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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 23 srpnja 2024. Database contains 4821 unique substances/entries.
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202-467-8
95-95-4
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
202-464-1
95-92-1
Acute Tox. 4; Eye Irrit. 2
202-461-5
95-87-4
Acute Tox. 3; Skin Corr. 1B
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
202-453-1
95-80-7
yes
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
202-448-4
95-76-1
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
202-442-1
95-70-5
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
202-441-6
95-69-2
Carc. 1B; Muta. 2; Acute Tox. 3
202-439-5
95-65-8
Acute Tox. 3; Skin Corr. 1B

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