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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 06 rujna 2024. Database contains 4821 unique substances/entries.
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202-833-7
100-25-4
Acute Tox. 2; Acute Tox. 1; STOT RE 2
204-661-8
123-91-1
Flam. Liq. 2; Carc. 1B; Eye Irrit. 2; STOT SE 3
yes
221-641-4
3173-72-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
218-817-8
2243-62-1
Carc. 2
236-948-9
13560-89-9
yes
239-139-9
15087-24-8
yes
204-081-5
115-31-1
Acute Tox. 4
246-011-6
24083-03-2
Acute Tox. 4
201-162-7
78-96-6
Skin Corr. 1B
203-445-0
106-94-5
Flam. Liq. 2; Repr. 1B; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes

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