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 19 travnja 2024. Database contains 4917 unique substances/entries.
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Acute Tox. 3
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Acute Tox. 3
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Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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425-210-3
169939-84-8
Skin Sens. 1
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C Carcinogenic (article 57a)
M Mutagen (article 57b)
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68583-35-7
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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B Bacteria and similar species
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200-712-3
69-72-7
Repr. 2; Acute Tox. 4; Eye Dam. 1
Details
202-345-4
94-59-7
Carc. 1B; Muta. 2; Acute Tox. 4
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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
617-100-0
8051-02-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
618-004-1
87392-12-9
Skin Sens. 1
Details
243-193-9
19622-19-6
Acute Tox. 4
Details
249-013-5
28434-00-6
Acute Tox. 4
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2635-50-9
Acute Tox. 3
Details
620-370-2
2703-37-9
Acute Tox. 2; Acute Tox. 1
Details
X4261
401-850-9
255881-94-8
PBT Persistent, Bioaccumulative and Toxic (article 57d)
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953-17-3
Acute Tox. 3
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ALKYL ISOCYANATE SILANE SCD 617
402-290-8
85702-90-5
Flam. Liq. 3; Resp. Sens. 1; Skin Sens. 1
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436-690-9
220727-26-4
Skin Sens. 1
Details
R-GLYCIDOL
404-660-4
57044-25-4
Self-react. C; Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
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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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Skin Sens. 1
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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
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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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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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B Bacteria and similar species
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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B Bacteria and similar species
Details
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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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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
203-585-2
108-46-3
Acute Tox. 4; STOT SE 1; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1B
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233-940-7
10453-86-8
Acute Tox. 4
Details
277-299-1
73138-82-6
Skin Sens. 1
Details
A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and vacuum gas oil. It predominantly consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C (446°F).
270-796-4
68478-17-1
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment and distillation of raw steam-cracked naphtha. It consists predominantly of unsaturated hydrocarbons boiling in the range above approximately 180°C (356°F).
308-733-0
98219-64-8
Carc. 1B
Details

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