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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 15 listopada 2024. Database contains 4821 unique substances/entries.
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F7641; MTSI
410-550-7
79277-18-2
STOT RE 2; Resp. Sens. 1; Skin Sens. 1
A5546
402-050-2
59337-93-8
Skin Sens. 1
BROMBENZOAT; BROMOBENZOATE
410-310-1
70264-94-7
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
MAT 9460
414-080-3
117291-73-3
Acute Tox. 4
MAGME(R) 200 MONOMER
403-230-3
77402-05-2
Carc. 1B; Muta. 1B; Skin Corr. 1B; Skin Sens. 1
MAGME 100 MONOMEER
401-890-7
77402-03-0
Carc. 1B; Muta. 1B; Acute Tox. 4; Eye Irrit. 2
FAT 40'489
413-040-2
149850-30-6
Skin Sens. 1
414-460-9
105726-67-8
Acute Tox. 4
METHFAT
420-670-1
37443-42-8
Eye Dam. 1
F5384
401-340-6
83055-99-6
Skin Sens. 1

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