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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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202-360-6
94-74-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
202-356-4
94-70-2
Acute Tox. 3; STOT RE 2
202-345-4
94-59-7
Carc. 1B; Muta. 2; Acute Tox. 4
202-328-1
94-37-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
202-327-6
94-36-0
Org. Perox. B; Eye Irrit. 2; Skin Sens. 1
202-318-7
94-26-8
yes
301-323-2
93983-68-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
301-312-2
93983-23-4
Eye Irrit. 2
425-370-4
93957-50-7
Skin Sens. 1
ACID BLUE 349; AZO-METALCOMPLEX-BLUE AP 1149; BLEU ACIDE 349; C.I. ACID BLUE 349; SELLASET BLEU H; SELLASET BLUE H
402-870-0
93952-24-0
Eye Dam. 1

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