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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293-766-2
91082-52-9
Carc. 1B; Muta. 1B
Details
Pyridine bases boiling in the range of approximately 125°C to 160°C (257°F 320°F) obtained by distillation of neutralized acid extract of the base-containing tar fraction obtained by the distillation of bituminous coal tars. Composed chiefly of lutidines and picolines.
295-548-2
92062-33-4
Carc. 1B; Muta. 1B
Details
274-560-1
70321-67-4
Carc. 1B; Muta. 1B
Details
293-767-8
91082-53-0
Carc. 1B; Muta. 1B
Details
271-020-7
68513-87-1
Carc. 1B; Muta. 1B
Details
An oil distilled from brown-coal tar. Composed primarily of aliphatic, naphthenic and one- to three-ring aromatic hydrocarbons, their alkyl derivatives, heteroaromatics and one- and two-ring phenols boiling in the range of approximately 150°C to 360°C (302°F to 680°F).
309-885-0
101316-83-0
Carc. 1A
Details
The distillate from lignite tar boiling in the range of approximately 80°C to 250°C (176°F to 482°F). Composed primarily of aliphatic and aromatic hydrocarbons and monobasic phenols.
302-674-4
94114-40-6
Carc. 1B; Muta. 1B
Details
A distillate from low-temperature coal tar. Composed primarily of hydrocarbons, phenolic compounds and aromatic nitrogen bases boiling in the range of approximately 160°C to 340°C (320°F to 644°F).
309-889-2
101316-87-4
Carc. 1B; Muta. 1B
Details
The distillate from high temperature coal tar having an approximate distillation range of 130°C to 250°C (266°F to 410°F). Composed primarily of naphthalene, alkylnaphthalenes, phenolic compounds, and aromatic nitrogen bases.
266-016-7
65996-82-9
Carc. 1B; Muta. 1B
Details
A tar obtained from low temperature carbonization and low temperature gasification of brown coal. Composed primarily of aliphatic, naphthenic and cyclic aromatic hydrocarbons, heteroaromatic hydrocarbons and cyclic phenols.
309-886-6
101316-84-1
Carc. 1A
Details
Coke- and ash-containing solid residues that separate on distillation and thermal treatment of bituminous coal high temperature tar in distillation installations and storage vessels. Consists predominantly of carbon and contains a small quantity of hetero compounds as well as ash components.
295-535-1
92062-20-9
Carc. 1B
Details
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons with a high solid content of coal- and coke-type materials.
273-615-7
68990-61-4
Carc. 1B
Details
Solids formed during the coking of bituminous coal to produce crude bituminous coal high temperature tar. Composed primarily of coke and coal particles, highly aromatized compounds and mineral substances.
309-726-5
100684-51-3
Carc. 1B
Details
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons. May contain minor amounts of phenolic compounds and aromatic nitrogen bases.
266-024-0
65996-89-6
Carc. 1A
Details
Residues from fractional distillation of low temperature coal tar to remove oils that boil in a range up to approximately 300°C (572°F). Composed primarily of aromatic compounds.
309-887-1
101316-85-2
Carc. 1B
Details
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in low temperature (less than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of condensed ring aromatic hydrocarbons, phenolic compounds, aromatic nitrogen bases, and their alkyl derivatives.
266-025-6
65996-90-9
Carc. 1A
Details
The deposit removed from crude coal tar storages. Composed primarily of coal tar and carbonaceous particulate matter.
293-764-1
91082-50-7
Carc. 1B
Details
The by-product from the destructive distillation of coal. Almost black semisolid. A complex combination of aromatic hydrocarbons, phenolic compounds, nitrogen bases and thiophene.
232-361-7
8007-45-2
Carc. 1A
Details
600-363-0
102851-06-9
Acute Tox. 4; Skin Irrit. 2
Details
200-927-2
76-03-9
Skin Corr. 1A
Details
211-479-2
650-51-1
STOT SE 3
Details
TEBUCONAZOLE RESP. HWG 1608
403-640-2
107534-96-3
Repr. 2; Acute Tox. 4
Details
601-585-0
119168-77-3
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1B
Details
251-793-7
34014-18-1
Acute Tox. 4
Details
204-178-2
117-18-0
Acute Tox. 4; Skin Sens. 1
Details
616-699-6
79538-32-2
Acute Tox. 1; Acute Tox. 2
Details
236-813-4
13494-80-9
Repr. 1B; Lact.
Details
231-193-1
7446-07-3
Repr. 1B; Lact.
Details
608-879-8
335104-84-2
Repr. 2; STOT RE 2; Skin Sens. 1
Details
203-495-3
107-49-3
Acute Tox. 1; Acute Tox. 2
Details
604-715-4
149979-41-9
Carc. 2; Repr. 2
Details
235-963-8
13071-79-9
Acute Tox. 1; Acute Tox. 2
Details
251-637-8
33693-04-8
Acute Tox. 4
Details
227-637-9
5915-41-3
Acute Tox. 4; STOT RE 2
Details
262-967-7
61788-32-7
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
262-967-7
61788-32-7
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
429-170-8
134575-17-0
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
Details
3-BMC
407-620-4
33610-13-8
Resp. Sens. 1; Skin Sens. 1
Details
1,1-DIMETHYLETHOXY-CARBONYL-METHYLEN-TRIPHENYLPHOSPHORAN; DMY; PHOSPHORANE
412-880-7
35000-38-5
Acute Tox. 3; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
Details
208-760-7
540-88-5
Flam. Liq. 2
Details
216-768-7
1663-39-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
212-105-0
762-75-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
Details
200-915-7
75-91-2
Muta. 2
Details
216-653-1
1634-04-4
Flam. Liq. 2; Skin Irrit. 2
Details
208-757-0
540-80-7
Flam. Liq. 2; Acute Tox. 4
Details
606-566-0
20487-40-5
Flam. Liq. 2
Details
222-389-8
3457-61-2
Org. Perox. E; Skin Irrit. 2
Details
TERTIARYBUTYLARSINE; TERTIÄRBUTYLARSIN
423-320-6
4262-43-5
Pyr. Liq. 1; Acute Tox. 2
Details
MJR-580
418-520-5
183130-96-3
Eye Irrit. 2
Details
C.I. DIRECT BLUE 301; DIRECT BLUE 301
408-210-8
124605-82-9
Skin Sens. 1
Details

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