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 20 svibnja 2024. Database contains 4917 unique substances/entries.
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418-270-7
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Skin Sens. 1
Details
414-910-4
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Eye Dam. 1; Skin Sens. 1
Details
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B Bacteria and similar species
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potassium perfluoroheptanoate EC / List no: - | CAS no: 21049-36-5
Sodium perfluoroheptanoate EC / List no: 243-518-4 | CAS no: 20109-59-5
Perfluoroheptanoic acid EC / List no: 206-798-9 | CAS no: 375-85-9
Ammonium perfluoroheptanoate EC / List no: 228-098-2 | CAS no: 6130-43-4
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R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
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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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Phenol, 4-dodecyl, branched EC / List no: 640-104-9 | CAS no: 210555-94-5
Phenol, (tetrapropenyl) derivatives EC / List no: 616-100-8 | CAS no: 74499-35-7
[No public or meaningful name is available] EC / List no: - | CAS no: 27459-10-5
Phenol, tetrapropylene- EC / List no: - | CAS no: 57427-55-1
Phenol, dodecyl-, branched EC / List no: 310-154-3 | CAS no: 121158-58-5
Phenol, 4-isododecyl- EC / List no: 608-055-8 | CAS no: 27147-75-7
799-972-3
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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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R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
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P Parasites
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P Parasites
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B Bacteria and similar species
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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RX-33
419-590-1
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Flam. Sol. 1; Skin Sens. 1
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B Bacteria and similar species
Details
426-300-5
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Eye Dam. 1
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C Carcinogenic (article 57a)
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REAKTIVROT 2713
412-490-7
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Skin Sens. 1
Details
C.I. REACTIVE RED 231
402-150-6
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Eye Irrit. 2; Skin Sens. 1
Details
425-830-4
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Eye Dam. 1
Details
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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B Bacteria and similar species
Details
BROWN JR 547
419-260-5
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Eye Dam. 1
Details
425-740-5
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Eye Dam. 1
Details
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Details
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B Bacteria and similar species
Details
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B Bacteria and similar species
Details

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