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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 18 rujna 2024. Database contains 4821 unique substances/entries.
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202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
420-200-5
1379676-70-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
428-320-1
71308-16-2
Acute Tox. 4; Skin Sens. 1
201-289-8
80-54-6
Repr. 1B
yes
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2-(4-tert-butylbenzyl)propionaldehyde EC / List no: 201-289-8 | CAS no: 80-54-6
(2S)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-30-2
(2R)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-31-3
799-970-2
-
yes
TBPE
410-020-5
5406-86-0
Repr. 2; STOT RE 2; Eye Dam. 1
443-980-9
221215-20-9
Skin Sens. 1
7-ETHYLTRYPTOPHOL
431-020-1
41340-36-7
Acute Tox. 4; STOT RE 2
XU 40304.03L ANTIMICROBIAL
405-640-8
36362-09-1
STOT RE 2; Skin Irrit. 2; Eye Dam. 1

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