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).

EU REACH: List of SVHC
R Toxic for reproduction (article 57c)

ENDE Endocrine disrupting properties (Article 57(f) - environment)

END Endocrine disrupting properties (Article 57(f) - human health)


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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
Phenol, 4-isododecyl- 608-055-8 27147-75-7 Official source
Phenol, dodecyl-, branched 310-154-3 121158-58-5 Official source
Phenol, 4-dodecyl, branched 640-104-9 210555-94-5 Official source
[No public or meaningful name is available] - 27459-10-5 Official source
Phenol, (tetrapropenyl) derivatives 616-100-8 74499-35-7 Official source
Phenol, tetrapropylene- - 57427-55-1 Official source