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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 02 listopada 2024. Database contains 4821 unique substances/entries.
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229-879-0
6804-07-5
Flam. Sol. 1; Carc. 1B; Acute Tox. 4
200-555-0
63-25-2
Carc. 2; Acute Tox. 4
211-128-3
630-08-0
Flam. Gas 1; Press. Gas; Repr. 1A; Acute Tox. 3; STOT RE 1
228-200-5
6164-98-3
Carc. 2; Acute Tox. 4
200-663-8
67-66-3
Carc. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
264-409-8
63681-54-9
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
PD 133602-2
417-430-3
63645-17-0
Acute Tox. 3; STOT RE 2; Skin Sens. 1
A complex combination of hydrocarbons produced as the residual fraction from distillation of the products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-064-6
64741-62-4
Carc. 1B
A complex combination of hydrocarbons obtained by treating catalytic cracked clarified oil with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
269-782-0
68333-26-6
Carc. 1B
268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77332.
269-051-6
68186-89-0
Carc. 1A; STOT RE 1; Skin Sens. 1
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
ALLYL SUCROSE
419-640-0
68784-14-5
Acute Tox. 4
-
68583-16-4
B Bacteria and similar species
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic hydrocarbons and may contain appreciable quantities of tar acids and tar bases. It distills at the approximate range of 200°C to 325°C (392°F to 617°F).
263-047-8
61789-28-4
Carc. 1B
200-636-0
66-81-9
Muta. 2; Repr. 1B; Acute Tox. 2
227-964-7
6053-68-5
Eye Irrit. 2; STOT SE 3
269-855-7
68359-37-5
Acute Tox. 2; Acute Tox. 3
269-855-7
68359-37-5
Acute Tox. 2
274-050-9
69581-33-5
Acute Tox. 3; Acute Tox. 4
DEM
408-120-9
65197-96-8
Acute Tox. 4; Eye Dam. 1
211-666-9
682-80-4
Acute Tox. 2; Acute Tox. 3
210-937-9
626-23-3
Flam. Liq. 3; Acute Tox. 4
211-670-0
683-18-1
Muta. 2; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B
yes
200-547-7
62-73-7
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
200-632-9
66-76-2
STOT RE 1; Acute Tox. 4
200-484-5
60-57-1
Carc. 2; Acute Tox. 1; Acute Tox. 3; STOT RE 1
200-467-2
60-29-7
Flam. Liq. 1; Acute Tox. 4; STOT SE 3
200-589-6
64-67-5
Carc. 1B; Muta. 1B; Acute Tox. 4; Skin Corr. 1B
yes
211-000-7
627-44-1
Acute Tox. 2; Acute Tox. 1; STOT RE 2
270-877-4
68479-98-1
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
210-088-4
605-50-5
Repr. 1B
yes
211-617-1
674-82-8
Flam. Liq. 3; Acute Tox. 4
262-784-2
61432-55-1
Acute Tox. 4
200-480-3
60-51-5
Acute Tox. 4
432-310-0
617-55-0
Flam. Liq. 3; Eye Dam. 1; Skin Sens. 1
210-478-4
616-38-6
Flam. Liq. 2
210-871-0
624-92-0
Flam. Liq. 2; Acute Tox. 3; STOT SE 3; STOT SE 1; Eye Irrit. 2; Skin Sens. 1
200-549-8
62-75-9
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
-
63919-26-6
Acute Tox. 4
230-253-4
6988-21-2
Acute Tox. 3
229-912-9
6834-92-0
Skin Corr. 1B; STOT SE 3
The distillate from coal tar having an approximate distillation range of 220°C to 450°C (428°F to 842°F). Composed primarily of three to four membered condensed ring aromatic hydrocarbons and other hydrocarbons.
266-026-1
65996-91-0
Carc. 1B
The distillate from coal tar having an approximate distillation range of 100°C to 450°C (212°F to 842°F). Composed primarily of two to four membered condensed ring aromatic hydrocarbons, phenolic compounds, and aromatic nitrogen bases.
266-027-7
65996-92-1
Carc. 1B
The distillate from a mixture of coal tar and aromatic petroleum streams having an approximate distillation range of 220°C to 450°C (428°F to 842°F). Composed primarily of 3- to 4-membered condensed ring aromatic hydrocarbons.
269-159-3
68188-48-7
Carc. 1B
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 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.
265-117-3
64742-18-3
Carc. 1A
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid process. It consists predominantly of saturated 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).
265-119-4
64742-20-7
Carc. 1A
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 C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-118-9
64742-19-4
Carc. 1A
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity of less than 100 SUS at 100°F (19cSt at 40°C).
265-121-5
64742-21-8
Carc. 1A

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