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 14 lipnja 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
HEXACONAZOLE
413-050-7
79983-71-4
Acute Tox. 4; Skin Sens. 1
Details
204-127-4
116-15-4
Press. Gas; Acute Tox. 4; STOT SE 3
Details
AMINAZA TOLFAMATATE
418-350-1
-
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
DIRECT RED 227, TETRAMETHYLAMMONIUM SALT
405-160-9
124537-30-0
Acute Tox. 3; Skin Sens. 1
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
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Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
Details
247-143-7
25637-27-8
Acute Tox. 4
Details
PROCION EMERALD H-EXL COLOUR; SUBSTANCE S156718
417-250-5
151436-99-6
Eye Dam. 1; Skin Sens. 1
Details
BRIGHTENER SM 1018 CONC.; LEUCOPHOR BCR
405-280-1
76508-02-6
Eye Irrit. 2
Details
RED SF-PE 3534
410-180-6
157627-99-1
Eye Dam. 1
Details
C.I. BLEU REACTIF 204; C.I. REACTIVE BLUE 204; REACTIVE BLUE 204; REAKTIV BLAU 204
400-050-7
85153-92-0
Resp. Sens. 1; Skin Sens. 1
Details
BRUN REACTIF 45; BRUNO REATTIVO 45; C.I. REACTIVE BROWN 45; CIBACROM BROWN 1347; CIBACRON BROWN 1347; REACTIVE BRAUN 45
401-650-1
85665-96-9
Skin Sens. 1
Details
NATRIUMMETAWOLFRAMAT
412-770-9
12141-67-2
Acute Tox. 4; Eye Dam. 1
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
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F Fungi
Details
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F Fungi
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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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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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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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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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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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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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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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
STABO-FIX
405-030-1
148434-03-1
Carc. 1B; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
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14913-74-7
Expl. 1.1; Self-react. A; Carc. 1B; Acute Tox. 3; Skin Sens. 1
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
The oil obtained from the heat treatment of a polyethylene/polypropylene mixture with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70°C to 120°C (158°F to 248°F).
309-745-9
100801-63-6
Carc. 1B; Muta. 1B
Details
The oil obtained from the heat treatment of polyethylene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of 70°C to 120°C (158°F to 248°F).
309-748-5
100801-65-8
Carc. 1B; Muta. 1B
Details
The oil obtained from the heat treatment of polystyrene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70°C to 210°C (158°F to 410°F).
309-749-0
100801-66-9
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by solvent extraction from a naphthenic distillate having a viscosity of 27cSt at 100°C (212°F). It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C26 through C55 and boiling in the range of approximately 395°C to 640°C (743°F to 1184°F).
307-753-7
97722-04-8
Carc. 1B
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
A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 2.2cSt at 40°C (104°F). It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C11 through C17 and boiling in the range of approximately 200°C to 300°C (392°F to 572°F).
307-757-9
97722-08-2
Carc. 1B
Details
A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of heavy paraffins with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 through C20 and boiling in the range of approximately 230°C to 350°C (446°F to 662°F). It produces a finished oil having a viscosity of 2cSt at 100°C (212°F).
307-660-1
97675-86-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 9.5cSt at 40°C (104°F). It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C13 through C27 and boiling in the range of approximately 240°C to 400°C (464°F to 752°F).
307-758-4
97722-09-3
Carc. 1B
Details
305-971-7
95371-04-3
Carc. 1B
Details

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