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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 15 srpnja 2024. Database contains 4821 unique substances/entries.
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TICA 118
422-200-0
178277-55-9
Skin Corr. 1B; Acute Tox. 4
ETILEFRONE. HCL
401-840-4
55845-90-4
Eye Dam. 1
R-THP
415-110-8
54417-53-7
Acute Tox. 4
444-320-2
-
Acute Tox. 4
D-HPPA; HPOPS
407-960-3
94050-90-5
Eye Dam. 1
-
178961-20-1
Skin Sens. 1
430-560-5
180637-89-2
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
430-760-2
219861-18-4
Acute Tox. 4; Skin Sens. 1
226-908-9
5543-58-8
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
UK-111,975
422-390-5
143322-57-0
Repr. 2; STOT RE 1; Acute Tox. 4; Skin Sens. 1

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