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 srpnja 2024. Database contains 4917 unique substances/entries.
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608-192-3
283159-90-0
Carc. 2
Details
FAT 40'489
413-040-2
149850-30-6
Skin Sens. 1
Details
414-460-9
105726-67-8
Acute Tox. 4
Details
209-060-4
554-12-1
Flam. Liq. 2; Acute Tox. 4
Details
204-317-7
119-36-8
Repr. 2; Acute Tox. 4; Skin Sens. 1B
Details
METHFAT
420-670-1
37443-42-8
Eye Dam. 1
Details
203-475-4
107-25-5
Flam. Gas 1; Press. Gas
Details
F5384
401-340-6
83055-99-6
Skin Sens. 1
Details
236-035-5
13108-52-6
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
N 5297
419-010-5
112941-26-1
Acute Tox. 4; Eye Irrit. 2
Details
BETA-METHOXYACRYLSÄURE METHYLESTER
412-900-4
5788-17-0
Skin Sens. 1
Details
435-500-1
152460-07-6
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
209-765-7
592-62-1
Carc. 1B; Repr. 1B
Details
246-910-3
25376-45-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
Details
203-624-3
108-87-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
Details
228-652-3
6317-18-6
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
Details
247-714-0
26447-40-5
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
429-320-2
24748-23-0
Org. Perox. B; Asp. Tox. 1; Skin Irrit. 2; Skin Sens. 1
Details
200-471-4
60-34-4
Carc. 1B
Details
204-064-2
115-09-3
Carc. 2; Repr. 1A; Lact.; Acute Tox. 2; STOT RE 1
Details
METHYL-TPP-CHLORID; MTPP-CHLORID
418-400-2
1031-15-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
214-446-0
1129-41-5
Acute Tox. 4
Details
410-240-1
139528-85-1
Carc. 2; STOT RE 2
Details
244-209-7
21087-64-9
Acute Tox. 4; STOT RE 2
Details
232-095-1
7786-34-7
Acute Tox. 1; Acute Tox. 2
Details
206-249-3
315-18-4
Acute Tox. 2; Acute Tox. 4
Details
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F Fungi
Details
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Acute Tox. 4
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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1314-04-1
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
Details
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Glass, oxide, chemicals
This category encompasses the various chemical substances manufactured in the production of inorganic glasses. For purposes of this category, 'glass' is defined as an amorfous, inorganic, transparent, translucent or opaque material traditionally formed by fusion of sources of silica with a flux, such as an alkali-metal carbonate, boron oxide, etc. and a stabilizer, into a mass which is cooled to a rigid condition without crystallization in the case of transparent or liquid-phase separated glass or with controlled crystallization in the case of glass-ceramics. The category consists of the various chemical substances, other than by-products or impurities, which are formed during the production of various glasses and concurrently incorporated into a glass mixture. All glasses contain one or more of these substances, but few, if any, contain all of them. The elements listed below are principally present as components of oxide systems but some may also be present as halides or chalcogenides, in multiple oxidation states, or in more complex compounds. Trace amounts of other oxides or chemical compounds may be present. Oxides of the first seven elements listed* comprise more than 95 percent, by weight, of the glass produced. @Aluminium*@Lead@Boron*@Lithium@Calcium*@Manganese@Magnesium*@Molybdenum@Potassium*@Neodymium@Silicon*@Nickel@Sodium*@Niobium@Antimony@Nitrogen@Arsenic@Phosphorus@Barium@Praseodymium@Bismuth@Rubidium@Cadmium@Selenium@Carbon@Silver@Cerium@Strontium@Cesium@Sulfur@Chromium@Tellurium@Cobalt@Tin@Copper@Titanium@Germanium@Tungsten@Gold@Uranium@Holmium@Vanadium@Iron@Zinc@Lanthanum@Zirconium
EC / List no: 266-046-0 | CAS no: 65997-17-3
Glass Wool EC / List no: - | CAS no: 308066-92-4
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Carc. 2
Details
206-742-3
371-86-8
STOT SE 1
Details
215-293-2
1319-77-3
Acute Tox. 3; Skin Corr. 1B
Details
NUPORE G45-10
420-480-9
158570-99-1
Skin Irrit. 2; Skin Sens. 1
Details
218-661-0
2212-67-1
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
Details
268-585-7
68130-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
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12673-58-4
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
238-034-5
14177-55-0
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
215-204-7
1313-27-5
Carc. 2; Eye Irrit. 2; STOT SE 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
ICI204636 HYDROGEN FUMARATE
415-180-1
773058-82-5
Acute Tox. 4; Eye Dam. 1
Details
200-820-0
74-89-5
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
200-820-0
74-89-5
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
Details
Z-22
415-880-5
779343-34-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
203-083-3
103-16-2
Eye Irrit. 2; Skin Sens. 1
Details
230-042-7
6923-22-4
Muta. 2; Acute Tox. 2; Acute Tox. 3
Details
217-129-5
1746-81-2
Acute Tox. 4; STOT RE 2
Details
429-570-2
213990-58-0
Skin Sens. 1
Details
205-766-1
150-68-5
Carc. 2; Acute Tox. 4
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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7411-47-4
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
225-062-8
4636-83-3
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
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29873-36-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
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B Bacteria and similar species
Details
203-815-1
110-91-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
Details
239-213-0
15159-40-7
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
Details
205-628-0
144-41-2
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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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
248-505-7
27519-02-4
Skin Sens. 1B
Details
201-328-9
81-14-1
Carc. 2
Details
SYSTHANE TECHNICAL
410-400-0
88671-89-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
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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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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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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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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B Bacteria and similar species
Details
435-860-1
214417-91-1
Skin Sens. 1
Details
429-380-1
133336-92-2
Skin Sens. 1
Details
430-930-6
122886-55-9
Eye Dam. 1; Resp. Sens. 1
Details
435-010-8
26157-73-3
Muta. 2
Details
LUPRAGEN VP 9159
401-660-6
1000-78-8
Skin Irrit. 2; Skin Sens. 1
Details
BMS 208143-01; BTHC
429-670-6
105996-54-1
Eye Dam. 1; Skin Sens. 1
Details
200-806-4
74-31-7
Skin Sens. 1
Details
H-603
404-790-1
66710-66-5
Eye Dam. 1; Skin Sens. 1
Details
CARTASOL BRILLIANT YELLOW K-6G; CARTASOL BRILLIANT YELLOW K-6G CONC.; GIALLO BRILLANTE CARTASOL K-6G CONC.; JAUNE BRILLANT CARTASOL K-RWA 3904; RWA 3904
403-340-1
164578-09-0
Eye Dam. 1
Details
202-831-6
100-22-1
Acute Tox. 4
Details
AF-172; FPC 114
405-300-9
17339-60-5
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
203-744-6
110-18-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
Details
435-470-1
27366-72-9
Repr. 1B
Details
DIETHANOLAMIN-TRITOSYLAT
412-920-3
16695-22-0
Skin Sens. 1
Details
CM 23-376; REOMET 30
401-280-0
91273-04-0
Skin Corr. 1B; Skin Sens. 1
Details
203-336-8
105-83-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
Details

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