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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 listopada 2024. Database contains 4821 unique substances/entries.
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430-280-3
844491-96-9
Skin Sens. 1
430-250-1
406-58-6
Flam. Liq. 2
PTH-AA
430-230-0
136522-17-3
Acute Tox. 4
430-220-6
141942-85-0
Eye Irrit. 2
430-200-7
-
Eye Dam. 1
SP 7077
430-180-1
-
Skin Irrit. 2
430-170-5
114625-74-0
Acute Tox. 4
430-100-3
86978-24-7
Acute Tox. 4
430-090-0
205764-96-1
Eye Dam. 1; Skin Sens. 1
430-050-2
-
Skin Sens. 1

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