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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 04 listopada 2024. Database contains 4821 unique substances/entries.
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243-105-9
19485-03-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
205-138-7
134-32-7
Acute Tox. 4
201-969-4
90-15-3
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
203-544-9
108-03-2
Flam. Liq. 3; Acute Tox. 4
N-N-OCTYLCAPROLACTAM; N-OCTYLCAPROLACTAME
420-040-6
59227-88-2
Skin Corr. 1B; Skin Sens. 1
200-752-1
71-41-0
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
TUPH
424-620-1
13909-63-2
Acute Tox. 4; STOT RE 2
202-155-1
92-43-3
Acute Tox. 4
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B

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