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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 srpnja 2024. Database contains 4821 unique substances/entries.
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DMBA
424-090-1
10097-02-6
Eye Dam. 1
430-580-4
-
Skin Irrit. 2
233-539-7
10222-01-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
PERMACHEM N21
412-380-9
69094-18-4
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Skin Sens. 1
426-850-6
2032-75-9
Flam. Liq. 3; Skin Corr. 1A; Acute Tox. 4; Skin Sens. 1
-
7076-53-1
Acute Tox. 3
N,N DIMETHYL DIETHOXY-2,2 ACETAMIDE
449-950-1
34640-92-1
Eye Irrit. 2
ROMILAT
415-610-6
104468-21-5
Skin Irrit. 2
2,3-ISOPROPYLIDENE DIOXYPHENOL
400-900-7
22961-82-6
Eye Dam. 1
200-906-8
75-83-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3

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