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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 srpnja 2024. Database contains 4821 unique substances/entries.
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65229-23-4
Carc. 1A; STOT RE 1; Skin Sens. 1
234-493-0
12007-00-0
Carc. 1A; STOT RE 1; Skin Sens. 1
235-723-2
12619-90-8
Carc. 1A; STOT RE 1; Skin Sens. 1
238-753-4
14708-14-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
237-396-1
13770-89-3
Carc. 1A; Muta. 2; Repr. 1B; Acute Tox. 4; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-511-8
14507-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
284-349-6
84852-37-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
242-522-3
18718-11-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
254-642-3
39819-65-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
223-463-2
3906-55-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
224-699-9
4454-16-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77900.
271-853-6
68610-24-2
Carc. 1A; STOT RE 1; Skin Sens. 1
248-169-1
27016-75-7
Carc. 1A; STOT RE 1; Skin Sens. 1
239-086-1
14998-37-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
258-051-1
52625-25-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
240-841-2
16812-54-7
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
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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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F Fungi
254-875-0
40292-82-8
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
257-447-1
51818-56-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
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B Bacteria and similar species
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B Bacteria and similar species
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P Parasites
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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.
A complex combination of hydrocarbons separated and/or condensed from natural gas during transportation and collected at the wellhead and/or from the production, gathering, transmission, and distribution pipelines in deeps, scrubbers, etc. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C2 through C8.
272-896-3
68919-39-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons separated as a liquid from natural gas in a surface separator by retrograde condensation. It consists mainly of hydrocarbons having carbon numbers predominantly in the range of C2 to C20. It is a liquid at atmospheric temperature and pressure.
265-047-3
64741-47-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons separated as a liquid from natural gas in a gas recycling plant by processes such as refrigeration or absorption. It consists mainly of saturated aliphatic hydrocarbons having carbon numbers in the range of C2 through C8.
265-048-9
64741-48-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
205-073-4
132-67-2
Acute Tox. 4
A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-180-7
64742-76-3
Carc. 1B
A complex combination of hydrocarbons obtained by removing straight chain paraffin hydrocarbons as a solid by treatment with an agent such as urea. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil having a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-179-1
64742-75-2
Carc. 1B
A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-173-9
64742-69-4
Carc. 1B
A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-172-3
64742-68-3
Carc. 1B
215-657-0
1338-02-9
Flam. Liq. 3; Acute Tox. 4
202-049-5
91-20-3
Carc. 2; Acute Tox. 4
Refined, partly refined, or unrefined petroleum products produced by the distillation of natural gas. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C6 and boiling in the range of approximately 100°C to 200°C (212°F to 392°F).
232-443-2
8030-30-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90°C to 230°C (194°F to 446°F).
265-115-2
64742-15-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 80°C to 218°C (176°F to 424°F).
271-266-5
68527-26-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
295-432-1
92045-51-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by alkylation of butanes. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12, rich in isooctane, and boiling in the range of approximately 35°C to 210°C (95°F to 410°F).
295-430-0
92045-49-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced from the distillation of naphtha streams from various refinery processes. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 0°C to 230°C (25°F to 446°F).
272-186-3
68783-12-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C8 and boiling in the range of approximately 20°C to 130°C (68°F to 266°F).
309-976-5
101795-01-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of the products from a steam cracking process thereafter treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers in the range of C9 through C10 and boiling in the range of approximately 140°C to 200°C (284°F to 392°F).
292-637-8
90641-13-7
Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of products from a steam-cracking process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 130°C to 220°C(266°F to 428°F).
271-138-9
68516-20-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35°C to 190°C (95°F to 374°F).
265-086-6
64741-84-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
307-035-3
97488-96-5
Carc. 1B
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90°C to 230°C (194°F to 446°F).
265-095-5
64741-92-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately -20°C to 100°C (-4°F to 212°F).
272-206-0
68783-66-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C5, predominantly C5, and boiling in the range of approximately minus 10°C to 35°C (14°F to 95°F).
295-442-6
92045-60-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons from distillation of products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C4 through C8 and boiling in the range of approximately minus 10°C to 130°C (14°F to 266°F).
265-075-6
64741-74-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by subjecting a petroleum distillate from the high temperature thermal cracking of heavy oil fractions to a sweetening process to convert mercaptans. It consists predominantly of aromatics, olefins and saturated hydrocarbons boiling in the range of approximately 20°C to 100°C (68°F to 212°F).
295-447-3
92045-65-3
Carc. 1B; Muta. 1B; Asp. Tox. 1

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