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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 21 lipnja 2024. Database contains 4821 unique substances/entries.
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429-240-8
212652-59-0
Eye Dam. 1
427-710-7
215612-56-9
Eye Dam. 1; Skin Sens. 1
BLUE TZ 4312
423-770-3
-
Eye Dam. 1
SCARLET 12 04 262
406-820-9
159317-41-6
Eye Irrit. 2
SÄUREBLAU 82 226
402-500-8
104105-46-6
Eye Dam. 1
BROWN 1612969
407-110-1
480445-87-2
Eye Dam. 1; Skin Sens. 1
237-159-2
13674-87-8
Carc. 2
LEXMARK YELLOW DYE 415; PRISM YELLOW
406-073-9
131013-81-5
Acute Tox. 3
PIGMENTBLAU 1755
403-210-4
108300-90-9
Eye Dam. 1
247-759-6
26523-78-4
Skin Sens. 1
yes
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Tris(nonylphenyl) phosphite EC / List no: 247-759-6 | CAS no: 26523-78-4
Phenol, p-isononyl-, phosphite (3:1) EC / List no: - | CAS no: 31631-13-7
Phenol, 4-nonyl-, phosphite (3:1) EC / List no: 608-492-4 | CAS no: 3050-88-2
tris(4-nonylphenyl, branched) phosphite EC / List no: 701-028-2 | CAS no: -
Phenol, p-sec-nonyl-, phosphite EC / List no: - | CAS no: 106599-06-8
799-976-5
-
yes
213-934-0
1067-53-4
Repr. 1B
yes
204-118-5
115-96-8
Carc. 2; Repr. 1B; Acute Tox. 4
yes
ACETOACETYLORTHOSINIC ACID, A6-SALT
403-760-5
68030-79-5
Skin Sens. 1
-
7276-58-6
Acute Tox. 4
-
-
Acute Tox. 3
TRYPROPYLAMMONIUM DIHYDROGENPHOSPHAT
433-700-3
35687-90-2
Acute Tox. 4
-
-
Acute Tox. 3
442-960-7
332350-93-3
Acute Tox. 3; Eye Dam. 1
202-908-4
101-02-0
Eye Irrit. 2; Skin Irrit. 2
-
-
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
TZ 02508
413-320-4
869-59-0
STOT RE 1; Skin Irrit. 2
-
12137-12-1
Carc. 1A; STOT RE 1; Skin Sens. 1
234-829-6
12035-72-2
Carc. 1A; Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
234-495-1
12007-02-2
Carc. 1A; STOT RE 1; Skin Sens. 1

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