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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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440-510-4
-
Eye Dam. 1; Skin Sens. 1
440-480-2
341026-59-3
Eye Dam. 1; Skin Sens. 1
440-460-3
252579-81-0
Eye Irrit. 2
440-030-5
338735-71-0
Skin Irrit. 2; Eye Dam. 1
439-540-0
-
Skin Irrit. 2; Skin Sens. 1
439-500-2
33831-83-3
Acute Tox. 4; Skin Irrit. 2
439-360-2
142877-45-0
Skin Irrit. 2; Eye Dam. 1
438-670-5
87199-17-5
Skin Sens. 1
438-310-7
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Self-react. C; Repr. 2; Acute Tox. 4; STOT RE 2
437-720-3
227085-51-0
Eye Dam. 1

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