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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605-127-0
158062-67-0
Acute Tox. 4
Details
FLOCOUMAFEN
421-960-0
90035-08-8
Repr. 1B; Acute Tox. 1; 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
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B Bacteria and similar species
Details
424-610-5
120068-37-3
Acute Tox. 3; STOT RE 1
Details
232-599-1
9001-33-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Details
238-484-2
14484-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
200-990-6
76-87-9
Carc. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
212-984-0
900-95-8
Carc. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
200-231-9
55-38-9
Muta. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1
Details
204-114-3
115-90-2
Acute Tox. 1; Acute Tox. 2
Details
201-274-6
80-38-6
Acute Tox. 4; Eye Irrit. 2
Details
603-792-1
134098-61-6
Acute Tox. 3; Acute Tox. 2; Skin Sens. 1B
Details
266-719-9
67564-91-4
Repr. 2; Acute Tox. 4; Skin Irrit. 2
Details
254-485-0
39515-41-8
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
Details
276-696-7
72490-01-8
Carc. 2
Details
615-273-7
71283-80-2
STOT RE 2; Skin Sens. 1
Details
202-271-2
93-72-1
Acute Tox. 4; Skin Irrit. 2
Details
223-188-8
3766-81-2
Acute Tox. 4
Details
204-524-2
122-14-5
Acute Tox. 4
Details
206-082-6
299-84-3
Acute Tox. 4
Details
236-407-7
13356-08-6
Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
Details
MAGISTER* F ACARICIDAL CHEMICAL
410-580-0
120928-09-8
Acute Tox. 3; Acute Tox. 4
Details
238-134-9
14255-88-0
Acute Tox. 4
Details
262-095-7
60168-88-9
Repr. 2; Lact.
Details
244-848-1
22224-92-6
Acute Tox. 2; Eye Irrit. 2
Details
205-419-4
140-56-7
Acute Tox. 3; Acute Tox. 4
Details
294-785-9
91770-03-5
Skin Irrit. 2
Details
294-302-1
91697-41-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
447-880-6
206565-89-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
283-972-0
84776-45-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
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P Parasites
Details
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P Parasites
Details
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P Parasites
Details
603-520-1
131807-57-3
STOT RE 2
Details
The extract from coal tar oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
266-017-2
65996-83-0
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained as a fraction of the distillation of an extract from the solvent extraction of light paraffinic top petroleum distillates that is subjected to a sulfuric acid refining. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
295-339-6
91995-76-5
Carc. 1B
Details
A complex combination of hydrocarbons obtained as the extract from the re-extraction of solvent-refined heavy paraffinic distillate. It consists of saturated and aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50.
272-180-0
68783-04-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained from a solvent dewaxed petroleum stock by treating with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C50 and produces a finished oil with a viscosity of greater than 19cSt at 40°C.
297-829-5
93763-11-2
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oil treated with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
309-674-3
100684-04-6
Carc. 1B
Details
A complex combination of hydrocarbons, obtained by solvent extraction from light vacuum petroleum gas oils and treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
295-342-2
91995-79-8
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oils treated with bleaching earth for removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
309-675-9
100684-05-7
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent extraction from light vacuum petroleum gas oil. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
295-341-7
91995-78-7
Carc. 1B
Details
A complex combination of hydrocarbons produced by treating a light paraffinic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C26 and boiling in the range of approximately 280° to 400°C (536°F to 752°F).
292-633-6
90641-09-1
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent extraction of a light paraffin distillate and treated with hydrogen to convert the organic sulfur to hydrogen sulfide which is eliminated. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C40 and produces a finished oil with a viscosity of greater than 10cSt at 40°C.
295-340-1
91995-77-6
Carc. 1B
Details
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillates treated with bleaching earth to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-673-8
100684-03-5
Carc. 1B
Details
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillate treated with activated charcoal to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-672-2
100684-02-4
Carc. 1B
Details
A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C15 through C30. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-104-2
64742-05-8
Carc. 1B
Details
A complex combination of hydrocarbons obtained by treating the extract, obtained from a solvent extraction process, with hydrogen in the presence of a catalyst under conditions primarily to remove sulfur compounds. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C15 through C30. This stream is likely to contain 5 wt.% or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
295-338-0
91995-75-4
Carc. 1B
Details
A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C15 through C30. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-102-1
64742-03-6
Carc. 1B
Details

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