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 23 svibnja 2024. Database contains 4917 unique substances/entries.
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603-801-9
134237-50-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
-
-
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
Details
231-208-1
7446-70-0
Skin Corr. 1B
Details
240-877-9
16853-85-3
Water-react. 1; Skin Corr. 1A
Details
244-088-0
20859-73-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
Details
231-072-3
7429-90-5
Water-react. 2; Pyr. Sol. 1
Details
231-072-3
7429-90-5
Water-react. 2; Flam. Sol. 1
Details
209-090-8
555-31-7
Flam. Sol. 1
Details
604-314-4
142844-00-6
C Carcinogenic (article 57a)
Details
212-634-7
834-12-8
Acute Tox. 4
Details
-
919-76-6
Acute Tox. 4
Details
262-977-1
61788-46-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
Details
262-976-6
61788-45-2
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
Details
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
263-125-1
61790-33-8
Acute Tox. 4; Asp. Tox. 1; STOT RE 2; Skin Corr. 1B
Details
217-990-7
2032-59-9
Acute Tox. 3
Details
672-776-4
348635-87-0
Carc. 2; Eye Irrit. 2
Details
251-375-4
33089-61-1
Acute Tox. 4; STOT RE 2; Skin Sens. 1
Details
200-521-5
61-82-5
Repr. 2; STOT RE 2
Details
215-647-6
1336-21-6
Skin Corr. 1B
Details
231-635-3
7664-41-7
Flam. Gas 2; Press. Gas; Acute Tox. 3; Skin Corr. 1B
Details
640 AMMONIUM SALT; KSMIA; S-102; SMIA
405-990-1
97148-39-5
Flam. Sol. 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
441-050-7
223705-57-5
Skin Irrit. 2; Eye Dam. 1
Details
215-676-4
1341-49-7
Acute Tox. 3; Skin Corr. 1B
Details
AIZEN SPILON BLACK TRH; AIZEN SPILON SCHWARZ TRH; THR-1; TRH
400-110-2
109125-51-1
Self-react. C
Details
235-183-8
12124-97-9
Repr. 1B; Lact.; STOT SE 3; STOT RE 1; Eye Irrit. 2
Details
235-186-4
12125-02-9
Acute Tox. 4; Eye Irrit. 2
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
235-185-9
12125-01-8
Acute Tox. 3
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
232-235-1
7790-98-9
Expl. 1.1; Ox. Sol. 1
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
269-511-6
68259-08-5
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
249-415-0
29081-56-9
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
Details
232-989-1
9080-17-5
Skin Corr. 1B
Details
221-037-0
2980-64-5
Acute Tox. 2; Acute Tox. 1; STOT RE 2
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
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
232-565-6
9000-90-2
Resp. Sens. 1
Details
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Amylase, β- EC / List no: 232-566-1 | CAS no: 9000-91-3
Amylase, bacterial EC / List no: 232-560-9 | CAS no: 9000-85-5
Amylase, iso- EC / List no: 232-956-1 | CAS no: 9067-73-6
Amylase, fungal EC / List no: 232-742-8 | CAS no: 9013-01-8
Amylase, alpha-, Bacillus amyloliquefaciens EC / List no: - | CAS no: 152923-48-3
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, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Amylase, gluco-, Rhizopus oryzae EC / List no: - | CAS no: 152923-55-2
Amylase EC / List no: 232-567-7 | CAS no: 9000-92-4
Amylase, α- EC / List no: 232-565-6 | CAS no: 9000-90-2
Amylase, α-, Aspergillus oryzae EC / List no: 232-588-1 | CAS no: 9001-19-8
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
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-
Resp. Sens. 1
Details
433-560-3
15375-21-0
Repr. 2
Details
202-910-5
101-05-3
Eye Irrit. 2; Skin Irrit. 2
Details
200-539-3
62-53-3
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1
Details
204-371-1
120-12-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
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

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