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 14 lipnja 2024. Database contains 4917 unique substances/entries.
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Acute Tox. 3
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Acute Tox. 3
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Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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425-210-3
169939-84-8
Skin Sens. 1
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C Carcinogenic (article 57a)
M Mutagen (article 57b)
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68583-35-7
B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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200-712-3
69-72-7
Repr. 2; Acute Tox. 4; Eye Dam. 1
Details
202-345-4
94-59-7
Carc. 1B; Muta. 2; Acute Tox. 4
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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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617-100-0
8051-02-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
618-004-1
87392-12-9
Skin Sens. 1
Details
243-193-9
19622-19-6
Acute Tox. 4
Details
249-013-5
28434-00-6
Acute Tox. 4
Details
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2635-50-9
Acute Tox. 3
Details
620-370-2
2703-37-9
Acute Tox. 2; Acute Tox. 1
Details
X4261
401-850-9
255881-94-8
PBT Persistent, Bioaccumulative and Toxic (article 57d)
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953-17-3
Acute Tox. 3
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ALKYL ISOCYANATE SILANE SCD 617
402-290-8
85702-90-5
Flam. Liq. 3; Resp. Sens. 1; Skin Sens. 1
Details
436-690-9
220727-26-4
Skin Sens. 1
Details
R-GLYCIDOL
404-660-4
57044-25-4
Self-react. C; Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
Details

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