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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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A complex combination of hydrocarbons obtained from the stabilization of catalytic cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
270-803-0
68478-22-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by the fractionation of catalytic cracked naphtha and distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
273-170-9
68952-77-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
The complex combination of hydrocarbons from the distillation of the products from catalytic cracked distillates and catalytic cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C1 through C4.
269-617-2
68307-98-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from fractionation of catalytic cracked clarified oil and thermal cracked vacuum residue. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
270-802-5
68478-21-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
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P Parasites
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P Parasites
201-782-8
87-90-1
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
220-281-5
2699-79-8
Press. Gas; Acute Tox. 3; STOT RE 2
232-245-6
7791-25-5
Skin Corr. 1B; STOT SE 3
626-360-4
15244-35-6
yes
231-639-5
7664-93-9
Skin Corr. 1A
-
13451-08-6
Skin Corr. 1B
231-195-2
7446-09-5
Press. Gas; Acute Tox. 3; Skin Corr. 1B
234-129-0
10545-99-0
Skin Corr. 1B; STOT SE 3
204-482-5
121-57-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
226-218-8
5329-14-6
Eye Irrit. 2; Skin Irrit. 2
263-467-1
62229-08-7
yes
616-572-5
7790-84-3
yes
231-722-6
7704-34-9
Skin Irrit. 2
807-366-8
946578-00-3
Acute Tox. 4
222-995-2
3689-24-5
Acute Tox. 1; Acute Tox. 2
202-388-9
95-06-7
Carc. 1B; Acute Tox. 4
619-394-6
99105-77-8
Repr. 2; STOT RE 2; Skin Sens. 1A
203-570-0
108-30-5
Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
232-752-2
9014-01-1
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
STYRENE SULPHONYL CHLORIDE
404-770-2
2633-67-2
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
202-476-7
96-09-3
Carc. 1B; Acute Tox. 4; Eye Irrit. 2
202-851-5
100-42-5
Flam. Liq. 3; Repr. 2; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
200-319-7
57-24-9
Acute Tox. 1; Acute Tox. 2
269-439-5
68239-26-9
Acute Tox. 2
269-710-8
68310-42-9
Acute Tox. 2
234-239-9
11005-63-3
Acute Tox. 3; STOT RE 2
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
yes
427-930-3
250639-69-1
Skin Sens. 1
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P Parasites
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P Parasites
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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
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B Bacteria and similar species
A colorless, refined petroleum distillate that is free from rancid or objectionable odors and that boils in a range of approximately 148.8°C to 204.4°C (300°F to 400°F).
232-489-3
8052-41-3
Carc. 1B; Muta. 1B; STOT RE 1; Asp. Tox. 1
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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.
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F Fungi
601-505-4
118134-30-8
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
606-523-6
203313-25-1
Repr. 2; STOT SE 3; Eye Irrit. 2; Skin Sens. 1A
604-636-5
148477-71-8
Carc. 1B; Repr. 2; STOT RE 2; Skin Sens. 1B
A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C9 through C12 and boiling in the range of approximately 140°C to 220°C (284°F to 428°F).
265-191-7
64742-88-7
STOT RE 1; Asp. Tox. 1
A complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135°C to 210°C (275°F to 410°F).
265-199-0
64742-95-6
Carc. 1B; Muta. 1B; Asp. Tox. 1

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