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 12 srpnja 2024. Database contains 4917 unique substances/entries.
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204-062-1
115-07-1
Flam. Gas 1; Press. Gas
Details
205-359-9
139-40-2
Carc. 2
Details
219-006-1
2312-35-8
Carc. 2; Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1
Details
211-914-6
709-98-8
Acute Tox. 4
Details
200-827-9
74-98-6
Flam. Gas 1; Press. Gas
Details
204-623-0
123-38-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
200-661-7
67-63-0
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
Details
200-746-9
71-23-8
Flam. Liq. 2; Eye Dam. 1; STOT SE 3
Details
217-638-2
1918-16-7
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
203-471-2
107-19-7
Flam. Liq. 3; Acute Tox. 3; Skin Corr. 1B
Details
220-113-0
2631-37-0
Acute Tox. 3
Details
604-105-8
139001-49-3
Carc. 2; Repr. 2; Skin Sens. 1
Details
247-656-6
26399-36-0
Eye Irrit. 2
Details
255-255-2
41198-08-7
Acute Tox. 4
Details
425-740-5
-
Eye Dam. 1
Details
BROWN JR 547
419-260-5
-
Eye Dam. 1
Details
266-994-5
67747-09-5
Acute Tox. 4
Details
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-
B Bacteria and similar species
Details
245-387-9
23031-36-9
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
ORANGE DER 8068
422-980-2
187026-95-5
Eye Dam. 1
Details
432-240-0
12056-51-8
Carc. 2
Details
425-830-4
-
Eye Dam. 1
Details
SUMIFIX BRILLIANTBLAU GL KONZENTRAT
414-100-0
154336-20-6
Eye Dam. 1
Details
C.I. REACTIVE RED 231
402-150-6
-
Eye Irrit. 2; Skin Sens. 1
Details

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