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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 20 rujna 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
205-282-0
137-17-7
Carc. 1B; Acute Tox. 3
-
21436-97-5
Carc. 1B; Acute Tox. 3
203-600-2
108-62-3
Flam. Sol. 2; Repr. 2; Acute Tox. 3
T3P
422-210-5
68957-94-8
Skin Corr. 1B
423-560-1
161717-32-4
Skin Sens. 1
203-614-9
108-77-0
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
201-795-9
88-06-2
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
204-639-8
123-63-7
Flam. Liq. 3
ESACURE TZT 100
403-150-9
954-16-5
Acute Tox. 4; Eye Irrit. 2

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