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 17 srpnja 2024. Database contains 4917 unique substances/entries.
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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
A complex combination of hydrocarbons obtained by the fractionation pyrolysis at 816°C (1500°F) of naphtha and raffinate. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8, including benzene.
270-658-3
68475-70-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
292-697-5
90989-41-6
Carc. 1B; Muta. 1B
Details
268-618-5
68131-49-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-958-7
101794-76-7
Carc. 1B
Details
A complex combination hydrocarbons obtained from mixed coal tar pitch-polyethylene-polypropylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-956-6
101794-74-5
Carc. 1B
Details
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-957-1
101794-75-6
Carc. 1B
Details
201-706-3
86-88-4
Acute Tox. 2; Carc. 2
Details
215-175-0
1309-64-4
Carc. 2
Details
232-009-2
7783-56-4
Acute Tox. 3
Details
233-047-2
10025-91-9
Skin Corr. 1B
Details
231-601-8
7647-18-9
Skin Corr. 1B
Details
-
-
Acute Tox. 4
Details
201-549-0
84-65-1
Carc. 1B
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
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
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
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
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 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 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
204-371-1
120-12-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
200-539-3
62-53-3
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1
Details
202-910-5
101-05-3
Eye Irrit. 2; Skin Irrit. 2
Details
433-560-3
15375-21-0
Repr. 2
Details
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Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Amylase, gluco- EC / List no: 232-877-2 | CAS no: 9032-08-0
Amylase, α- EC / List no: 232-565-6 | CAS no: 9000-90-2
Amylase, fungal EC / List no: 232-742-8 | CAS no: 9013-01-8
Amylase, β- EC / List no: 232-566-1 | CAS no: 9000-91-3
Amylase, gluco-, Rhizopus oryzae EC / List no: - | CAS no: 152923-55-2
Amylase EC / List no: 232-567-7 | CAS no: 9000-92-4
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Amylase, iso- EC / List no: 232-956-1 | CAS no: 9067-73-6
Amylase, bacterial EC / List no: 232-560-9 | CAS no: 9000-85-5
Amylase, α-, Aspergillus oryzae EC / List no: 232-588-1 | CAS no: 9001-19-8
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Amylase, alpha-, Bacillus amyloliquefaciens EC / List no: - | CAS no: 152923-48-3
-
-
Resp. Sens. 1
Details
232-565-6
9000-90-2
Resp. Sens. 1
Details
223-320-4
3825-26-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
-
4149-60-4
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
221-037-0
2980-64-5
Acute Tox. 2; Acute Tox. 1; STOT RE 2
Details
232-989-1
9080-17-5
Skin Corr. 1B
Details
249-415-0
29081-56-9
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
Details
269-511-6
68259-08-5
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
228-098-2
6130-43-4
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
232-235-1
7790-98-9
Expl. 1.1; Ox. Sol. 1
Details
221-470-5
3108-42-7
Carc. 2; Repr. 1B; Lact.
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
235-185-9
12125-01-8
Acute Tox. 3
Details
232-143-1
7789-09-5
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
Details
235-186-4
12125-02-9
Acute Tox. 4; Eye Irrit. 2
Details
235-183-8
12124-97-9
Repr. 1B; Lact.; STOT SE 3; STOT RE 1; Eye Irrit. 2
Details
AIZEN SPILON BLACK TRH; AIZEN SPILON SCHWARZ TRH; THR-1; TRH
400-110-2
109125-51-1
Self-react. C
Details
215-676-4
1341-49-7
Acute Tox. 3; Skin Corr. 1B
Details
441-050-7
223705-57-5
Skin Irrit. 2; Eye Dam. 1
Details
700-242-3
62037-80-3
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
Details
640 AMMONIUM SALT; KSMIA; S-102; SMIA
405-990-1
97148-39-5
Flam. Sol. 1
Details
231-635-3
7664-41-7
Flam. Gas 2; Press. Gas; Acute Tox. 3; Skin Corr. 1B
Details
215-647-6
1336-21-6
Skin Corr. 1B
Details
200-521-5
61-82-5
Repr. 2; STOT RE 2
Details
251-375-4
33089-61-1
Acute Tox. 4; STOT RE 2; Skin Sens. 1
Details
672-776-4
348635-87-0
Carc. 2; Eye Irrit. 2
Details

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