EU-IMPLANTABLE_MEDICAL_DEVICES-ART_3_ANX_1

Active Implantable Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Directive 90/385/EEC on Active Implantable Medical Devices, 20 July 1990, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This 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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 27 January 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, Serratia extracellular ecnumber: 253-457-5 | casnumber: 37312-62-2
Proteinase, Myxobacter α-lytic ecnumber: 253-448-6 | casnumber: 37288-76-9
Bacteria, complex with amylase and proteinase ecnumber: - | casnumber: 68920-42-3
Proteinase, Streptomyces griseus ecnumber: 232-909-5 | casnumber: 9036-06-0
Proteinase, oryzin ecnumber: 232-992-8 | casnumber: 9081-30-5
Thrombin ecnumber: 232-648-7 | casnumber: 9002-04-4
Proteinase, serine (Tritirachium album) ecnumber: 686-165-5 | casnumber: 102925-54-2
Proteinase, submandibular gland serine, A ecnumber: 279-893-6 | casnumber: 82047-85-6
Proteinase, Aspergillus parasiticus neutral ecnumber: 254-418-5 | casnumber: 39335-09-6
Proteinase, Bacillus subtilis, sutilain ecnumber: 235-390-3 | casnumber: 12211-28-8
Proteinase, pancreatic ecnumber: 232-626-7 | casnumber: 9001-72-3
Proteinase, Aspergillus acid ecnumber: 232-796-2 | casnumber: 9025-49-4
Proteinase, Agkistrodon serine ecnumber: 232-933-6 | casnumber: 9046-56-4
Myxobacteralphalyticproteinase ecnumber: - | casnumber: 12585-31-8
Proteinase, Bacillus neutral ecnumber: 278-547-1 | casnumber: 76774-43-1
Proteinase, microbial neutral ecnumber: 232-966-6 | casnumber: 9068-59-1
Proteinase, serine ecnumber: 253-431-3 | casnumber: 37259-58-8
Proteinase, Bacillus subtilis ecnumber: 257-520-8 | casnumber: 51931-23-8
Bacillus megaterium protease fermentation product ecnumber: - | casnumber: 68909-17-1
Proteinase, Staphylococcus aureus serine ecnumber: 259-611-8 | casnumber: 55354-32-0
Amylase, mixture with proteinase ecnumber: 685-079-5 | casnumber: 9001-11-0
Proteinase, Bacillus polymyxa neutral ecnumber: 255-914-4 | casnumber: 42613-33-2
Proteinase, Aspergillus oryzae neutral ecnumber: 232-990-7 | casnumber: 9080-55-1
Proteinase, Aspergillus melleus, semialkaline ecnumber: - | casnumber: 76106-83-7
Proteinase, Bacillus licheniformis serine ecnumber: 279-361-3 | casnumber: 79986-26-8
Proteinase, Bacillus subtilis serine ecnumber: 266-557-9 | casnumber: 67051-83-6
Amylase, mixed with proteinase, Bacillus cereus-fermented ecnumber: - | casnumber: 68909-35-3
Proteinase, Aspergillus neutral ecnumber: 278-588-5 | casnumber: 77000-13-6
Proteinase, Mucor aspartic ecnumber: 232-975-5 | casnumber: 9073-79-4
Proteinase, Aspergillus alkaline ecnumber: 232-977-6 | casnumber: 9074-07-1
Proteinase, microbial alkaline ecnumber: 256-863-0 | casnumber: 50936-53-3
Proteinase, Bacillus alkaline ecnumber: 232-972-9 | casnumber: 9073-77-2
Proteinase, microbial acid ecnumber: 256-862-5 | casnumber: 50936-52-2
Proteinase, rhizopus acid ecnumber: 812-486-9 | casnumber: 9074-09-3
Proteinase, Bothrops atrox serine ecnumber: 232-918-4 | casnumber: 9039-61-6
Proteinase, Aspergillus niger neutral ecnumber: 254-422-7 | casnumber: 39346-39-9
Proteinase, Tritirachium album serine ecnumber: 254-457-8 | casnumber: 39450-01-6
Aspergillin M ecnumber: - | casnumber: -
Proteinase, Endothia aspartic ecnumber: 253-395-9 | casnumber: 37205-60-0
Proteinase, Myxobacter AL-1, II ecnumber: 276-716-4 | casnumber: 72561-05-8
Proteinase, bacterial E 30 serine ecnumber: - | casnumber: 39369-34-1
Proteinase, Bacillus subtilis metallo- ecnumber: 232-991-2 | casnumber: 9080-56-2
Proteinase, aspartic ecnumber: 278-856-1 | casnumber: 78169-47-8
Proteinase, Bacillus alcalophilus serine ecnumber: 306-090-0 | casnumber: 95979-76-3
934-013-6
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1

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