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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 18 rujna 2024. Database contains 4821 unique substances/entries.
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602-927-1
123312-89-0
Carc. 2; Repr. 2
605-747-1
175013-18-0
Acute Tox. 3; Skin Irrit. 2
611-516-6
57369-32-1
Acute Tox. 4
610-007-6
422556-08-9
Skin Sens. 1
602-997-3
124495-18-7
Skin Sens. 1
604-398-2
144171-61-9
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
611-341-5
55965-84-9
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
620-370-2
2703-37-9
Acute Tox. 2; Acute Tox. 1
618-004-1
87392-12-9
Skin Sens. 1
617-100-0
8051-02-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2

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