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 lipnja 2024. Database contains 4917 unique substances/entries.
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215-273-3
1317-42-6
Skin Sens. 1
Details
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F Fungi
Details
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
Details
200-673-2
67-97-0
Acute Tox. 2; STOT RE 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
SUBSTANCE S171393
427-390-9
-
Skin Sens. 1
Details
INDULIN MQK-1M
413-770-1
-
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
ALLYL SUCROSE
419-640-0
68784-14-5
Acute Tox. 4
Details
231-842-9
7758-89-6
Acute Tox. 4
Details
243-815-9
20427-59-2
Acute Tox. 2; Acute Tox. 4; Eye Dam. 1
Details
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Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
Details
231-847-6
7758-98-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Details
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
Details
235-113-6
12069-69-1
Acute Tox. 4; Eye Irrit. 2
Details
KUPFER-II-METHANSULFONAT; KUPFERMETHANSULFONAT
405-400-2
54253-62-2
Acute Tox. 4; Eye Dam. 1
Details
204-810-7
126-90-9
Skin Sens. 1B
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
Details
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68583-16-4
B Bacteria and similar species
Details
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B Bacteria and similar species
Details
201-378-1
81-82-3
STOT RE 2
Details
204-195-5
117-52-2
Acute Tox. 3; STOT RE 1
Details
200-285-3
56-72-4
Acute Tox. 2; Acute Tox. 4
Details
227-424-0
5836-29-3
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
Details
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572-48-5
Acute Tox. 3
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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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
The distillate of coal tar produced by the high temperature carbonization of bituminous coal. It consists primarily of aromatic hydrocarbons, tar acids and tar bases.
232-287-5
8001-58-9
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic hydrocarbons and may contain appreciable quantities of tar acids and tar bases. It distills at the approximate range of 200°C to 325°C (392°F to 617°F).
263-047-8
61789-28-4
Carc. 1B
Details
The oil remaining after removal by a crystallization process of acenaphthene from acenaphthene oil from coal tar. Composed primarily of naphthalene and alkylnaphthalenes.
292-606-9
90640-85-0
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillation of coal tar and boiling in the range of approximately 240°C to 280°C (464°F to 536°F). Composed primarily of acenaphthene, naphthalene and alkyl naphthalene.
292-605-3
90640-84-9
Carc. 1B
Details
The high-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillates, removed. It is crystal free at approximately 5°C (41°F).
274-565-9
70321-79-8
Carc. 1B
Details
The low-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal, which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillate, removed. It is crystal free at approximately 38°C (100°F).
274-566-4
70321-80-1
Carc. 1B
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
208-622-6
535-89-7
Acute Tox. 2
Details
224-030-0
4170-30-3
Flam. Liq. 2; Muta. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
231-720-5
7700-17-6
Acute Tox. 3
Details
206-083-1
299-86-5
Acute Tox. 4
Details
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F Fungi
Details
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F Fungi
Details
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P Parasites
Details
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P Parasites
Details
202-704-5
98-82-8
Flam. Liq. 3; Carc. 1B; Asp. Tox. 1; STOT SE 3
Details
206-992-3
420-04-2
Carc. 2; Repr. 2; Acute Tox. 3; STOT RE 2; Skin Corr. 1; Skin Sens. 1; Eye Dam. 1
Details
244-544-9
21725-46-2
Acute Tox. 4
Details
620-377-0
13067-93-1
Acute Tox. 3; STOT SE 1; Acute Tox. 4; Eye Irrit. 2
Details
220-130-3
2636-26-2
Acute Tox. 4
Details

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