EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1
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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 07 listopada 2024. Database contains 4821 unique substances/entries.
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202-052-1
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91-23-6
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Carc. 1B; Acute Tox. 4 |
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201-993-5
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90-43-7
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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202-705-0
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98-83-9
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Flam. Liq. 3; Eye Irrit. 2; STOT SE 3 |
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202-109-0
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91-94-1
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Carc. 1B; Acute Tox. 4; Skin Sens. 1 |
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202-448-4
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95-76-1
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Acute Tox. 3; Eye Dam. 1; Skin Sens. 1 |
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202-439-5
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95-65-8
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Acute Tox. 3; Skin Corr. 1B |
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ADK STAB AO 80; SUMILIZER GA-80
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410-730-5
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90498-90-1
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Acute Tox. 4 |
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424-530-0
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93076-03-0
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Acute Tox. 3; STOT SE 2; STOT RE 2; Eye Dam. 1; Skin Sens. 1 |
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620-041-3
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907204-31-3
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Lact. |
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IMEXINE FAE
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403-440-5
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93633-79-5
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Acute Tox. 4 |
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