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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 02 listopada 2024. Database contains 4821 unique substances/entries.
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203-468-6
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107-15-3
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Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1 |
yes |
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292-966-7
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91031-62-8
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yes |
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205-912-4
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206-44-0
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yes |
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500-036-1
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25214-70-4
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yes |
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300-298-5
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93925-00-9
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yes |
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200-842-0
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75-12-7
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Repr. 1B |
yes |
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203-727-3
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110-00-9
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Flam. Liq. 1; Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2 |
yes |
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603-804-5
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134237-52-8
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yes |
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203-856-5
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111-30-8
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Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1A |
yes |
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218-165-4
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2058-94-8
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yes |
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