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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 24 April 2024. Database contains 4753 unique substances/entries.
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229-335-2
6477-64-1
yes
232-064-2
7784-40-9
Carc. 1A; Repr. 1A; Acute Tox. 3; STOT RE 2
yes
215-267-0
1317-36-8
yes
234-853-7
12036-76-9
yes
231-100-4
7439-92-1
Repr. 1A; Lact.
yes
239-290-0
15245-44-0
yes
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.
215-693-7
1344-37-2
Carc. 1B; Repr. 1A; STOT RE 2
yes
235-038-9
12060-00-3
yes
235-727-4
12626-81-2
yes
BLEIMETHANSULFONAT; LEAD (II) METHANESULFONATE; LEAD METHANE SULPHONATE; LEAD SALT FP
401-750-5
17570-76-2
Repr. 1A; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
yes
210-894-6
625-45-6
Repr. 1B; Acute Tox. 4; Skin Corr. 1B
yes
201-329-4
81-15-2
Expl. 1.1; Carc. 2
yes
200-679-5
68-12-2
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
yes
202-959-2
101-61-1
Carc. 1B
yes
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
212-828-1
872-50-4
Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
yes
201-182-6
79-16-3
Repr. 1B
yes
202-716-0
98-95-3
Carc. 2; Repr. 1B; Acute Tox. 3; STOT RE 1
yes
206-400-3
335-76-2
Carc. 2; Repr. 1B; Lact.
yes
246-672-0
25154-52-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
1 - 2.5 moles ethoxylated
500-209-1
68412-54-4
yes
500-024-6
9016-45-9
yes
931-755-2
-
yes
931-756-8
-
yes
931-753-1
-
yes
931-754-7
-
yes
939-993-9
-
yes
-
-
yes
938-618-6
-
yes
932-998-7
-
yes
202-429-0
95-53-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2
yes
209-136-7
556-67-2
Repr. 2
yes
-
-
yes
215-235-6
1314-41-6
yes
250-339-5
30784-30-6
yes
201-280-9
80-46-6
yes
241-427-4
17404-66-9
yes
247-770-6
26543-97-5
yes
203-199-4
104-40-5
yes
276-745-2
72629-94-8
yes
235-067-7
12065-90-6
yes
256-418-0
49663-84-5
yes
603-902-8
13517-20-9
yes
600-611-8
10486-00-7
yes
600-419-4
10332-33-9
yes
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
206-793-1
375-73-5
yes
206-587-1
355-46-4
yes

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