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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 04 March 2024. Database contains 4753 unique substances/entries.
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B Bacteria and similar species
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B Bacteria and similar species
256-599-6
50471-44-8
Carc. 2; Repr. 1B; Skin Sens. 1
203-545-4
108-05-4
Flam. Liq. 2; Carc. 2; Acute Tox. 4; STOT SE 3
200-831-0
75-01-4
Press. Gas; Flam. Gas 1; Carc. 1A
201-377-6
81-81-2
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
The combination of wastes formed by the coking of bituminous coal tar pitch. It consists predominantly of carbon.
295-549-8
92062-34-5
Carc. 1B
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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.
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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.
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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.
601-810-2
12185-10-3
Pyr. Sol. 1; Acute Tox. 2; Skin Corr. 1A
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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.
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P Parasites
607-955-8
2655-14-3
Acute Tox. 4
215-535-7
1330-20-7
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
215-089-3
1300-71-6
Acute Tox. 3; Skin Corr. 1B
215-091-4
1300-73-8
Acute Tox. 3; STOT RE 2
219-364-9
2425-10-7
Acute Tox. 4
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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.
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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.
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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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B Bacteria and similar species
Z-6
402-280-3
149144-82-1
Eye Irrit. 2; Skin Irrit. 2
205-232-8
136-23-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
238-270-9
14324-55-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
231-592-0
7646-85-7
Acute Tox. 4; Skin Corr. 1B
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Zinc chromate EC / List no: 236-878-9 | CAS no: 13530-65-9
Pentazinc chromate octahydroxide EC / List no: 256-418-0 | CAS no: 49663-84-5
Potassium hydroxyoctaoxodizincatedichromate(1-) EC / List no: 234-329-8 | CAS no: 11103-86-9
Chromic acid, potassium zinc salt EC / List no: 255-252-6 | CAS no: 41189-36-0
Zinc dichromate EC / List no: 237-843-0 | CAS no: 14018-95-2
C.I. Pigment Yellow 36 EC / List no: 609-398-6 | CAS no: 37300-23-5
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Carc. 1A; Acute Tox. 4; Skin Sens. 1
425-240-7
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Eye Dam. 1
231-175-3
7440-66-6
Water-react. 1; Pyr. Sol. 1
231-793-3
7733-02-0
Acute Tox. 4; Eye Dam. 1
616-096-8
7446-19-7
Acute Tox. 4; Eye Dam. 1
417-130-2
1379689-21-0
Eye Dam. 1
235-180-1
12122-67-7
STOT SE 3; Skin Sens. 1
205-288-3
137-30-4
Acute Tox. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1; Skin Sens. 1
936-037-2
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yes
231-176-9
7440-67-7
Water-react. 1; Pyr. Sol. 1
231-176-9
7440-67-7
Self-heat. 1
605-037-1
156052-68-5
Skin Sens. 1
226-009-1
5216-25-1
Carc. 1B; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
202-634-5
98-07-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
202-635-0
98-08-8
Flam. Liq. 2
202-709-2
98-87-3
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
201-254-7
80-15-9
Org. Perox. E; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
229-851-8
6786-83-0
yes
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
202-847-3
100-39-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-853-6
100-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
614-054-3
67375-30-8
Acute Tox. 3; STOT RE 2; STOT SE 3

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