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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 10 rujna 2024. Database contains 4821 unique substances/entries.
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209-474-5
581-89-5
Carc. 1B
201-209-1
79-46-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 4
201-853-3
88-72-2
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 4
204-589-7
122-99-6
Acute Tox. 4; STOT SE 3; Eye Dam. 1
1,3-PPD
411-810-2
1570-95-2
Eye Dam. 1
2-PHENYLETHYLISOCYANAT; 2-PHENYLETHYLISOCYANATE; PHENYL ETHYL ISOCYANATE
413-080-0
1943-82-4
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
SALICYNALVA
423-460-8
3508-98-3
Acute Tox. 4
201-993-5
90-43-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-705-0
98-83-9
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
2-ADPS
413-030-8
1134-94-7
Skin Sens. 1

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