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 23 travnja 2024. Database contains 4917 unique substances/entries.
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310-154-3
121158-58-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
310-154-3
121158-58-5
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
310-154-3
121158-58-5
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
608-492-4
3050-88-2
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
640-104-9
210555-94-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
701-107-1
1801269-77-1
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
Details
701-105-0
1801269-80-6
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
Details
616-100-8
74499-35-7
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
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R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
218-892-7
2275-14-1
Acute Tox. 3
Details
Residue from the distillation of crude phenanthrene boiling in the approximate range of 340°C to 420°C (644°F to 788°F). It consists predominantly of phenanthrene, anthracene and carbazole.
310-169-5
122070-78-4
Carc. 1B
Details
201-581-5
85-01-8
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
A complex combination of hydrocarbons. It consists predominantly of aliphatic, alicyclic and aromatic hydrocarbons. It may also contain small amounts of nitrogen, oxygen and sulfur compounds. This category encompasses light, medium, and heavy petroleums, as well as the oils extracted from tar sands. Hydrocarbonaceous materials requiring major chemical changes for their recovery or conversion to petroleum refinery feedstocks such as crude shale oils, upgraded shale oils and liquid coal fuels are not included in this definition.
232-298-5
8002-05-9
Carc. 1B
Details
A complex combination which consists primarily of hydrogen with various small amounts of methane, ethane, and propane.
271-750-6
68607-11-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
The complex combination of hydrocarbons obtained in a hydrofiner-powerformer process and boiling in a range of approximately 27°C to 210°C (80°F to 410°F).
271-058-4
68514-79-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately -40°C to 80°C (-40°F to 176°F).
270-704-2
68476-85-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained by subjecting liquefied petroleum gas mix to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately -40°C to 80°C (-40°F to 176°F).
270-705-8
68476-86-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained by subjecting a liquified petroleum gas mix to a sweetening process to oxidize mercaptans or to remove acidic impurities. It consists predominantly of C4 saturated and unsaturated hydrocarbons.
295-463-0
92045-80-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained as a semi-solid from dewaxing paraffinic residual oil. It consists predominantly of saturated crystalline and liquid hydrocarbons having carbon numbers predominantly greater than C25.
232-373-2
8009-03-8
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C20.
308-150-1
97862-98-1
Carc. 1B
Details
A complex combination of organic compounds, predominantly high molecular weight carboxylic acids, obtained by the air oxidation of petrolatum.
265-206-7
64743-01-7
Carc. 1B
Details
A complex combination of hydrocarbons obtained as a semi-solid from dewaxed paraffinic residual oil treated with hydrogen in the presence of a catalyst. It consists predominantly of saturated microcrystalline and liquid hydrocarbons having carbon numbers predominantly greater than C20.
295-459-9
92045-77-7
Carc. 1B
Details
A complex combination of hydrocarbons obtained by treatment of petrolatum with bleaching earth for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of greater than C25.
309-706-6
100684-33-1
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C20.
308-149-6
97862-97-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained when petrolatum is treated with Al2O3 to remove polar components and impurities. It consists predominantly of saturated, crystalline, and liquid hydrocarbons having carbon numbers predominantly greater than C25.
285-098-5
85029-74-9
Carc. 1B
Details
600-765-6
106700-29-2
Acute Tox. 4; Skin Sens. 1
Details
258-067-9
52645-53-1
Acute Tox. 4; Skin Sens. 1
Details
206-397-9
335-67-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
217-179-8
1763-23-1
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
Details
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21049-39-8
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
206-801-3
375-95-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
206-587-1
355-46-4
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
206-798-9
375-85-9
Repr. 1B; STOT RE 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
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Ammonium perfluoroheptanoate EC / List no: 228-098-2 | CAS no: 6130-43-4
Perfluoroheptanoic acid EC / List no: 206-798-9 | CAS no: 375-85-9
Sodium perfluoroheptanoate EC / List no: 243-518-4 | CAS no: 20109-59-5
potassium perfluoroheptanoate EC / List no: - | CAS no: 21049-36-5
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R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
206-793-1
375-73-5
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
253-718-3
37924-13-3
Acute Tox. 4; Eye Irrit. 2
Details
231-512-4
7601-90-3
Ox. Liq. 1; Skin Corr. 1A
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
R Toxic for reproduction (article 57c)
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
R Toxic for reproduction (article 57c)
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
R Toxic for reproduction (article 57c)
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; STOT SE 3; Eye Dam. 1
Details
600-419-4
10332-33-9
R Toxic for reproduction (article 57c)
Details
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
600-611-8
10486-00-7
Repr. 1B; STOT SE 3; Eye Dam. 1
Details

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