATE; ZINN(II)-METHANSULFONAT
401-640-7
53408-94-9
Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
231-588-9
7646-78-8
Skin Corr. 1B
201-944-8
89-83-8
Acute Tox. 4; Skin Corr. 1B
205-286-2
137-26-8
Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
200-543-5
62-56-6
Carc. 2; Repr. 2; Acute Tox. 4
202-272-8
93-75-4
Acute Tox. 4
245-740-7
23564-05-8
Muta. 2; Acute Tox. 4; Skin Sens. 1
231-748-8
7719-09-7
Acute Tox. 4; Skin Corr. 1A
RT 1766A
404-820-3
164637-97-2
Skin Irrit. 2; Skin Sens. 1
206-049-6
297-97-2
Acute Tox. 1; Acute Tox. 2
211-362-6
640-15-3
Acute Tox. 3; Acute Tox. 4
200-677-4
68-11-1
Acute Tox. 3; Skin Corr. 1B
254-346-4
39196-18-4
Acute Tox. 1; Acute Tox. 2
207-337-4
463-56-9
Acute Tox. 4
207-341-6
463-71-8
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
248-924-5
28249-77-6
Acute Tox. 4
200-541-4
62-55-5
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
246-901-4
25366-23-8
Acute Tox. 4
428-650-4
153719-23-4
Acute Tox. 4

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