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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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202-635-0
98-08-8
Flam. Liq. 2
202-634-5
98-07-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
226-009-1
5216-25-1
Carc. 1B; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
605-037-1
156052-68-5
Skin Sens. 1
231-176-9
7440-67-7
Water-react. 1; Pyr. Sol. 1
231-176-9
7440-67-7
Self-heat. 1
936-037-2
-
yes
205-288-3
137-30-4
Acute Tox. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1; Skin Sens. 1
235-180-1
12122-67-7
STOT SE 3; Skin Sens. 1
417-130-2
1379689-21-0
Eye Dam. 1

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