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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 18 lipnja 2024. Database contains 4821 unique substances/entries.
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419-620-1
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Skin Sens. 1
UK-103,449-BV
427-100-0
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
OA 8523
402-460-1
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Skin Irrit. 2; Skin Sens. 1
TFA-4713
418-960-8
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Skin Corr. 1B; Skin Sens. 1
444-320-2
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Acute Tox. 4
430-790-6
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
430-730-9
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Eye Dam. 1
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yes
430-580-4
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Skin Irrit. 2
424-660-8
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STOT RE 2; Eye Dam. 1; Skin Sens. 1

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