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).

Last updated 14 listopada 2024. Database contains 4918 unique substances/entries.
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A colorless, refined petroleum distillate that is free from rancid or objectionable odors and that boils in a range of approximately 148.8°C to 204.4°C (300°F to 400°F).
232-489-3
8052-41-3
Carc. 1B; Muta. 1B; STOT RE 1; Asp. Tox. 1
Details
A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.
232-484-6
8052-10-6
Skin Sens. 1
Details
617-100-0
8051-02-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
A complex combination derived from wood, especially pine wood. Composed primarily of resin acids and modified resin acids such as dimers and decarboxylated resin acids. Includes rosin stabilized by catalytic disproportionation.
232-475-7
8050-09-7
Skin Sens. 1
Details
SP 807
420-150-4
80498-15-3
Resp. Sens. 1
Details
279-452-8
80387-97-9
Repr. 1B; Skin Sens. 1
Details
A complex combination of hydrocarbons obtained by the fractional distillation of petroleum. This fraction boils in a range of approximately 20°C to 135°C (58°F to 275°F).
232-453-7
8032-32-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
Refined, partly refined, or unrefined petroleum products produced by the distillation of natural gas. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C6 and boiling in the range of approximately 100°C to 200°C (212°F to 392°F).
232-443-2
8030-30-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
616-995-5
8018-01-7
Carc. 2; Repr. 1B; STOT RE 2; Skin Sens. 1
Details
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
R Toxic for reproduction (article 57c)
Details

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