EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

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Last updated 26 dubna 2024. Database contains 4821 unique substances/entries.
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Je zobrazeno 1 051 - 1 100 položek z celkového počtu 4 821.
Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
potassium methanolate; potassium methoxide
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
potassium iron(III) 1,3-propanediamine-N, N,N',N'-tetraacetate hemihydrate
FEKPDTA; KFEPDTA
405-680-6
148434-01-9
Self-heat. 2
Potassium hydroxyoctaoxodizincatedichromate
234-329-8
11103-86-9
yes
potassium hydroxide; caustic potash
215-181-3
1310-58-3
Acute Tox. 4; Skin Corr. 1A
potassium hydrogensulphate
231-594-1
7646-93-7
Skin Corr. 1B; STOT SE 3
potassium fluoride
232-151-5
7789-23-3
Acute Tox. 3
potassium ferrite
430-010-4
12160-44-0
Skin Corr. 1B; Skin Sens. 1
potassium ethanolate; potassium ethoxide
213-029-0
917-58-8
Self-heat. 1; Skin Corr. 1B
potassium dichromate
231-906-6
7778-50-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
potassium cyanate
209-676-3
590-28-3
Acute Tox. 4
potassium chromate
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
yes
potassium chlorate
223-289-7
3811-04-9
Ox. Sol. 1; Acute Tox. 4
potassium bromate
231-829-8
7758-01-2
Ox. Sol. 1; Carc. 1B; Acute Tox. 3
potassium bis(N-carboxymethyl)-N-methyl-glycinato-(2-)N, O,O, N)-ferrate-(1-)monohydrate
CHEMICAL CHELATING AGENT #2
411-640-9
153352-59-1
Acute Tox. 4
potassium bifluoride; potassium hydrogen difluoride
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
potassium 4-iodo-2-sulfonato-benzoic acid
426-620-5
619297-89-1
Eye Dam. 1
potassium 4-(11-methacrylamidoundecanamido)benzenesulfonate
V67282
406-500-9
174393-75-0
Skin Sens. 1
potassium 3-iodo-6-methylbenzenesulfonate
426-300-5
-
Eye Dam. 1
potassium 3,6-dichloro-o-anisate
233-002-7
10007-85-9
Eye Irrit. 2
potassium 2-hydroxycarbazole-1-carboxylate
AZYLACID-POTASSIUMSALT
401-630-2
96566-70-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
potassium 2-chloro-3-(benzyloxy)propionate
KLOBENPROP
426-350-8
138666-92-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
potassium 2-amino-2-methylpropionate octahydrate
FLEXSORB HP SOLID; MALINE K
405-560-3
120447-91-8
Acute Tox. 4; Skin Corr. 1A
potassium 2-(2,4-dichlorophenoxy)-(R)-propionate
DUPLOSAN-DP-KALIUM
413-580-9
113963-87-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
potassium 2,5-dichlorobenzoate
POTASSIUM 2,5-DICHLOROBENZOATE
415-700-5
184637-62-5
Acute Tox. 4; Eye Dam. 1
Potassium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionate
266-578-3
67118-55-2
yes
potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing < 0,5 % N, N-dimethylformamide (EC no; 200-679-5)];potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing ≥ 0,5 % N, N-dimethylformamide (EC No 200-679-5)]
418-260-2
183196-57-8
Repr. 1B; Skin Sens. 1
potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing < 0,5 % N, N-dimethylformamide (EC no; 200-679-5)];potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing ≥ 0,5 % N, N-dimethylformamide (EC No 200-679-5)]
418-260-2
183196-57-8
Skin Sens. 1
potassium (oxido-NNO-azoxy)cyclohexane; cyclohexylhydroxydiazene 1-oxide, potassium salt; [K-HDO]
613-953-8
66603-10-9
Flam. Sol. 1; Acute Tox. 3; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
potassium (E,E)-hexa-2,4- dienoate
246-376-1
24634-61-5
Eye Irrit. 2
potassium
231-119-8
7440-09-7
Water-react. 1; Skin Corr. 1B
potasan; O, O-diethyl O-(4-methylcoumarin-7-yl) phosphorothioate
-
299-45-6
Acute Tox. 2; Acute Tox. 1
Porphyromonas spp.
-
-
B Bacteria and similar species
polymeric reaction product of bicyclo[2.2.1]hepta-2,5-diene, ethene, 1,4-hexadiene, 1-propene with N, N-di-2-propenylformamide
X4060
404-035-6
1379801-27-0
Skin Sens. 1
polymer of allylamine hydrochloride
PAA HCL; PAA HCL 10L; PAA HCL 10S; PAA HCL 3L; PAA HCL 3S; PAA HCL H; PAA HCL L
415-050-2
71550-12-4
Acute Tox. 4; Skin Sens. 1
polyhexamethylene biguanide hydrochloride; PHMB
608-723-9
32289-58-0
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
polyhexamethylene biguanide hydrochloride; PHMB
608-042-7
27083-27-8
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
Polyethylene glycol mono(tert-octylph-enyl) ether9036-19-5
618-541-1
9036-19-5
yes
polychlorobiphenyls; PCB
215-648-1
1336-36-3
STOT RE 2
poly-[((4-((4-ethyl-ethylene)amino)phenyl)-((4-(ethyl-(2-oxyethylene)amino)phenyl)methinyl)cyclohexa-2,5-dienylidene)-N-ethyl-N-(2-hydroxyethyl)ammonium acetate]
427-280-0
176429-27-9
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
poly-[((4-((4-(ethyl-ethylene)amino)phenyl)-(4-(ethyl-(2-oxyethylene)amino)phenyl)methinyl)-3-methylcyclohexa-2,5-dienylidene)-N-ethyl-N-(2-hydroxyethyl)ammonium acetate]
427-480-8
176429-22-4
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
poly-(methyl methacrylate)-co-(butylmethacrylate)-co-(4-acryloxybutyl-isopropenyl-α, α-dimethylbenzyl carbamate)-co-(maleicanhydride)
RX-33
419-590-1
-
Flam. Sol. 1; Skin Sens. 1
poly(oxypropylenecarbonyl-co-oxy(ethylethylene)carbonyl), containing 27 % hydroxyvalerate
BIOPOL HX
403-300-3
127536-43-0
Skin Sens. 1
poly(oxo(2-butoxyethyl-3-oxobutanoato-O'1,O'3)aluminium)
AOC 2050X
403-430-0
138360-92-6
Eye Dam. 1
Polioviruses
-
-
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.
Plesiomonas shigelloides
-
-
B Bacteria and similar species
platinum(IV) nitrate/nitric acid solution
432-400-1
10102-09-7
Skin Corr. 1A
Plasmodium spp. (human and simian)
-
-
P Parasites
Plasmodium falciparum
-
-
P Parasites
Pitch; Pitch
263-072-4
61789-60-4
Carc. 1B
Pitch, coal tar-petroleum; Pitch Residues [The residue from the distillation of a mixture of coal tar and aromatic petroleum streams. A solid with a softening point from 40°C to 180°C (140°F to 356°F). Composed; primarily of a complex combination of three or more membered condensed ring aromatic hydrocarbons.]
The residue from the distillation of a mixture of coal tar and aromatic petroleum streams. A solid with a softening point from 40°C to 180°C (104°F to 356°F). Composed primarily of a complex combination of three or more membered condensed ring aromatic hydrocarbons.
269-109-0
68187-57-5
Carc. 1B
Stránka 22   97
50 Položek na stránku
Je zobrazeno 1 051 - 1 100 položek z celkového počtu 4 821.

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