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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 22 April 2024. Database contains 4821 unique substances/entries.
Filter the list

DIPND-50-AL (META)
420-060-5
117663-11-3
Flam. Liq. 3; Org. Perox. D
208-792-1
541-73-1
Acute Tox. 4
202-491-9
96-23-1
Carc. 1B; Acute Tox. 3; Acute Tox. 4
1,3-DICHLOR-4-FLUORBENZOL; B-7
406-160-1
1435-48-9
Acute Tox. 4; STOT RE 2; Skin Irrit. 2
DCEMH
401-570-7
89415-87-2
Ox. Sol. 1; Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
208-826-5
542-75-6
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
DE 3
413-140-6
3459-83-4
Flam. Liq. 3
UTMS
414-180-7
10218-17-4
Acute Tox. 4; Skin Irrit. 2
202-776-8
99-65-0
Acute Tox. 2; Acute Tox. 1; STOT RE 2
211-463-5
646-06-0
Flam. Liq. 2

Export search results to: