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 22 svibnja 2024. Database contains 4917 unique substances/entries.
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241-010-7
16941-12-1
Acute Tox. 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
Details
204-127-4
116-15-4
Press. Gas; Acute Tox. 4; STOT SE 3
Details
256-356-4
48122-14-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
260-566-1
57110-29-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
243-072-0
19438-60-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
247-094-1
25550-51-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
235-921-9
13048-33-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
212-485-8
822-06-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
204-679-6
124-09-4
Acute Tox. 4; STOT SE 3; Skin Corr. 1B
Details
211-653-8
680-31-9
Carc. 1B; Muta. 1B
Details
203-852-3
111-27-3
Acute Tox. 4
Details
209-731-1
591-78-6
Flam. Liq. 3; Repr. 2; STOT RE 1; STOT SE 3
Details
247-143-7
25637-27-8
Acute Tox. 4
Details
257-074-4
51235-04-2
Acute Tox. 4; Eye Irrit. 2
Details
219-698-5
2499-95-8
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
206-114-9
302-01-2
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
C Carcinogenic (article 57a)
Details
204-563-5
122-66-7
Carc. 1B; Acute Tox. 4
Details
233-109-9
10034-85-2
Skin Corr. 1B
Details
233-109-9
10034-85-2
Press. Gas; Skin Corr. 1A
Details
233-113-0
10035-10-6
Press. Gas; Skin Corr. 1A; STOT SE 3
Details
233-113-0
10035-10-6
Skin Corr. 1B; STOT SE 3
Details
A complex combination of hydrocarbons having carbon numbers predominantly in the range of C1 through C3 and boiling in the range of approximately minus 164°C to minus 42°C (-263°F to -44°F).
271-259-7
68527-16-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
271-261-8
68527-19-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained by subjecting hydrocarbon gases to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4 and boiling in the range of approximately -164°C to -0.5°C(-263°F to 31°F).
271-038-5
68514-36-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons produced by thermal cracking and absorber operations and by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4 and boiling in the range of approximately minus 164°C to minus 0.5°C (-263°F to 31°F).
271-032-2
68514-31-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
270-689-2
68476-49-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
271-734-9
68606-25-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
270-687-1
68476-47-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by treating dewaxed heavy paraffinic distillate with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50.
292-617-9
90640-95-2
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillations of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C11 and boiling in a range approximately up to 204°C(400°F).
270-686-6
68476-46-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by distillation and condensation of crude oil. It consists of hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C3 through C4.
270-990-9
68512-91-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
270-681-9
68476-40-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
271-735-4
68606-26-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons produced by the distillation of the products of a steam cracking process. It consists predominantly of hydrocarbons having a carbon number of C4, predominantly 1-butene and 2-butene, containing also butane and isobutene and boiling in the range of approximately minus 12°C to 5°C (10.4°F to 41°F).
295-405-4
92045-23-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained from prehydrogenated cracked naphtha after distillative separation of benzene- and toluene-containing hydrocarbon cuts and a higher boiling fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately 30°C to 205°C (86°F to 401°F).
295-445-2
92045-63-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation from the product of a naphtha steam cracking process and subsequent catalytic selective hydrogenation of gum formers. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 30°C to 230°C (86°F to 446°F).
295-443-1
92045-61-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
270-682-4
68476-42-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained as first runnings from the depentanizer column before hydrotreatment of the aromatic charges. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C6, predominantly pentanes and pentenes, and boiling in the range of approximately 25°C to 40°C (77°F to 104°F).
295-298-4
91995-38-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
289-339-5
87741-01-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of nonaromatic hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35°C to 125°C (94°F to 257°F), benzene and toluene.
297-466-2
93572-36-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
270-695-5
68476-55-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.
297-852-0
93763-33-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by the sorption of benzene from a catalytically fully hydrogenated benzene-rich hydrocarbon cut that was distillatively obtained from prehydrogenated cracked naphtha. It consists predominantly of paraffinic and naphthenic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approximately 70°C to 100°C (158°F to 212°F).
295-446-8
92045-64-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of nonaromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 120°C to 210°C (248°F to 380°F) and C9 and higher aromatic hydrocarbons.
297-465-7
93572-35-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation from prehydrogenated cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C11 and boiling in the range of approximately 130°C to 205°C (266°F to 401°F).
295-444-7
92045-62-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by the distillation of a cut from the catalytic cracking process, having undergone an alkaline washing. It consists predominantly of hydrocarbons having carbon numbers in the range of C8 through C12 and boiling in the range of approximately 130°C to 210°C (266°F to 410°F).
295-794-0
92128-94-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.
297-853-6
93763-34-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.
297-854-1
93763-35-0
Asp. Tox. 1
Details
270-690-8
68476-50-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
297-857-8
93763-38-3
Carc. 1B
Details

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