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 19 srpnja 2024. Database contains 4917 unique substances/entries.
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A complex combination of hydrocarbons obtained from liqnite carbonization tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.
295-454-1
92045-71-1
Carc. 1B
Details
A complex combination of hydrocarbons obtained from liqnite carbonization tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process treated with hydrogen in the presence of a catalyst. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.
295-455-7
92045-72-2
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with activated carbon for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-296-6
97926-76-6
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with silicic acid for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-298-7
97926-78-8
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with bentonite for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-297-1
97926-77-7
Carc. 1B
Details
287-196-3
85422-92-0
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
A complex combination of hydrocarbons obtained from sulfur-containing paraffinic crude oil. It consists predominantly of a solvent refined deparaffinated lubricating oil with a viscosity of 65cSt at 50°C.
295-810-6
92129-09-4
Carc. 1B
Details
A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C).
265-176-5
64742-71-8
Carc. 1B
Details
A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C).
265-174-4
64742-70-7
Carc. 1B
Details
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F Fungi
Details
200-397-2
58-74-2
Acute Tox. 4
Details
232-627-2
9001-73-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Details
616-379-6
76738-62-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
Details
203-396-5
106-42-3
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
Details
UP 565
411-530-0
15024-10-9
Skin Sens. 1
Details
203-403-1
106-49-0
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
Details
203-180-0
104-15-4
Skin Corr. 1B
Details
203-180-0
104-15-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
203-404-7
106-50-3
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
Details
203-199-4
104-40-5
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
202-810-1
100-01-6
Acute Tox. 3; STOT RE 2
Details
202-795-1
99-86-5
Flam. Liq. 3; Acute Tox. 4; Skin Sens. 1; Asp. Tox. 1
Details
247-770-6
26543-97-5
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
203-398-6
106-44-5
Acute Tox. 3; Skin Corr. 1B
Details
203-405-2
106-51-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details

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