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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 28 svibnja 2024. Database contains 4821 unique substances/entries.
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208-164-7
513-49-5
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
BMS 187266-02; S-TIPAC
430-300-0
76932-17-7
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
441-070-6
61826-76-4
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
TRUSOPT INTERMEDIATE, L-686,771
415-030-3
120298-38-6
Skin Sens. 1
BENACTIVE GOLDEN YELLOW CN-GL; C.I. REACTIVE YELLOW 178; KAYACELON REACT GOLDEN YELLOW CN-GL; SOMAZIN GOLDEN YELLOW CN-GL
404-250-5
115099-55-3
Skin Sens. 1
CARTASOL TUERKIS K-ZBL KONC.; CARTASOL TURQUOISE K-JD 2336; CARTASOL TURQUOISE K-JD 2336 CONC.; CARTASOL TURQUOISE K-ZBL CONC.; CARTASOL TÜRKIS K-ZBL FLÜSSIG; CARTASOL TÜRKIS K-ZBL KONZ.; TURQUOISE CARTASOL K-JD 2336 CONC.
401-260-1
118800-27-4
Eye Irrit. 2
C.I. REAKTIV-BLAU 216; KAYACELON REACT BLUE CN-BL; KAYACELON REAKT-BLAU CN-BL; UBCNBL
404-670-9
89797-01-3
Skin Sens. 1
424-740-2
138271-16-6
Acute Tox. 4; Eye Dam. 1
233-195-8
10061-01-5
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
A-83851
410-780-8
1379676-72-8
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1

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