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 19 travnja 2024. Database contains 4917 unique substances/entries.
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233-663-1
10294-56-1
Acute Tox. 4; Skin Corr. 1A
Details
233-060-3
10026-13-8
Acute Tox. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
Details
215-236-1
1314-56-3
Skin Corr. 1A
Details
232-178-2
7789-60-8
Skin Corr. 1B; STOT SE 3
Details
231-749-3
7719-12-2
Acute Tox. 2; STOT RE 2; Skin Corr. 1A
Details
233-046-7
10025-87-3
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Skin Corr. 1A
Details
238-887-3
14816-18-3
Repr. 2; Acute Tox. 4; Skin Sens. 1
Details
201-607-5
85-44-9
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
Details
200-332-8
57-47-6
Acute Tox. 2
Details
604-030-0
137641-05-5
STOT RE 2
Details
202-128-4
92-13-7
Acute Tox. 2
Details
201-462-8
83-26-1
Acute Tox. 3; STOT RE 1
Details
635-361-9
243973-20-8
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1A
Details
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
Details
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
Details
205-551-2
142-64-3
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
228-042-7
6094-40-2
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
217-775-8
1951-97-9
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
203-813-0
110-89-4
Flam. Liq. 2; Acute Tox. 3; Skin Corr. 1B
Details
200-076-7
51-03-6
STOT SE 3; Eye Irrit. 2
Details
607-329-4
24151-93-7
Acute Tox. 4
Details
245-430-1
23103-98-2
Carc. 2; Acute Tox. 3; Skin Sens. 1
Details
245-704-0
23505-41-1
Acute Tox. 3; Acute Tox. 4
Details
249-528-5
29232-93-7
Acute Tox. 4; STOT RE 1
Details
The heat treated residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 80°C to 180°C (176°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
310-162-7
121575-60-8
Carc. 1B
Details
The residue obtained during the distillation of high boiling fractions from bituminous coal high temperature tar and/or pitch coke oil, with a softening point of 140° to 170°C (284°F to 392°F) according to DIN 52025. Composed primarily of tri- and polynuclear aromatic compounds which also contain heteroatoms.
302-650-3
94114-13-3
Carc. 1B
Details
The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30°C to 180°C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
266-028-2
65996-93-2
Carc. 1A; Muta. 1B; Repr. 1B
C Carcinogenic (article 57a)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
A complex black solid obtained by the heat treatment of low temperature coal tar pitch. It has a softening point within the approximate range of 50°C to 140°C (122°F to 284°F). Composed primarily of a complex mixture of aromatic compounds.
292-653-5
90669-58-2
Carc. 1B
Details
The product obtained by air-blowing, at elevated temperature, low-temperature coal tar pitch. It has a softening-point within the approximate range of 70°C to 180°C (158°F to 356°F). Composed primarily of a complex mixture of hydrocarbons.
292-654-0
90669-59-3
Carc. 1B
Details
A complex black solid or semi-solid obtained from the distillation of a low temperature coal tar. It has a softening point within the approximate range of 40°C to 180°C (104°F to 356°F). Composed primarily of a complex mixture of hydrocarbons.
292-651-4
90669-57-1
Carc. 1B
Details
The residue from the distillation of a mixture of coal tar and aromatic petroleum streams. A solid with a softening point from 40°C to 180°C (104°F to 356°F). Composed primarily of a complex combination of three or more membered condensed ring aromatic hydrocarbons.
269-109-0
68187-57-5
Carc. 1B
Details
263-072-4
61789-60-4
Carc. 1B
Details
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P Parasites
Details
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-
P Parasites
Details
432-400-1
10102-09-7
Skin Corr. 1A
Details
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B Bacteria and similar species
Details
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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
AOC 2050X
403-430-0
138360-92-6
Eye Dam. 1
Details
BIOPOL HX
403-300-3
127536-43-0
Skin Sens. 1
Details
RX-33
419-590-1
-
Flam. Sol. 1; Skin Sens. 1
Details
427-480-8
176429-22-4
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
427-280-0
176429-27-9
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
215-648-1
1336-36-3
STOT RE 2
Details
618-541-1
9036-19-5
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
608-723-9
32289-58-0
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
Details
608-042-7
27083-27-8
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
Details
PAA HCL; PAA HCL 10L; PAA HCL 10S; PAA HCL 3L; PAA HCL 3S; PAA HCL H; PAA HCL L
415-050-2
71550-12-4
Acute Tox. 4; Skin Sens. 1
Details
X4060
404-035-6
1379801-27-0
Skin Sens. 1
Details
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B Bacteria and similar species
Details
-
299-45-6
Acute Tox. 2; Acute Tox. 1
Details

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