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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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209-673-7
590-18-1
Flam. Gas 1; Press. Gas
204-015-5
112-90-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
253-242-6
36861-47-9
yes
281-291-3
83918-57-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
281-291-3
83918-57-4
Acute Tox. 4; Skin Sens. 1
205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
204-528-4
122-20-3
Eye Irrit. 2

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