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 13 rujna 2024. Database contains 4917 unique substances/entries.
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232-064-2
7784-40-9
Carc. 1A; Repr. 1A; Acute Tox. 3; STOT RE 2
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.
215-693-7
1344-37-2
Carc. 1B; Repr. 1A; STOT RE 2
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
202-959-2
101-61-1
Carc. 1B
C Carcinogenic (article 57a)
Details
213-103-2
924-42-5
Carc. 1B; Muta. 1B; STOT RE 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
Details
202-429-0
95-53-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2
C Carcinogenic (article 57a)
Details
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-
C Carcinogenic (article 57a)
Details
256-418-0
49663-84-5
C Carcinogenic (article 57a)
Details
201-004-7
77-09-8
Carc. 1B; Muta. 2; Repr. 2
C Carcinogenic (article 57a)
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
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
Details

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