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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640 AMMONIUM SALT; KSMIA; S-102; SMIA
405-990-1
97148-39-5
Flam. Sol. 1
Details
232-989-1
9080-17-5
Skin Corr. 1B
Details
232-565-6
9000-90-2
Resp. Sens. 1
Details
A complex combination of hydrocarbons from the base-freed fraction obtained from the distillation of coal tar and boiling in the range of approximately 325°C to 365°C (617°F to 689°F). It contains predominantly anthracene and phenanthrene and their alkyl derivatives.
295-274-3
91995-14-1
Carc. 1B
Details
A complex combination of hydrocarbons from the distillation of anthracene obtained by the crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of 330°C to 350°C (626°F to 662°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-275-9
91995-15-2
Carc. 1B; Muta. 1B
C Carcinogenic (article 57a)
M Mutagen (article 57b)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous coal high temperature tar and boiling in the approximate range of 350°C to 360°C (662°F to 680°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-276-4
91995-16-3
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of approximately 290°C to 340°C (554°F to 644°F). It contains chiefly trinuclear aromatics and their dihydro derivatives.
295-278-5
91995-17-4
Carc. 1B; Muta. 1B
C Carcinogenic (article 57a)
M Mutagen (article 57b)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
The anthracene-rich solid obtained by the crystallization and centrifuging of anthracene oil. It is composed primarily of anthracene, carbazole and phenanthrene.
292-603-2
90640-81-6
Carc. 1B; Muta. 1B
C Carcinogenic (article 57a)
M Mutagen (article 57b)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
The oil remaining after the removal, by a crystallization process, of an anthracene-rich solid (anthracene paste) from anthracene oil. It is composed primarily of two, three and four membered aromatic compounds.
292-604-8
90640-82-7
Carc. 1B; Muta. 1B
C Carcinogenic (article 57a)
M Mutagen (article 57b)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
A complex combination of polycyclic aromatic hydrocarbons obtained from coal tar having an approximate distillation range of 300°C to 400°C (572°F to 752°F). Composed primarily of phenanthrene, anthracene and carbazole
292-602-7
90640-80-5
Carc. 1B
C Carcinogenic (article 57a)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
292-697-5
90989-41-6
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 (primarily C8) and can contain nonaromatic hydrocarbons, both boiling in the range of approximately 130°C to 200°C (266°F to 392°F).
297-401-8
93571-75-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
292-698-0
90989-42-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
295-279-0
91995-18-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
292-695-4
90989-39-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from the evaporation of solvent under vacuum from polymerized hydrocarbon resin. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C9 and boiling in the range of approximately 120°C to 215°C (248°F to 419°F).
295-281-1
91995-20-9
Carc. 1B; Muta. 1B
Details
292-694-9
90989-38-1
Carc. 1B; Muta. 1B
Details
295-551-9
92062-36-7
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons produced by the distillation of the products from a steam cracking process treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly greater than C10 and boiling in the range of approximately 150°C to 320°C (302°F to 608°F).
292-621-0
90640-98-5
Asp. Tox. 1
Details
202-199-1
92-87-5
Carc. 1A; Acute Tox. 4
Details
202-710-8
98-88-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
201-990-9
90-41-5
Carc. 2; Acute Tox. 4
Details
202-110-6
91-95-2
Carc. 1B; Muta. 2
Details
202-177-1
92-67-1
Carc. 1A; Acute Tox. 4
C Carcinogenic (article 57a)
Details
202-163-5
92-52-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
202-328-1
94-37-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
-
90568-23-3
R Toxic for reproduction (article 57c)
Details
232-572-4
9001-00-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Details
DBBT
402-210-1
99688-47-8
STOT RE 2; Skin Sens. 1
Details
202-496-6
96-29-7
Carc. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3; STOT SE 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
202-318-7
94-26-8
END Endocrine disrupting properties (Article 57(f) - human health)
Details
PIGMENTGELB 82 897
400-710-4
94612-72-3
Acute Tox. 4
Details
202-759-5
99-49-0
Skin Sens. 1
Details
232-734-4
9012-54-8
Resp. Sens. 1
Details
618-392-2
9004-70-0
Expl. 1.1
Details
213-666-4
999-81-5
Acute Tox. 4
Details
444-950-8
99464-83-2
Muta. 2; Skin Sens. 1
Details
304-236-8
94247-67-3
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
232-671-2
9004-07-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Details
213-308-7
935-79-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
Details
619-396-7
99129-21-2
Acute Tox. 4; Skin Sens. 1
Details
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
Details
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
Details
The oil remaining after removal by a crystallization process of acenaphthene from acenaphthene oil from coal tar. Composed primarily of naphthalene and alkylnaphthalenes.
292-606-9
90640-85-0
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillation of coal tar and boiling in the range of approximately 240°C to 280°C (464°F to 536°F). Composed primarily of acenaphthene, naphthalene and alkyl naphthalene.
292-605-3
90640-84-9
Carc. 1B
Details
202-704-5
98-82-8
Flam. Liq. 3; Carc. 1B; Asp. Tox. 1; STOT SE 3
Details
619-020-1
94361-06-5
Repr. 1B; Acute Tox. 3; STOT RE 2
Details
213-052-6
919-86-8
Acute Tox. 3
Details
202-327-6
94-36-0
Org. Perox. B; Eye Irrit. 2; Skin Sens. 1
Details
202-564-5
97-17-6
Acute Tox. 4
Details

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