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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 09 rujna 2024. Database contains 4821 unique substances/entries.
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428-650-4
153719-23-4
Repr. 2; Acute Tox. 4
428-630-5
-
Skin Sens. 1
428-410-9
67014-36-2
Acute Tox. 4; Skin Sens. 1
428-400-4
-
Eye Dam. 1
428-390-1
86393-34-2
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
H-604
428-350-3
93629-90-4
Muta. 2; Eye Dam. 1; Skin Sens. 1
428-340-9
238088-70-5
Skin Irrit. 2
428-330-4
2833-30-9
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
428-320-1
71308-16-2
Acute Tox. 4; Skin Sens. 1
BM 96.0258.HCL
428-290-8
120606-08-8
Acute Tox. 4; Eye Dam. 1

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