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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 lipnja 2024. Database contains 4821 unique substances/entries.
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235-688-3
12519-85-6
Carc. 1A; STOT RE 1; Skin Sens. 1
215-290-6
1319-46-6
yes
231-205-5
7446-27-7
Repr. 1A; STOT RE 2
222-979-5
3687-31-8
yes
235-252-2
12141-20-7
yes
ACID BLUE FC 77890
414-290-5
149564-65-8
Acute Tox. 4
IJA-286; IJBK-286; IJBK-286-LI
403-650-7
117409-78-6
Expl. 1.3
220-449-8
2768-02-7
Skin Sens. 1B
204-468-9
121-43-7
Flam. Liq. 3; Acute Tox. 4
1,3-PDTA; AGENT CHELATANT KODAK NO.1; DISSOLVINE PDZ; HAMPSHIRE PDTA; KODAK CHELATING AGENT NO.1; TRILON R FS
400-400-9
1939-36-2
Acute Tox. 4; Eye Dam. 1

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