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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 12 June 2024. Database contains 4753 unique substances/entries.
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236-675-5
13463-67-7
Carc. 2
231-441-9
7550-45-0
Skin Corr. 1B
TITANYL OXALAAT
403-260-7
31363-92-5
Eye Dam. 1
260-515-3
57018-04-9
Skin Sens. 1
203-625-9
108-88-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
265-697-8
65321-67-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
208-741-3
540-25-0
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
208-740-8
540-23-8
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
211-986-9
731-27-1
Acute Tox. 2; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
211-986-9
731-27-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
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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.
204-854-7
127-65-1
Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1
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P Parasites
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P Parasites
618-075-9
87820-88-0
Carc. 2; Acute Tox. 4
FC4010
417-290-3
147086-81-5
Acute Tox. 4
AMINODIOXEPAN
419-050-3
79944-37-9
Skin Sens. 1
229-977-3
6876-12-6
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
DHP OPT
445-770-2
42031-28-7
Eye Dam. 1
231-186-3
7443-52-9
Acute Tox. 4
SQ28,646
419-160-1
90657-55-9
Repr. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
SQ 27,616
416-020-1
96314-26-0
Repr. 2; Skin Sens. 1
205-860-2
156-60-5
Flam. Liq. 2; Acute Tox. 4
250-517-2
31218-83-4
Acute Tox. 3
443-150-6
101226-85-1
Flam. Liq. 3
405-060-5
118712-89-3
Skin Irrit. 2
BASIC YELLOW 105; C.I. BASIC YELLOW 105
405-860-4
121315-16-0
Skin Sens. 1
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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
218-962-7
2303-17-5
Acute Tox. 4; STOT RE 2; Skin Sens. 1
200-875-0
75-50-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
200-875-0
75-50-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
256-103-8
43121-43-3
Acute Tox. 4; Skin Sens. 1
259-537-6
55219-65-3
Repr. 1B; Lact.; Acute Tox. 4
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Pyr. Liq. 1; Skin Corr. 1B
620-368-1
1031-47-6
Acute Tox. 1; Acute Tox. 2
432-270-4
221354-37-6
Repr. 2; STOT RE 2
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26766-27-8
Acute Tox. 4
245-986-5
24017-47-8
Acute Tox. 3; Acute Tox. 4
401-190-1
101200-48-0
STOT RE 2; Skin Sens. 1
204-800-2
126-73-8
Carc. 2; Acute Tox. 4; Skin Irrit. 2
D 27-046
413-520-1
125792-14-5
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
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Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
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P Parasites
200-149-3
52-68-6
Acute Tox. 4; Skin Sens. 1
200-902-6
75-79-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2

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