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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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228-871-4
6369-59-1
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
202-442-1
95-70-5
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
203-710-0
109-83-1
Acute Tox. 4; Skin Corr. 1B
200-878-7
75-55-8
Flam. Liq. 2; Carc. 1B; Acute Tox. 2; Acute Tox. 1; Eye Dam. 1
200-908-9
75-85-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
210-843-8
624-41-9
Flam. Liq. 3
252-343-2
35073-27-9
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
219-449-0
2438-20-2
Flam. Liq. 3
209-512-0
583-59-5
Acute Tox. 4
209-513-6
583-60-8
Flam. Liq. 3; Acute Tox. 4

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