EU-MEDICAL_DEVICES-ANX_I_7_8

Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Directive 93/42/EEC, 12 July 1993, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances in accordance with the Medical Devices Directive's (MDD) design and construction requirements pursuant to Annex I, Part II (7) & (8) (i.e., chemical, physical and biological properties; and infection and microbial contamination). 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). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

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Last updated 26 May 2022. Database contains 4753 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 melleus, semialkaline ecnumber: - | casnumber: 76106-83-7
Bacteria, complex with amylase and proteinase ecnumber: - | casnumber: 68920-42-3
Proteinase, Bothrops atrox serine ecnumber: 232-918-4 | casnumber: 9039-61-6
Proteinase, Bacillus polymyxa neutral ecnumber: 255-914-4 | casnumber: 42613-33-2
Proteinase, microbial alkaline ecnumber: 256-863-0 | casnumber: 50936-53-3
Proteinase, pancreatic ecnumber: 232-626-7 | casnumber: 9001-72-3
Myxobacteralphalyticproteinase ecnumber: - | casnumber: 12585-31-8
Proteinase, Endothia aspartic ecnumber: 253-395-9 | casnumber: 37205-60-0
Proteinase, Aspergillus alkaline ecnumber: 232-977-6 | casnumber: 9074-07-1
Thrombin ecnumber: 232-648-7 | casnumber: 9002-04-4
Bacillus megaterium protease fermentation product ecnumber: - | casnumber: 68909-17-1
Proteinase, Streptomyces griseus ecnumber: 232-909-5 | casnumber: 9036-06-0
Proteinase, serine (Tritirachium album) ecnumber: 686-165-5 | casnumber: 102925-54-2
Proteinase, Bacillus subtilis metallo- ecnumber: 232-991-2 | casnumber: 9080-56-2
Proteinase, Bacillus neutral ecnumber: 278-547-1 | casnumber: 76774-43-1
Proteinase, Myxobacter α-lytic ecnumber: 253-448-6 | casnumber: 37288-76-9
Proteinase, Aspergillus niger neutral ecnumber: 254-422-7 | casnumber: 39346-39-9
Proteinase, microbial acid ecnumber: 256-862-5 | casnumber: 50936-52-2
Proteinase, Tritirachium album serine ecnumber: 254-457-8 | casnumber: 39450-01-6
Proteinase, Aspergillus acid ecnumber: 232-796-2 | casnumber: 9025-49-4
Proteinase, Bacillus licheniformis serine ecnumber: 279-361-3 | casnumber: 79986-26-8
Proteinase, Staphylococcus aureus serine ecnumber: 259-611-8 | casnumber: 55354-32-0
Proteinase, aspartic ecnumber: 278-856-1 | casnumber: 78169-47-8
Proteinase, Bacillus subtilis, sutilain ecnumber: 235-390-3 | casnumber: 12211-28-8
Proteinase, submandibular gland serine, A ecnumber: 279-893-6 | casnumber: 82047-85-6
Amylase, mixture with proteinase ecnumber: 685-079-5 | casnumber: 9001-11-0
Proteinase, Myxobacter AL-1, II ecnumber: 276-716-4 | casnumber: 72561-05-8
Proteinase, oryzin ecnumber: 232-992-8 | casnumber: 9081-30-5
Proteinase, Agkistrodon serine ecnumber: 232-933-6 | casnumber: 9046-56-4
Proteinase, serine ecnumber: 253-431-3 | casnumber: 37259-58-8
Aspergillin M ecnumber: - | casnumber: 42615-60-1
Proteinase, Aspergillus oryzae neutral ecnumber: 232-990-7 | casnumber: 9080-55-1
Amylase, mixed with proteinase, Bacillus cereus-fermented ecnumber: - | casnumber: 68909-35-3
Proteinase, Bacillus subtilis ecnumber: 257-520-8 | casnumber: 51931-23-8
Proteinase, bacterial E 30 serine ecnumber: - | casnumber: 39369-34-1
Proteinase, Mucor aspartic ecnumber: 232-975-5 | casnumber: 9073-79-4
Proteinase, Aspergillus parasiticus neutral ecnumber: 254-418-5 | casnumber: 39335-09-6
Proteinase, Serratia extracellular ecnumber: 253-457-5 | casnumber: 37312-62-2
Proteinase, Aspergillus neutral ecnumber: 278-588-5 | casnumber: 77000-13-6
Proteinase, Bacillus alkaline ecnumber: 232-972-9 | casnumber: 9073-77-2
Proteinase, Bacillus subtilis serine ecnumber: 266-557-9 | casnumber: 67051-83-6
Proteinase, microbial neutral ecnumber: 232-966-6 | casnumber: 9068-59-1
Proteinase, Bacillus alcalophilus serine ecnumber: 306-090-0 | casnumber: 95979-76-3
Proteinase, rhizopus acid ecnumber: 812-486-9 | casnumber: 9074-09-3
934-013-6
9001-92-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1

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