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 24 srpnja 2024. Database contains 4917 unique substances/entries.
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208-576-7
533-74-4
Acute Tox. 4; Eye Irrit. 2
Details
200-024-3
50-29-3
Carc. 2; Acute Tox. 3; STOT RE 1
Details
208-764-9
541-02-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
206-376-4
334-48-5
Skin Irrit. 2; Eye Irrit. 2
Details
-
1563-67-3
Acute Tox. 3
Details
258-256-6
52918-63-5
Acute Tox. 3
Details
211-666-9
682-80-4
Acute Tox. 2; Acute Tox. 3
Details
219-971-9
2587-90-8
Acute Tox. 2; Acute Tox. 3
Details
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2
Details
206-053-8
298-03-3
Acute Tox. 1; Acute Tox. 2
Details
212-758-1
867-27-6
Acute Tox. 3
Details
204-801-8
126-75-0
Acute Tox. 1; Acute Tox. 2
Details
213-052-6
919-86-8
Acute Tox. 3
Details
241-109-5
17040-19-6
Acute Tox. 3; Acute Tox. 4
Details
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Details
237-198-5
13684-56-5
Repr. 2
Details
213-800-1
1014-69-3
Acute Tox. 4
Details
204-424-9
120-78-5
Skin Sens. 1
Details
DIRECT BLUE 199
416-180-2
12222-04-7
Acute Tox. 4; STOT RE 2
Details
950-299-5
-
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
218-961-1
2303-16-4
Carc. 2; Acute Tox. 4
Details
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
Details
686-814-2
34363-01-4
Skin Irrit. 2; Skin Sens. 1
Details
204-697-4
124-40-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
204-697-4
124-40-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
Details

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