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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 srpnja 2024. Database contains 4821 unique substances/entries.
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420-380-5
136465-81-1
Acute Tox. 4; Eye Dam. 1
444-350-6
133413-70-4
Eye Irrit. 2
PTH-AA
430-230-0
136522-17-3
Acute Tox. 4
17-KETOBROMOHYDRINE
419-790-7
4229-69-0
Skin Sens. 1
PHOTOAMORCEUR 22074; RHODORSIL PHOTOINITIATOR 2074; TEPBI
422-960-3
178233-72-2
Acute Tox. 4; STOT RE 2
SULPHONAMIDO-ANILINE
406-010-5
88918-84-7
Eye Dam. 1; Skin Sens. 1
247-162-0
25646-77-9
Acute Tox. 3; STOT RE 2; Skin Sens. 1
SILANEOPHAN
405-020-7
105024-66-6
Repr. 1B
SULPHAZINE
406-090-1
81880-96-8
Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
420-450-5
86552-32-1
Carc. 2; Eye Dam. 1

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