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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 02 listopada 2024. Database contains 4821 unique substances/entries.
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201-782-8
87-90-1
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
220-281-5
2699-79-8
Press. Gas; Acute Tox. 3; STOT RE 2
232-245-6
7791-25-5
Skin Corr. 1B; STOT SE 3
626-360-4
15244-35-6
yes
231-639-5
7664-93-9
Skin Corr. 1A
-
13451-08-6
Skin Corr. 1B
231-195-2
7446-09-5
Press. Gas; Acute Tox. 3; Skin Corr. 1B
234-129-0
10545-99-0
Skin Corr. 1B; STOT SE 3
204-482-5
121-57-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
226-218-8
5329-14-6
Eye Irrit. 2; Skin Irrit. 2

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