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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 25 April 2024. Database contains 4753 unique substances/entries.
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425-240-7
-
Eye Dam. 1
417-130-2
1379689-21-0
Eye Dam. 1
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
PC-709
413-420-8
144736-29-8
Skin Corr. 1B; Skin Sens. 1
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
500-036-1
25214-70-4
yes
1 - 2.5 moles ethoxylated
500-209-1
68412-54-4
yes
500-024-6
9016-45-9
yes
500-033-5
25068-38-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
616-221-6
7541-49-3
Skin Irrit. 2
602-929-2
123333-53-9
Expl. 1.3
620-419-8
606-35-9
Expl. 1.1; Acute Tox. 4
618-344-0
9002-93-1
yes
687-832-3
1119449-37-4
yes
695-989-4
2527-66-4
Acute Tox. 4; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
687-833-9
1119449-38-5
yes
604-395-6
14409-72-4
yes
606-640-2
2079-00-7
Acute Tox. 2
620-358-7
140-41-0
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
620-041-3
907204-31-3
Lact.
621-341-7
2315-61-9
yes
635-388-6
521947-27-3
yes
635-389-1
186825-36-5
yes
635-391-2
142731-63-3
yes
635-696-0
186825-39-8
yes
621-345-9
2315-67-5
yes
619-823-7
494793-67-8
Carc. 2
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
615-339-5
71751-41-2
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
611-595-7
57960-19-7
Skin Sens. 1; STOT SE 1; STOT RE 2
603-921-1
135410-20-7
Acute Tox. 4
603-801-9
134237-50-6
yes
604-314-4
142844-00-6
yes
672-776-4
348635-87-0
Carc. 2; Eye Irrit. 2
616-473-7
77536-68-6
Carc. 1A; STOT RE 1
616-471-6
77536-66-4
Carc. 1A; STOT RE 1
616-472-1
77536-67-5
Carc. 1A; STOT RE 1
601-650-3
12001-29-5
Carc. 1A; STOT RE 1
601-649-8
12001-28-4
Carc. 1A; STOT RE 1
601-801-3
12172-73-5
Carc. 1A; STOT RE 1
620-425-0
68049-83-2
Repr. 1B; STOT RE 2
603-524-3
131860-33-8
Acute Tox. 3
620-403-0
8003-05-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
617-356-3
82560-54-1
Repr. 2; Acute Tox. 3; Acute Tox. 4
605-769-1
17606-31-4
Acute Tox. 4
691-719-4
1072957-71-1
Acute Tox. 3
603-802-4
134237-51-7
yes
617-373-6
82657-04-3
Carc. 2; Acute Tox. 3; Acute Tox. 2; STOT RE 1; Skin Sens. 1B
608-595-4
312600-89-8
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1

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