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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 13 rujna 2024. Database contains 4821 unique substances/entries.
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BASIC YELLOW 105; C.I. BASIC YELLOW 105
405-860-4
121315-16-0
Skin Sens. 1
SPIRAMBRENE
416-930-9
121251-67-0
Skin Irrit. 2
235-186-4
12125-02-9
Acute Tox. 4; Eye Irrit. 2
235-185-9
12125-01-8
Acute Tox. 3
426-150-0
121246-28-4
Skin Sens. 1
235-180-1
12122-67-7
STOT SE 3; Skin Sens. 1
1-ETHOXY-2,3-DIFLUORBENZOL; 1-ETHOXY-2,3-DIFLUOROBENZENE; 2,3-DIFLUOROPHENETOL; DIPHOL
441-000-4
121219-07-6
Acute Tox. 4
AF-365
405-510-0
121216-78-2
Skin Irrit. 2; Skin Sens. 1
310-154-3
121158-58-5
yes
310-154-3
121158-58-5
yes
310-154-3
121158-58-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes
204-502-2
121-87-9
Acute Tox. 4
204-498-2
121-79-9
Acute Tox. 4; Skin Sens. 1
204-497-7
121-75-5
Acute Tox. 4; Skin Sens. 1
204-495-6
121-72-2
Acute Tox. 3; STOT RE 2
204-493-5
121-69-7
Carc. 2; Acute Tox. 3
204-482-5
121-57-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
204-473-6
121-47-1
Acute Tox. 4
204-469-4
121-44-8
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
204-468-9
121-43-7
Flam. Liq. 3; Acute Tox. 4
204-462-6
121-29-9
Acute Tox. 4
204-455-8
121-21-1
Acute Tox. 4
204-454-2
121-20-0
Acute Tox. 4
204-450-0
121-14-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
yes
MAGISTER* F ACARICIDAL CHEMICAL
410-580-0
120928-09-8
Acute Tox. 3; Acute Tox. 4
EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4
235-113-6
12069-69-1
Acute Tox. 4; Eye Irrit. 2
235-103-1
12068-61-0
Carc. 1A; STOT RE 1; Skin Sens. 1
235-067-7
12065-90-6
yes
BM 96.0258.HCL
428-290-8
120606-08-8
Acute Tox. 4; Eye Dam. 1
235-038-9
12060-00-3
yes
235-033-1
12059-14-2
Carc. 1A; STOT RE 1; Skin Sens. 1
235-023-7
12057-74-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
432-240-0
12056-51-8
Carc. 2
235-008-5
12054-48-7
Carc. 1A; Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
FLEXSORB HP SOLID; MALINE K
405-560-3
120447-91-8
Acute Tox. 4; Skin Corr. 1A
234-853-7
12036-76-9
yes
234-829-6
12035-72-2
Carc. 1A; Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
-
12035-71-1
Carc. 1A; Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
234-828-0
12035-64-2
Carc. 1A; STOT RE 1; Skin Sens. 1
234-825-4
12035-39-1
Carc. 1A; STOT RE 1; Skin Sens. 1
234-824-9
12035-38-0
Carc. 1A; STOT RE 1; Skin Sens. 1
234-823-3
12035-36-8
Carc. 1A; STOT RE 1; Skin Sens. 1
620-400-4
12031-65-1
Carc. 1A; STOT RE 1; Skin Sens. 1
P3B
418-080-4
120307-06-4
Skin Sens. 1
TRUSOPT INTERMEDIATE, L-686,771
415-030-3
120298-38-6
Skin Sens. 1
LICHTSCHUTZMITTEL 2577
407-600-5
120187-29-3
Muta. 2
CLEARFRAC J508B
426-210-6
120086-58-0
Skin Corr. 1B
234-541-0
12008-41-2
Repr. 1B
yes
234-495-1
12007-02-2
Carc. 1A; STOT RE 1; Skin Sens. 1

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