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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 16 rujna 2024. Database contains 4821 unique substances/entries.
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210-467-4
616-20-6
Flam. Liq. 2; Acute Tox. 4
203-582-6
108-43-0
Acute Tox. 4
203-457-6
107-05-1
Flam. Liq. 2; Carc. 2; Muta. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
CHLOROFORMIATE DE CHLORO 3 PROPYLE
425-770-9
628-11-5
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
203-580-5
108-41-8
Acute Tox. 4
ISOPHORONENITRILE, IPN
411-490-4
7027-11-4
Acute Tox. 4; STOT RE 2; Skin Sens. 1
SANDUVOR 3056
411-920-0
106917-30-0
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1A
UK-48,340
425-820-1
88150-42-9
Acute Tox. 3; STOT RE 2; Eye Dam. 1
ZOLDINE MS-PLUS
421-150-7
143860-04-2
Repr. 1B; Skin Corr. 1B
yes
210-187-2
609-26-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3

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