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)
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin 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
Hexachloroplatinate(2-) - 16871-54-8 Expert judgement
Dipotassium hexachloroplatinate 240-979-3 16921-30-5 Expert judgement
Bis(benzyltrimethylammonium) hexachloroplatinate(2-) 255-585-7 41909-89-1 Expert judgement
Hexachloroplatinic acid 241-010-7 16941-12-1 Expert judgement
Dicesium hexachloroplatinate 240-945-8 16902-25-3 Expert judgement
Chloroplatinic acid hexahydrate 629-612-1 18497-13-7 Expert judgement
Dihydrogen hexachloroplatinate, compound with 1,1,3,3-tetramethyl-1,3-divinyldisiloxane 258-092-5 52672-74-9 Expert judgement
Diammonium hexachloroplatinate 240-973-0 16919-58-7 Expert judgement
Disodium hexachloroplatinate 240-983-5 16923-58-3 Expert judgement
Platinate(2-), hexachloro-, (OC-6-11)-, dihydrogen, reaction products with tributylphosphine hydrochloride and N-(3-(trimethoxysilyl)propyl)-1,2-ethanediamine - 67924-25-8 Expert judgement
Platinate(2-), hexachloro-, dihydrogen, (OC-6-11)-, reaction products with palladium - 68516-04-1 Expert judgement
Natriumchloroplatinat 626-326-9 19583-77-8 Expert judgement
Platinate(2-), hexachloro-, (OC-6-11)-, dihydrogen, reaction products with 2,4,6,8-tetraethenyl-2,4,6,8-tetramethylcyclotetrasiloxane 271-555-6 68585-32-0 Expert judgement