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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 lipnja 2024. Database contains 4821 unique substances/entries.
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B Bacteria and similar species
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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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yes
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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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Acute Tox. 4
435-650-8
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Acute Tox. 4; Skin Corr. 1A
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Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
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Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Amylase, β- EC / List no: 232-566-1 | CAS no: 9000-91-3
Amylase, α- EC / List no: 232-565-6 | CAS no: 9000-90-2
Amylase, bacterial EC / List no: 232-560-9 | CAS no: 9000-85-5
Amylase EC / List no: 232-567-7 | CAS no: 9000-92-4
Amylase, α-, Aspergillus oryzae EC / List no: 232-588-1 | CAS no: 9001-19-8
Amylase, alpha-, Bacillus amyloliquefaciens EC / List no: - | CAS no: 152923-48-3
Amylase, iso- EC / List no: 232-956-1 | CAS no: 9067-73-6
Amylase, gluco- EC / List no: 232-877-2 | CAS no: 9032-08-0
Amylase, fungal EC / List no: 232-742-8 | CAS no: 9013-01-8
Amylase, gluco-, Rhizopus oryzae EC / List no: - | CAS no: 152923-55-2
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
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Resp. Sens. 1
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P Parasites

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