EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 19 srpnja 2024. Database contains 4821 unique substances/entries.
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204-679-6
124-09-4
Acute Tox. 4; STOT SE 3; Skin Corr. 1B
211-653-8
680-31-9
Carc. 1B; Muta. 1B
203-852-3
111-27-3
Acute Tox. 4
209-731-1
591-78-6
Flam. Liq. 3; Repr. 2; STOT RE 1; STOT SE 3
203-523-4
107-83-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
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Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
247-143-7
25637-27-8
Acute Tox. 4
PROCION EMERALD H-EXL COLOUR; SUBSTANCE S156718
417-250-5
151436-99-6
Eye Dam. 1; Skin Sens. 1
BRIGHTENER SM 1018 CONC.; LEUCOPHOR BCR
405-280-1
76508-02-6
Eye Irrit. 2
RED SF-PE 3534
410-180-6
157627-99-1
Eye Dam. 1
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
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
NATRIUMMETAWOLFRAMAT
412-770-9
12141-67-2
Acute Tox. 4; Eye Dam. 1
257-074-4
51235-04-2
Acute Tox. 4; Eye Irrit. 2
219-698-5
2499-95-8
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
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F Fungi
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F Fungi
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
STABO-FIX
405-030-1
148434-03-1
Carc. 1B; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
HNF; HYDRAZINIUM NITROFORMATE
414-850-9
4682-01-3
Expl. 1.1; Self-react. A; Carc. 1B; Acute Tox. 3; Skin Sens. 1
204-563-5
122-66-7
Carc. 1B; Acute Tox. 4
233-109-9
10034-85-2
Press. Gas; Skin Corr. 1A
233-109-9
10034-85-2
Skin Corr. 1B
233-113-0
10035-10-6
Skin Corr. 1B; STOT SE 3
233-113-0
10035-10-6
Press. Gas; Skin Corr. 1A; STOT SE 3
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
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
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
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
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
271-261-8
68527-19-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
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
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
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
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
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
305-971-7
95371-04-3
Carc. 1B
A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 16cSt at 40°C (104°F). It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C14 through C29 and boiling in the range of approximately 250°C to 425°C (482°F to 797°F).
307-760-5
97722-10-6
Carc. 1B
A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of a middle distillate with hydrogen. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C20 and boiling in the range of approximately 290°C to 350°C (554°F to 662°F). It produces a finished oil having a viscosity of 2cSt at 100°C (212°F).
307-659-6
97675-85-9
Carc. 1B
A complex combination of hydrocarbons obtained by solvent dewaxing of a distillation residue from a hydrocracked paraffinic distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C20 and boiling in the range of approximately 360°C to 500°C (680°F to 932°F). It produces a finished oil having a viscosity of 4.5cSt at approximately 100°C (212°F).
307-662-2
97675-88-2
Carc. 2
305-972-2
95371-05-4
Carc. 1B
308-132-3
97862-82-3
Carc. 1B
A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of a solvent-deasphalted short residue with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C30 and boiling in the range of approximately 300°C to 400°C (572°F to 752°F). It produces a finished oil having a viscosity of 4cSt at approximately 100°C (212°F).
307-661-7
97675-87-1
Carc. 1B

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