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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 February 2024. Database contains 4753 unique substances/entries.
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Acute Tox. 4; Skin Sens. 1
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Acute Tox. 4; Skin Sens. 1
253-704-7
37894-46-5
Repr. 1B; Acute Tox. 4; STOT RE 2
200-814-8
74-84-0
Flam. Gas 1; Press. Gas
203-473-3
107-21-1
Acute Tox. 4
200-837-3
75-08-1
Flam. Liq. 2; Acute Tox. 4
308-208-6
97925-95-6
Repr. 1B
200-578-6
64-17-5
Flam. Liq. 2
240-718-3
16672-87-0
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1C
250-010-6
30043-49-3
Skin Sens. 1
214-984-6
1239-45-8
Muta. 2; Acute Tox. 2; Acute Tox. 4
249-981-9
29973-13-5
Acute Tox. 4
209-242-3
563-12-2
Acute Tox. 3; Acute Tox. 4
245-949-3
23947-60-6
Acute Tox. 4
204-121-1
116-01-8
Acute Tox. 4
236-152-1
13194-48-4
Acute Tox. 2; Acute Tox. 1; Acute Tox. 3; Skin Sens. 1
202-075-7
91-53-2
Acute Tox. 4
429-020-1
204254-96-6
STOT RE 2; Skin Sens. 1
429-680-0
122665-86-5
Skin Sens. 1
430-220-6
141942-85-0
Eye Irrit. 2
211-694-1
687-47-8
Flam. Liq. 3; STOT SE 3; Eye Dam. 1
HOE 70542
401-290-5
103112-35-2
Carc. 1B
DM-8
405-880-3
100501-62-0
Skin Sens. 1
GABAPENTINE ETHYL ESTER; PD 137016
415-970-4
133481-10-4
Acute Tox. 4; STOT RE 2
414-920-9
60658-04-0
Acute Tox. 3; STOT RE 1; Skin Sens. 1
3-NITROBENZYLIDENETHYLESTER
404-490-0
39562-16-8
Eye Dam. 1; Skin Sens. 1
429-220-9
132584-17-9
Skin Sens. 1
EPSI
410-220-2
77375-79-2
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
266-362-9
66441-23-4
Skin Sens. 1
SB-201999
415-680-8
143468-96-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
230-391-5
7085-85-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
ECPA
427-630-2
99469-99-5
Eye Dam. 1
LUPEROX 533
403-320-2
67567-23-1
Org. Perox. D; Flam. Liq. 3
CA 875 B
414-450-4
88805-65-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
427-110-5
948991-29-5
Acute Tox. 4; STOT RE 2
443-870-0
163520-33-0
Acute Tox. 4; Skin Sens. 1
6,8-DICHLORETHYLCAPRYLAT; ETHYL-6,8 DICHLORO OCTANOATE
435-080-1
1070-64-0
Skin Sens. 1
422-360-1
100491-29-0
Skin Sens. 1
205-500-4
141-78-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
205-438-8
140-88-5
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
203-290-9
105-36-2
Acute Tox. 2; Acute Tox. 1
203-294-0
105-39-5
Acute Tox. 3
208-778-5
541-41-3
Flam. Liq. 2; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
428-030-3
67914-69-6
Acute Tox. 4; STOT RE 2
203-721-0
109-94-4
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
275-897-7
71720-48-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
202-598-0
97-64-3
Flam. Liq. 3; STOT SE 3; Eye Dam. 1
202-597-5
97-63-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
611-089-6
540-67-0
Flam. Gas 1; Press. Gas
244-845-5
22212-55-1
Acute Tox. 4

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