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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 16 rujna 2024. Database contains 4821 unique substances/entries.
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209-218-2
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561-41-1
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yes |
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202-027-5
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90-94-8
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Carc. 1B; Muta. 2; Eye Dam. 1 |
yes |
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B-TUM
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418-770-5
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151882-81-4
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Carc. 2 |
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207-762-5
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492-80-8
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Carc. 2; Acute Tox. 4; Eye Irrit. 2 |
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ZP-DK 2115
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407-590-2
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43151-99-1
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Acute Tox. 3; STOT RE 2; Skin Sens. 1 |
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202-974-4
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101-77-9
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Carc. 1B; Muta. 2; STOT SE 1; STOT RE 2; Skin Sens. 1 |
yes |
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AROCY L-10
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405-740-1
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47073-92-7
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Acute Tox. 4; STOT RE 2; Eye Dam. 1 |
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420-530-1
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177027-34-8
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Resp. Sens. 1; Skin Sens. 1 |
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AROCY M-10
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405-790-4
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101657-77-6
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Skin Sens. 1 |
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243-420-1
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19900-65-3
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Carc. 2; Acute Tox. 4 |
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