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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 13 rujna 2024. Database contains 4821 unique substances/entries.
Filter the list

605-037-1
156052-68-5
Skin Sens. 1
605-015-1
155569-91-8
Acute Tox. 3; STOT SE 1; STOT RE 1; Eye Dam. 1
604-715-4
149979-41-9
Carc. 2; Repr. 2
604-712-8
149961-52-4
Carc. 2; Repr. 2; Acute Tox. 4
604-636-5
148477-71-8
Carc. 1B; Repr. 2; STOT RE 2; Skin Sens. 1B
604-430-5
144651-06-9
STOT RE 2
604-398-2
144171-61-9
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
604-395-6
14409-72-4
yes
604-351-6
143390-89-0
Carc. 2
604-318-6
142891-20-1
Carc. 2; Skin Sens. 1

Export search results to: