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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 srpnja 2024. Database contains 4821 unique substances/entries.
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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B Bacteria and similar species
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B Bacteria and similar species
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F Fungi
418-270-7
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Skin Sens. 1
414-910-4
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Eye Dam. 1; Skin Sens. 1
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B Bacteria and similar species
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yes
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Phenol, tetrapropylene- EC / List no: - | CAS no: 57427-55-1
Phenol, 4-dodecyl, branched EC / List no: 640-104-9 | CAS no: 210555-94-5
Phenol, dodecyl-, branched EC / List no: 310-154-3 | CAS no: 121158-58-5
Phenol, (tetrapropenyl) derivatives EC / List no: 616-100-8 | CAS no: 74499-35-7
[No public or meaningful name is available] EC / List no: - | CAS no: 27459-10-5
Phenol, 4-isododecyl- EC / List no: 608-055-8 | CAS no: 27147-75-7
799-972-3
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yes
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yes

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