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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 20 rujna 2024. Database contains 4821 unique substances/entries.
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202-436-9
95-63-6
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-433-2
95-57-8
Acute Tox. 4
202-431-1
95-55-6
Muta. 2; Acute Tox. 4
202-430-6
95-54-5
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
202-429-0
95-53-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2
yes
202-425-9
95-50-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-424-3
95-49-8
Acute Tox. 4
202-423-8
95-48-7
Acute Tox. 3; Skin Corr. 1B
202-422-2
95-47-6
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
202-411-2
95-33-0
Skin Sens. 1

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