EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database 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).

RELEVANT LEGISLATION
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EU CLP (1272/2008)
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1

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Group members
This group of substance has the following member substances:
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Name EC / List no. CAS no. Association
Proteinase, Serratia extracellular 253-457-5 37312-62-2 Expert judgement
Proteinase, Bacillus neutral 278-547-1 76774-43-1 Expert judgement
Proteinase, Bacillus subtilis serine 266-557-9 67051-83-6 Expert judgement
Aspergillin M - 42615-60-1 Expert judgement
Proteinase, Staphylococcus aureus serine 259-611-8 55354-32-0 Expert judgement
Proteinase, bacterial E 30 serine - 39369-34-1 Expert judgement
Proteinase, Bacillus licheniformis serine 279-361-3 79986-26-8 Expert judgement
Amylase, mixed with proteinase, Bacillus thuringiensis-fermented - 68909-36-4 Expert judgement
Proteinase, Endothia aspartic 253-395-9 37205-60-0 Expert judgement
Proteinase, microbial alkaline 256-863-0 50936-53-3 Expert judgement
Proteinase, Aspergillus niger neutral 254-422-7 39346-39-9 Expert judgement
Myxobacteralphalyticproteinase - 12585-31-8 Expert judgement
Amylase, mixed with proteinase, Bacillus cereus-fermented - 68909-35-3 Expert judgement
Proteinase, Aspergillus melleus, semialkaline - 76106-83-7 Expert judgement
Proteinase, pancreatic 232-626-7 9001-72-3 Expert judgement
Proteinase, Bacillus subtilis metallo- 232-991-2 9080-56-2 Expert judgement
Bacillus megaterium protease fermentation product - 68909-17-1 Expert judgement
Proteinase, Bacillus alcalophilus serine 306-090-0 95979-76-3 Expert judgement
Proteinase, submandibular gland serine, A 279-893-6 82047-85-6 Expert judgement
Proteinase, Aspergillus acid 232-796-2 9025-49-4 Expert judgement
Proteinase, Streptomyces griseus 232-909-5 9036-06-0 Expert judgement
Proteinase, rhizopus acid 812-486-9 9074-09-3 Expert judgement
Proteinase, serine (Tritirachium album) 686-165-5 102925-54-2 Expert judgement
Proteinase, Mucor aspartic 232-975-5 9073-79-4 Expert judgement
Proteinase, Myxobacter α-lytic 253-448-6 37288-76-9 Expert judgement
Proteinase, Bacillus alkaline 232-972-9 9073-77-2 Expert judgement
Proteinase, Bacillus subtilis 257-520-8 51931-23-8 Expert judgement
Proteinase, Agkistrodon serine 232-933-6 9046-56-4 Expert judgement
Proteinase, aspartic 278-856-1 78169-47-8 Expert judgement
Proteinase, microbial acid 256-862-5 50936-52-2 Expert judgement
Proteinase, Tritirachium album serine 254-457-8 39450-01-6 Expert judgement
Proteinase, Aspergillus parasiticus neutral 254-418-5 39335-09-6 Expert judgement
Proteinase, oryzin 232-992-8 9081-30-5 Expert judgement
Proteinase, microbial neutral 232-966-6 9068-59-1 Expert judgement
Proteinase, Bacillus polymyxa neutral 255-914-4 42613-33-2 Expert judgement
Proteinase, Bacillus subtilis, sutilain 235-390-3 12211-28-8 Expert judgement
Proteinase, Aspergillus neutral 278-588-5 77000-13-6 Expert judgement
Bacteria, complex with amylase and proteinase - 68920-42-3 Expert judgement
Thrombin 232-648-7 9002-04-4 Expert judgement
Proteinase, serine 253-431-3 37259-58-8 Expert judgement
Proteinase, Aspergillus oryzae neutral 232-990-7 9080-55-1 Expert judgement
Proteinase, Bothrops atrox serine 232-918-4 9039-61-6 Expert judgement
Amylase, mixture with proteinase 685-079-5 9001-11-0 Expert judgement
Proteinase, Aspergillus alkaline 232-977-6 9074-07-1 Expert judgement
Proteinase, Myxobacter AL-1, II 276-716-4 72561-05-8 Expert judgement