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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 listopada 2024. Database contains 4821 unique substances/entries.
Filter the list

-
-
P Parasites
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
208-764-9
541-02-6
yes
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
950-299-5
-
yes
236-881-5
13530-68-2
yes
show/hide
Dioctyltin dilaurate EC / List no: 222-883-3 | CAS no: 3648-18-8
Stannane, dioctyl-, bis(coco acyloxy) derivs. EC / List no: 293-901-5 | CAS no: 91648-39-4
799-973-9
-
yes
235-702-8
12578-12-0
yes
-
-
P Parasites
-
-
P Parasites

Export search results to: