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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

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Last updated 28 March 2024. Database contains 4821 unique substances/entries.
Substance Name EC No. CAS No. EU CLP (1272/2008) EU_BA Directive 2000/54/EC EU REACH: List of SVHC
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Amylase, gluco-, Rhizopus oryzae EC / List no: - | CAS no: 152923-55-2
Amylase, α-, Aspergillus oryzae EC / List no: 232-588-1 | CAS no: 9001-19-8
Amylase, α- EC / List no: 232-565-6 | CAS no: 9000-90-2
Amylase, alpha-, Bacillus amyloliquefaciens EC / List no: - | CAS no: 152923-48-3
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Amylase, fungal EC / List no: 232-742-8 | CAS no: 9013-01-8
Amylase, iso- EC / List no: 232-956-1 | CAS no: 9067-73-6
Amylase EC / List no: 232-567-7 | CAS no: 9000-92-4
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Amylase, gluco- EC / List no: 232-877-2 | CAS no: 9032-08-0
Amylase, bacterial EC / List no: 232-560-9 | CAS no: 9000-85-5
Amylase, β- EC / List no: 232-566-1 | CAS no: 9000-91-3
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