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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 11 listopada 2024. Database contains 4821 unique substances/entries.
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203-804-1
110-80-5
Flam. Liq. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4
yes
203-839-2
111-15-9
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
239-622-4
15571-58-1
Repr. 1B; STOT RE 1
yes
201-963-1
90-04-0
Carc. 1B; Muta. 2; Acute Tox. 3
yes
203-713-7
109-86-4
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
203-772-9
110-49-6
Repr. 1B; Acute Tox. 4
yes
ACETOCURE 97; GENOCURE*PMP; IGM 4817; IRGACURE 907; SPEEDCURE 97
400-600-6
71868-10-5
Repr. 1B; Acute Tox. 4
yes
211-765-7
693-98-1
Repr. 1B
yes
687-833-9
1119449-38-5
yes
248-743-1
27942-27-4
yes

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