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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 21 January 2022. Database contains 4812 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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Proteinase, Aspergillus oryzae neutral ecnumber: 232-990-7 | casnumber: 9080-55-1
Proteinase, Streptomyces griseus ecnumber: 232-909-5 | casnumber: 9036-06-0
Proteinase, pancreatic ecnumber: 232-626-7 | casnumber: 9001-72-3
Proteinase, Bacillus subtilis, sutilain ecnumber: 235-390-3 | casnumber: 12211-28-8
Proteinase, Endothia aspartic ecnumber: 253-395-9 | casnumber: 37205-60-0
Proteinase, Bacillus neutral ecnumber: 278-547-1 | casnumber: 76774-43-1
Proteinase, Bacillus polymyxa neutral ecnumber: 255-914-4 | casnumber: 42613-33-2
Myxobacteralphalyticproteinase ecnumber: - | casnumber: 12585-31-8
Proteinase, oryzin ecnumber: 232-992-8 | casnumber: 9081-30-5
Proteinase, Bacillus licheniformis serine ecnumber: 279-361-3 | casnumber: 79986-26-8
Proteinase, Aspergillus alkaline ecnumber: 232-977-6 | casnumber: 9074-07-1
Proteinase, Myxobacter α-lytic ecnumber: 253-448-6 | casnumber: 37288-76-9
Proteinase, Bacillus subtilis metallo- ecnumber: 232-991-2 | casnumber: 9080-56-2
Proteinase, Tritirachium album serine ecnumber: 254-457-8 | casnumber: 39450-01-6
Proteinase, Staphylococcus aureus serine ecnumber: 259-611-8 | casnumber: 55354-32-0
Proteinase, Aspergillus acid ecnumber: 232-796-2 | casnumber: 9025-49-4
Proteinase, microbial neutral ecnumber: 232-966-6 | casnumber: 9068-59-1
Proteinase, microbial alkaline ecnumber: 256-863-0 | casnumber: 50936-53-3
Thrombin ecnumber: 232-648-7 | casnumber: 9002-04-4
Proteinase, rhizopus acid ecnumber: 812-486-9 | casnumber: 9074-09-3
Proteinase, Bacillus subtilis serine ecnumber: 266-557-9 | casnumber: 67051-83-6
Aspergillin M ecnumber: - | casnumber: -
Proteinase, Aspergillus melleus, semialkaline ecnumber: - | casnumber: 76106-83-7
Proteinase, microbial acid ecnumber: 256-862-5 | casnumber: 50936-52-2
Proteinase, serine (Tritirachium album) ecnumber: 686-165-5 | casnumber: 102925-54-2
Proteinase, Aspergillus parasiticus neutral ecnumber: 254-418-5 | casnumber: 39335-09-6
Proteinase, bacterial E 30 serine ecnumber: - | casnumber: 39369-34-1
Proteinase, Bothrops atrox serine ecnumber: 232-918-4 | casnumber: 9039-61-6
Proteinase, Aspergillus neutral ecnumber: 278-588-5 | casnumber: 77000-13-6
Proteinase, Bacillus subtilis ecnumber: 257-520-8 | casnumber: 51931-23-8
Proteinase, serine ecnumber: 253-431-3 | casnumber: 37259-58-8
Proteinase, Myxobacter AL-1, II ecnumber: 276-716-4 | casnumber: 72561-05-8
Proteinase, Agkistrodon serine ecnumber: 232-933-6 | casnumber: 9046-56-4
Proteinase, Bacillus alkaline ecnumber: 232-972-9 | casnumber: 9073-77-2
Proteinase, Aspergillus niger neutral ecnumber: 254-422-7 | casnumber: 39346-39-9
Bacillus megaterium protease fermentation product ecnumber: - | casnumber: 68909-17-1
Proteinase, Serratia extracellular ecnumber: 253-457-5 | casnumber: 37312-62-2
Proteinase, aspartic ecnumber: 278-856-1 | casnumber: 78169-47-8
Proteinase, Mucor aspartic ecnumber: 232-975-5 | casnumber: 9073-79-4
Amylase, mixture with proteinase ecnumber: 685-079-5 | casnumber: 9001-11-0
Amylase, mixed with proteinase, Bacillus cereus-fermented ecnumber: - | casnumber: 68909-35-3
Proteinase, submandibular gland serine, A ecnumber: 279-893-6 | casnumber: 82047-85-6
Proteinase, Bacillus alcalophilus serine ecnumber: 306-090-0 | casnumber: 95979-76-3
Bacteria, complex with amylase and proteinase ecnumber: - | casnumber: 68920-42-3
934-013-6
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1

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