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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 listopada 2024. Database contains 4821 unique substances/entries.
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203-643-7
109-06-8
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
210-256-7
611-15-4
Acute Tox. 4
SUBSTANCE S123386; VANQUISH 100
420-590-7
4299-07-4
Skin Corr. 1B; Skin Sens. 1
AF-368
406-400-5
4595-26-0
STOT RE 2; Skin Irrit. 2; Skin Sens. 1
205-182-7
135-19-3
Acute Tox. 4
202-080-4
91-59-8
Carc. 1A; Acute Tox. 4
2-NAPHTHYLAMIN-6-SULFOMETHYLAMID; FAT 92'365/A
412-120-4
104295-55-8
STOT RE 2; Skin Sens. 1
2-NPP
410-360-4
5428-02-4
STOT RE 1; Acute Tox. 4; Skin Sens. 1
202-547-2
96-96-8
Acute Tox. 2; Acute Tox. 1; STOT RE 2
202-052-1
91-23-6
Carc. 1B; Acute Tox. 4

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