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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 18 April 2024. Database contains 4753 unique substances/entries.
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203-377-1
106-24-1
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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P Parasites
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Carc. 2
232-589-7
9001-22-3
Resp. Sens. 1
278-636-5
77182-82-2
Repr. 1B; Acute Tox. 4; STOT RE 2
EW 400; GLUCOPROTAMIN
403-950-8
164907-72-6
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
203-856-5
111-30-8
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1A
200-240-8
55-63-0
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-240-8
55-63-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
203-474-9
107-22-2
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
206-058-5
298-12-4
Eye Dam. 1; Skin Sens. 1B
213-997-4
1071-83-6
Eye Dam. 1
617-243-9
81591-81-3
Acute Tox. 4
219-468-4
2439-99-8
Eye Dam. 1
201-964-7
90-05-1
Acute Tox. 4; Eye Irrit. 2; 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.
GUANIDINIUMBENZOAT
429-820-0
26739-54-8
Acute Tox. 4
200-002-3
50-01-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
620-427-1
108173-90-6
Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 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
TILCOM HTB
411-740-2
22411-22-9
Eye Dam. 1; Skin Sens. 1
600-130-3
100784-20-1
Repr. 1B
HALOXYFOP ETHOXYETHYL EST
402-560-5
87237-48-7
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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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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12035-71-1
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
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B Bacteria and similar species
218-165-4
2058-94-8
yes
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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.
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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.
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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.
200-962-3
76-44-8
Carc. 2; Acute Tox. 3; STOT RE 2
213-831-0
1024-57-3
Carc. 2; Acute Tox. 3; STOT RE 2
206-803-4
376-06-7
yes
203-767-1
110-43-0
Flam. Liq. 3; Acute Tox. 4
203-388-1
106-35-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2
204-608-9
123-19-3
Flam. Liq. 3; Acute Tox. 4
205-563-8
142-82-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
203-838-7
111-14-8
Skin Corr. 1B
245-737-0
23560-59-0
Acute Tox. 3
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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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