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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 srpnja 2024. Database contains 4821 unique substances/entries.
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620-422-4
4097-36-3
Acute Tox. 3
620-419-8
606-35-9
Expl. 1.1; Acute Tox. 4
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
620-410-9
4234-79-1
Acute Tox. 3; Acute Tox. 4
620-404-6
7572-29-4
Unst. Expl.; Carc. 2; STOT RE 2
620-403-0
8003-05-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
620-400-4
12031-65-1
Carc. 1A; STOT RE 1; Skin Sens. 1
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
620-379-1
3254-63-5
Acute Tox. 1; Acute Tox. 2
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2

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