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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231-842-9
7758-89-6
Acute Tox. 4
Details
ALLYL SUCROSE
419-640-0
68784-14-5
Acute Tox. 4
Details
INDULIN MQK-1M
413-770-1
-
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
SUBSTANCE S171393
427-390-9
-
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
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
Details
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
Details
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F Fungi
Details
215-273-3
1317-42-6
Skin Sens. 1
Details
233-334-2
10124-43-3
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
215-154-6
1307-96-6
Acute Tox. 4; Skin Sens. 1
Details
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77332.
269-051-6
68186-89-0
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
261-346-8
58591-45-0
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
442-750-5
113066-89-0
Carc. 1A; Acute Tox. 2; STOT RE 1; Skin Sens. 1
Details
233-402-1
10141-05-6
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
200-755-8
71-48-7
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
208-169-4
513-79-1
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
231-158-0
7440-48-4
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
Details
The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydrogenated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.
302-682-8
94114-47-3
Carc. 1B
Details
The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.
302-683-3
94114-48-4
Carc. 1B
Details
433-460-1
210880-92-5
Repr. 2; Acute Tox. 4; STOT SE 1
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
204-385-8
120-32-1
Carc. 2; Repr. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1; Eye Dam. 1; STOT RE 2
Details
216-935-4
1702-17-6
Eye Dam. 1
Details
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P Parasites
Details
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P Parasites
Details
617-258-0
81777-89-1
Acute Tox. 4
Details
600-662-6
105512-06-9
Acute Tox. 4; STOT RE 2; Skin Sens. 1
Details
619-396-7
99129-21-2
Acute Tox. 4; Skin Sens. 1
Details
A complex combination of hydrocarbons obtained by treating catalytic cracked clarified oil with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
269-782-0
68333-26-6
Carc. 1B
Details
A complex combination of hydrocarbons produced as the residual fraction from distillation of the products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-064-6
64741-62-4
Carc. 1B
Details
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F Fungi
Details
245-119-0
22605-92-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
242-161-1
18283-82-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
201-069-1
77-92-9
Eye Irrit. 2; STOT SE 3
Details
226-394-6
5392-40-5
Skin Irrit. 2; Skin Sens. 1
Details
205-859-7
156-59-2
Flam. Liq. 2; Acute Tox. 4
Details
236-086-3
13149-00-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
231-187-9
7443-70-1
Acute Tox. 4
Details
422-660-2
7480-35-5
Eye Dam. 1; Skin Sens. 1
Details
PD 133602-2
417-430-3
63645-17-0
Acute Tox. 3; STOT RE 2; Skin Sens. 1
Details
426-020-3
51229-78-8
Flam. Sol. 2; Repr. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
Details
425-080-8
104860-26-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
Details
213-308-7
935-79-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
Details

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