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 11 listopada 2024. Database contains 4918 unique substances/entries.
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204-661-8
123-91-1
Flam. Liq. 2; Carc. 1B; Eye Irrit. 2; STOT SE 3
C Carcinogenic (article 57a)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
Details
221-641-4
3173-72-6
STOT SE 3; Skin Irrit. 2; Eye Irrit. 2; Resp. Sens. 1; Skin Sens. 1A
Details
221-641-4
3173-72-6
Acute Tox. 2; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2; Resp. Sens. 1; Skin Sens. 1A
Details
218-817-8
2243-62-1
Carc. 2
Details
236-948-9
13560-89-9
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
239-139-9
15087-24-8
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
204-081-5
115-31-1
Acute Tox. 4
Details
246-011-6
24083-03-2
Acute Tox. 4
Details
201-162-7
78-96-6
Skin Corr. 1B
Details
203-445-0
106-94-5
Flam. Liq. 2; Repr. 1B; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
R Toxic for reproduction (article 57c)
Details

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