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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 16 April 2024. Database contains 4753 unique substances/entries.
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232-223-6
7790-80-9
Acute Tox. 3; Carc. 2; STOT RE 2
-
-
yes
233-710-6
10325-94-7
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
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Monteponite (CdO) EC / List no: - | CAS no: 12139-21-8
215-146-2
1306-19-0
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
yes
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Sulfuric acid, cadmium salt, hydrate (3:3:8) EC / List no: 616-572-5 | CAS no: 7790-84-3
Sulfuric acid, cadmium salt (1:1), hydrate EC / List no: 626-360-4 | CAS no: 15244-35-6
233-331-6
10124-36-4;31119-53-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
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Sulfuric acid, cadmium salt (1:1), hydrate EC / List no: 626-360-4 | CAS no: 15244-35-6
Sulfuric acid, cadmium salt, hydrate (3:3:8) EC / List no: 616-572-5 | CAS no: 7790-84-3
233-331-6
10124-36-4;31119-53-6
yes
215-147-8
1306-23-6
Carc. 1B; Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4
yes
231-152-8
7440-43-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
231-152-8
7440-43-9
yes
231-152-8
7440-43-9
Pyr. Sol. 1; Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
241-084-0
17010-21-8
Acute Tox. 3; Carc. 2; STOT RE 2
200-362-1
58-08-2
Acute Tox. 4
231-179-5
7440-70-2
Water-react. 2
Z-28
421-670-4
1379765-16-8
Skin Irrit. 2
PIGMENTGELB 82 897
400-710-4
94612-72-3
Acute Tox. 4
231-904-5
7778-44-1
yes
200-848-3
75-20-7
Water-react. 1
233-140-8
10043-52-4
Eye Irrit. 2
237-366-8
13765-19-0
Carc. 1B; Acute Tox. 4
205-861-8
156-62-7
Acute Tox. 4; STOT SE 3; Eye Dam. 1
209-740-0
592-01-8
Acute Tox. 2
232-189-2
7789-78-8
Water-react. 1
231-908-7
7778-54-3
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1B
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-
Expl.
Z 7
402-040-8
148262-93-5
Skin Corr. 1B
215-142-0
1305-99-3
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1; Eye Dam. 1
215-709-2
1344-81-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
243-873-5
20548-54-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
232-283-3
8001-35-2
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
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-
B Bacteria and similar species
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B Bacteria and similar species
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-
B Bacteria and similar species
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-
F Fungi
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-
F Fungi
-
-
P Parasites
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-
P Parasites
219-363-3
2425-06-1
Carc. 1B; Skin Sens. 1
205-087-0
133-06-2
Carc. 2; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
229-879-0
6804-07-5
Flam. Sol. 1; Carc. 1B; Acute Tox. 4
200-555-0
63-25-2
Carc. 2; Acute Tox. 4
234-232-0
10605-21-7
Muta. 1B; Repr. 1B
240-286-6
16118-49-3
Carc. 2; Repr. 1B; Acute Tox. 4
216-353-0
1563-66-2
Acute Tox. 2
200-843-6
75-15-0
Flam. Liq. 2; Repr. 2; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
211-128-3
630-08-0
Flam. Gas 1; Press. Gas; Repr. 1A; Acute Tox. 3; STOT RE 1
200-262-8
56-23-5
Carc. 2; Acute Tox. 3; STOT RE 1
240-408-8
16337-84-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
212-324-1
786-19-6
Acute Tox. 3
259-565-9
55285-14-8
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1

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