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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 15 srpnja 2024. Database contains 4821 unique substances/entries.
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203-458-1
107-06-2
Flam. Liq. 2; Carc. 1B; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
203-977-3
112-49-2
Repr. 1B
yes
271-084-6
68515-42-4
Repr. 1B
yes
276-158-1
71888-89-6
Repr. 1B
yes
272-013-1
68648-93-1
yes
284-032-2
84777-06-0
Repr. 1B
yes
271-093-5
68515-50-4
Repr. 1B
yes
271-094-0
68515-51-5
yes
221-695-9
3194-55-6
Repr. 2; Lact.
yes
202-486-1
96-18-4
Carc. 1B; Repr. 1B; Acute Tox. 4
yes
253-242-6
36861-47-9
yes
701-394-3
1782069-81-1
yes
-
75166-30-2
yes
-
75166-31-3
yes
-
852541-25-4
yes
-
852541-30-1
yes
-
135821-74-8
yes
-
135821-03-3
yes
-
741687-98-9
yes
-
852541-21-0
yes
-
95342-41-9
yes

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