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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268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
233-402-1
10141-05-6
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
442-750-5
113066-89-0
Carc. 1A; Acute Tox. 2; STOT RE 1; Skin Sens. 1
Details
261-346-8
58591-45-0
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77332.
269-051-6
68186-89-0
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
215-154-6
1307-96-6
Acute Tox. 4; Skin Sens. 1
Details
233-334-2
10124-43-3
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
215-273-3
1317-42-6
Skin Sens. 1
Details
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-
F Fungi
Details
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
Details
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
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
SUBSTANCE S171393
427-390-9
-
Skin Sens. 1
Details
INDULIN MQK-1M
413-770-1
-
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
ALLYL SUCROSE
419-640-0
68784-14-5
Acute Tox. 4
Details
231-842-9
7758-89-6
Acute Tox. 4
Details
243-815-9
20427-59-2
Acute Tox. 2; Acute Tox. 4; Eye Dam. 1
Details
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-
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
Details
231-847-6
7758-98-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Details
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
Details
235-113-6
12069-69-1
Acute Tox. 4; Eye Irrit. 2
Details
KUPFER-II-METHANSULFONAT; KUPFERMETHANSULFONAT
405-400-2
54253-62-2
Acute Tox. 4; Eye Dam. 1
Details
204-810-7
126-90-9
Skin Sens. 1B
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

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