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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 11 rujna 2024. Database contains 4821 unique substances/entries.
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428-260-4
-
Eye Dam. 1
428-230-0
79568-06-2
STOT RE 2
428-100-3
94239-04-0
Flam. Liq. 3; Acute Tox. 4
428-070-1
91788-83-9
STOT RE 1; Acute Tox. 4
428-050-2
-
Skin Sens. 1
428-040-8
138261-41-3
Acute Tox. 3
428-030-3
67914-69-6
Acute Tox. 4; STOT RE 2
428-020-9
6195-20-6
Skin Sens. 1
CP-166,221
428-010-4
82413-20-5
Carc. 2; Repr. 1B; Skin Sens. 1
427-930-3
250639-69-1
Skin Sens. 1

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