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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 17 May 2024. Database contains 4753 unique substances/entries.
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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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572-48-5
Acute Tox. 3
227-424-0
5836-29-3
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
200-285-3
56-72-4
Acute Tox. 2; Acute Tox. 4
204-195-5
117-52-2
Acute Tox. 3; STOT RE 1
201-378-1
81-82-3
STOT RE 2
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B Bacteria and similar species
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68583-16-4
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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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.
204-810-7
126-90-9
Skin Sens. 1B
KUPFER-II-METHANSULFONAT; KUPFERMETHANSULFONAT
405-400-2
54253-62-2
Acute Tox. 4; Eye Dam. 1
235-113-6
12069-69-1
Acute Tox. 4; Eye Irrit. 2
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
231-847-6
7758-98-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
231-159-6
7440-50-8
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
243-815-9
20427-59-2
Acute Tox. 2; Acute Tox. 4; Eye Dam. 1
231-842-9
7758-89-6
Acute Tox. 4
ALLYL SUCROSE
419-640-0
68784-14-5
Acute Tox. 4
Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.
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STOT RE 2
INDULIN MQK-1M
413-770-1
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Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
SUBSTANCE S171393
427-390-9
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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.
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
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F Fungi
215-273-3
1317-42-6
Skin Sens. 1
233-334-2
10124-43-3
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
215-154-6
1307-96-6
Acute Tox. 4; Skin Sens. 1
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77332.
269-051-6
68186-89-0
Carc. 1A; STOT RE 1; Skin Sens. 1
261-346-8
58591-45-0
Carc. 1A; STOT RE 1; Skin Sens. 1
442-750-5
113066-89-0
Carc. 1A; Acute Tox. 2; STOT RE 1; Skin Sens. 1
233-402-1
10141-05-6
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
200-755-8
71-48-7
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
208-169-4
513-79-1
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
231-158-0
7440-48-4
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydrogenated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.
302-682-8
94114-47-3
Carc. 1B
The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.
302-683-3
94114-48-4
Carc. 1B
433-460-1
210880-92-5
Acute Tox. 4
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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
204-385-8
120-32-1
Carc. 2; Repr. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1; Eye Dam. 1; STOT RE 2
216-935-4
1702-17-6
Eye Dam. 1
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P Parasites

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