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 svibnja 2024. Database contains 4917 unique substances/entries.
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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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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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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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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
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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C Carcinogenic (article 57a)
M Mutagen (article 57b)
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Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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Acute Tox. 3
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Acute Tox. 3
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Binapacryl EC / List no: 207-612-9 | CAS no: 485-31-4
Dinoseb acetate EC / List no: 220-560-1 | CAS no: 2813-95-8
Sodium 2-(1-methylpropyl)-4,6-dinitrophenolate EC / List no: 252-331-7 | CAS no: 35040-03-0
Ammonium 2-sec-butyl-4,6-dinitrophenolate EC / List no: 228-858-3 | CAS no: 6365-83-9
2-sec-butyl-4,6-dinitrophenol, compound with 1-aminopropan-2-ol (1:1) EC / List no: 275-931-0 | CAS no: 71735-19-8
2-sec-butyl-4,6-dinitrophenol, compound with 2,2'-iminodiethanol (1:1) EC / List no: 258-532-6 | CAS no: 53404-43-6
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Repr. 1B; Acute Tox. 3; Eye Irrit. 2
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2-tert-butyl-4,6-dinitrophenyl acetate EC / List no: 221-706-7 | CAS no: 3204-27-1
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Repr. 1B; Acute Tox. 2; Acute Tox. 3
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Acute Tox. 4
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Acute Tox. 4
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Carc. 1B; Acute Tox. 4
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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)
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(2,4-Dichlorophenoxy)acetic acid triethylamine salt EC / List no: - | CAS no: 2646-78-8
Trimethylammonium 2,4-dichlorophenoxyacetate EC / List no: 229-132-9 | CAS no: 6416-73-5
Zinc bis[(2,4-dichlorophenoxy)acetate] EC / List no: 250-495-4 | CAS no: 31166-17-3
Potassium (2,4-dichlorophenoxy)acetate EC / List no: 238-070-1 | CAS no: 14214-89-2
Sodium 2,4-dichlorophenoxyacetate EC / List no: 220-290-4 | CAS no: 2702-72-9
Dimethylammonium 2,4-dichlorophenoxyacetate EC / List no: 217-915-8 | CAS no: 2008-39-1
Bis(2-hydroxyethyl)ammonium 2,4-dichlorophenoxyacetate EC / List no: 227-256-8 | CAS no: 5742-19-8
(2-hydroxyethyl)ammonium (o,p-dichlorophenoxy)acetate EC / List no: 222-752-0 | CAS no: 3599-58-4
Diethylammonium (o,p-dichlorophenoxy)acetate EC / List no: 244-120-3 | CAS no: 20940-37-8
(2,4-Dichlorophenoxy)acetic acid isopropylamine salt EC / List no: 690-142-5 | CAS no: 5742-17-6
Tris(2-hydroxyethyl)ammonium (o,p-dichlorophenoxy)acetate EC / List no: 219-911-1 | CAS no: 2569-01-9
Dodecylammonium (o,p-dichlorophenoxy)acetate EC / List no: 218-660-5 | CAS no: 2212-54-6
Ammonium 2,4-dichlorophenoxyacetate EC / List no: 218-986-8 | CAS no: 2307-55-3
Aluminium tris(2,4-dichlorophenoxyacetate) EC / List no: 250-497-5 | CAS no: 31166-18-4
2,4-D-lithium EC / List no: 693-035-1 | CAS no: 3766-27-6
Tetradecylammonium (o,p-dichlorophenoxy)acetate EC / List no: 249-156-3 | CAS no: 28685-18-9
Acetic acid, (2,4-dichlorophenoxy)-, copper(2) salt EC / List no: - | CAS no: 63034-89-9
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
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Acute Tox. 4; Eye Dam. 1
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2-naphthylammonium chloride EC / List no: 210-313-6 | CAS no: 612-52-2
2-naphthylammonium acetate EC / List no: 209-030-0 | CAS no: 553-00-4
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Carc. 1A; Acute Tox. 4
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Carc. 1B; Acute Tox. 4; Skin Sens. 1
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Carc. 1B; Acute Tox. 4
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Carc. 1B; Acute Tox. 4
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