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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 srpnja 2024. Database contains 4821 unique substances/entries.
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R-GELB 2454
400-680-2
98181-47-6
Acute Tox. 4
REACTIVE RED 180 (HYDROLYSED)
423-200-3
98114-32-0
Eye Dam. 1; Skin Sens. 1
202-716-0
98-95-3
Carc. 2; Repr. 1B; Acute Tox. 3; STOT RE 1
yes
202-710-8
98-88-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
202-709-2
98-87-3
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
202-708-7
98-86-2
Acute Tox. 4; Eye Irrit. 2
202-705-0
98-83-9
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
202-704-5
98-82-8
Flam. Liq. 3; Asp. Tox. 1; STOT SE 3
202-696-3
98-73-7
Repr. 1B; STOT RE 1; Acute Tox. 4
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes

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