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 24 lipnja 2024. Database contains 4917 unique substances/entries.
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P Parasites
Details
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P Parasites
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57427-55-1
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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R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
291-844-0
90481-04-2
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
270-966-8
68512-30-1
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
276-743-1
72624-02-3
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
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Phenol, 4-isododecyl- EC / List no: 608-055-8 | CAS no: 27147-75-7
Phenol, dodecyl-, branched EC / List no: 310-154-3 | CAS no: 121158-58-5
Phenol, tetrapropylene- EC / List no: - | CAS no: 57427-55-1
[No public or meaningful name is available] EC / List no: - | CAS no: 27459-10-5
Phenol, (tetrapropenyl) derivatives EC / List no: 616-100-8 | CAS no: 74499-35-7
Phenol, 4-dodecyl, branched EC / List no: 640-104-9 | CAS no: 210555-94-5
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)
Details
310-154-3
121158-58-5
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
310-154-3
121158-58-5
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
608-492-4
3050-88-2
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
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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
201-581-5
85-01-8
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
206-587-1
355-46-4
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
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potassium perfluoroheptanoate EC / List no: - | CAS no: 21049-36-5
Ammonium perfluoroheptanoate EC / List no: 228-098-2 | CAS no: 6130-43-4
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
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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)
Details
206-793-1
375-73-5
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)
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
R Toxic for reproduction (article 57c)
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
R Toxic for reproduction (article 57c)
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
R Toxic for reproduction (article 57c)
Details
600-419-4
10332-33-9
R Toxic for reproduction (article 57c)
Details
600-611-8
10486-00-7
R Toxic for reproduction (article 57c)
Details
603-902-8
13517-20-9
R Toxic for reproduction (article 57c)
Details
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B Bacteria and similar species
Details
256-418-0
49663-84-5
C Carcinogenic (article 57a)
Details
235-067-7
12065-90-6
R Toxic for reproduction (article 57c)
Details
276-745-2
72629-94-8
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
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F Fungi
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B Bacteria and similar species
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B Bacteria and similar species
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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P Parasites
Details
307-202-0
97553-43-0
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
287-196-3
85422-92-0
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
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F Fungi
Details
203-199-4
104-40-5
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
247-770-6
26543-97-5
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
241-427-4
17404-66-9
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
201-280-9
80-46-6
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
250-339-5
30784-30-6
ENDE Endocrine disrupting properties (Article 57(f) - environment)
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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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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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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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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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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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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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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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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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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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
215-235-6
1314-41-6
R Toxic for reproduction (article 57c)
Details

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