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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 04 listopada 2024. Database contains 4821 unique substances/entries.
Filter the list

-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
SYSTHANE TECHNICAL
410-400-0
88671-89-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
201-328-9
81-14-1
Carc. 2
248-505-7
27519-02-4
Skin Sens. 1B
-
-
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.
-
-
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.
205-628-0
144-41-2
Acute Tox. 3
239-213-0
15159-40-7
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
203-815-1
110-91-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
-
-
B Bacteria and similar species

Export search results to: