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 26 srpnja 2024. Database contains 4917 unique substances/entries.
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P Parasites
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P Parasites
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F Fungi
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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.
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217-617-8
1912-24-9
STOT RE 2; Skin Sens. 1
Details
200-104-8
51-55-8
Acute Tox. 2
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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
265-610-3
65195-55-3
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
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262-102-3
60207-31-0
Acute Tox. 4
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620-425-0
68049-83-2
Repr. 1B; STOT RE 2
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252-626-0
35575-96-3
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 1; Skin Sens. 1
Details
220-147-6
2642-71-9
Acute Tox. 2; Acute Tox. 3
Details
201-676-1
86-50-0
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
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203-102-5
103-33-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2
Details
255-209-1
41083-11-8
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
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227-419-3
5834-96-8
Acute Tox. 4
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207-802-1
495-48-7
Acute Tox. 4
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603-524-3
131860-33-8
Acute Tox. 3
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P Parasites
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P Parasites
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B Bacteria and similar species
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B Bacteria and similar species
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P Parasites
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202-930-4
101-27-9
Acute Tox. 4; Skin Sens. 1
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431-780-4
199876-46-5
Acute Tox. 4; STOT RE 2
Details

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