EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the 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).

Last updated 14 lipnja 2024. Database contains 4917 unique substances/entries.
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A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of cycloparaffinic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approximately 73°C to 85°C (163°F to 185°F).
295-529-9
92062-15-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
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 C5 through C10 and boiling in the range of approximately 35°C to 160°C (95°F to 320°F).
265-192-2
64742-89-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. 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).
270-988-8
68512-78-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
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
Details
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
Details
604-636-5
148477-71-8
Carc. 1B; Repr. 2; STOT RE 2; Skin Sens. 1B
Details
606-523-6
203313-25-1
Repr. 2; STOT SE 3; Eye Irrit. 2; Skin Sens. 1A
Details
601-505-4
118134-30-8
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
Details
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F Fungi
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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.
Details
293-901-5
91648-39-4
Repr. 1B; STOT RE 1
Details
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B Bacteria and similar species
Details
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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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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P Parasites
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P Parasites
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427-930-3
250639-69-1
Skin Sens. 1
Details
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
C Carcinogenic (article 57a)
Details
234-239-9
11005-63-3
Acute Tox. 3; STOT RE 2
Details
269-710-8
68310-42-9
Acute Tox. 2
Details
269-439-5
68239-26-9
Acute Tox. 2
Details
200-319-7
57-24-9
Acute Tox. 1; Acute Tox. 2
Details
202-851-5
100-42-5
Flam. Liq. 3; Repr. 2; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
Details
202-476-7
96-09-3
Carc. 1B; Acute Tox. 4; Eye Irrit. 2
Details
STYRENE SULPHONYL CHLORIDE
404-770-2
2633-67-2
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
232-752-2
9014-01-1
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
Details
203-570-0
108-30-5
Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
Details
619-394-6
99105-77-8
Repr. 2; STOT RE 2; Skin Sens. 1A
Details
202-388-9
95-06-7
Carc. 1B; Acute Tox. 4
Details
222-995-2
3689-24-5
Acute Tox. 1; Acute Tox. 2
Details
807-366-8
946578-00-3
Acute Tox. 4
Details
231-722-6
7704-34-9
Skin Irrit. 2
Details
616-572-5
7790-84-3
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
HH2 Specific target organ toxicity after repeated exposure (Article 57(f) - human health)
Details
263-467-1
62229-08-7
R Toxic for reproduction (article 57c)
Details
226-218-8
5329-14-6
Eye Irrit. 2; Skin Irrit. 2
Details
204-482-5
121-57-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
234-129-0
10545-99-0
Skin Corr. 1B; STOT SE 3
Details
231-195-2
7446-09-5
Press. Gas; Acute Tox. 3; STOT SE 1; Skin Corr. 1B
Details
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13451-08-6
Skin Corr. 1B
Details
231-639-5
7664-93-9
Skin Corr. 1A
Details
626-360-4
15244-35-6
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
HH2 Specific target organ toxicity after repeated exposure (Article 57(f) - human health)
Details
232-245-6
7791-25-5
Skin Corr. 1B; STOT SE 3
Details
220-281-5
2699-79-8
Press. Gas; Acute Tox. 3; STOT RE 2
Details
201-782-8
87-90-1
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
Details
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P Parasites
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P Parasites
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