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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 17 svibnja 2024. Database contains 4821 unique substances/entries.
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METHYL-TPP-CHLORID; MTPP-CHLORID
418-400-2
1031-15-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
214-446-0
1129-41-5
Acute Tox. 4
410-240-1
139528-85-1
Carc. 2; STOT RE 2
244-209-7
21087-64-9
Acute Tox. 4
232-095-1
7786-34-7
Acute Tox. 1; Acute Tox. 2
206-249-3
315-18-4
Acute Tox. 2; Acute Tox. 4
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F Fungi
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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.
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1314-04-1
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
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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
206-742-3
371-86-8
STOT SE 1
215-293-2
1319-77-3
Acute Tox. 3; Skin Corr. 1B
NUPORE G45-10
420-480-9
158570-99-1
Skin Irrit. 2; Skin Sens. 1
218-661-0
2212-67-1
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
268-585-7
68130-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
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12673-58-4
Carc. 1A; STOT RE 1; Skin Sens. 1
238-034-5
14177-55-0
Carc. 1A; STOT RE 1; Skin Sens. 1
215-204-7
1313-27-5
Carc. 2; Eye Irrit. 2; STOT SE 3
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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.
ICI204636 HYDROGEN FUMARATE
415-180-1
773058-82-5
Acute Tox. 4; Eye Dam. 1
200-820-0
74-89-5
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-820-0
74-89-5
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
Z-22
415-880-5
779343-34-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-083-3
103-16-2
Eye Irrit. 2; Skin Sens. 1
230-042-7
6923-22-4
Muta. 2; Acute Tox. 2; Acute Tox. 3
217-129-5
1746-81-2
Acute Tox. 4; STOT RE 2
429-570-2
213990-58-0
Skin Sens. 1
205-766-1
150-68-5
Carc. 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.
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7411-47-4
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
225-062-8
4636-83-3
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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29873-36-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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B Bacteria and similar species
203-815-1
110-91-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
239-213-0
15159-40-7
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
205-628-0
144-41-2
Acute Tox. 3
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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.
248-505-7
27519-02-4
Skin Sens. 1B
201-328-9
81-14-1
Carc. 2
201-329-4
81-15-2
Expl. 1.1; Carc. 2
yes
SYSTHANE TECHNICAL
410-400-0
88671-89-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
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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
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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
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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
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B Bacteria and similar species
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B Bacteria and similar species
435-860-1
214417-91-1
Skin Sens. 1
429-380-1
133336-92-2
Skin Sens. 1
445-760-8
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Eye Dam. 1; Resp. Sens. 1
435-010-8
26157-73-3
Muta. 2
LUPRAGEN VP 9159
401-660-6
1000-78-8
Skin Irrit. 2; Skin Sens. 1
BMS 208143-01; BTHC
429-670-6
105996-54-1
Eye Dam. 1; Skin Sens. 1
200-806-4
74-31-7
Skin Sens. 1
H-603
404-790-1
66710-66-5
Eye Dam. 1; Skin Sens. 1
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
202-831-6
100-22-1
Acute Tox. 4
AF-172; FPC 114
405-300-9
17339-60-5
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
203-744-6
110-18-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
435-470-1
27366-72-9
Repr. 1B
DIETHANOLAMIN-TRITOSYLAT
412-920-3
16695-22-0
Skin Sens. 1
CM 23-376; REOMET 30
401-280-0
91273-04-0
Skin Corr. 1B; Skin Sens. 1
203-336-8
105-83-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
445-890-5
201290-01-9
Acute Tox. 4; Skin Sens. 1
418-290-6
168612-06-4
Eye Irrit. 2; Skin Sens. 1
DDPD
406-610-7
62478-82-4
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1A
HOSTALUX VP 3481
401-410-6
10357-99-0
STOT RE 2; Skin Sens. 1
B1; N,N-DIMETHYLANILINUM TETRAKIS(PENTAFLUOROPHENYL)BORATE; TÉTRAKIS(PENTAFLUOROPHÉNYL)BORATE DE N,N-DIMÉTHYLANILINIUM
422-050-6
118612-00-3
Carc. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
200-679-5
68-12-2
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
yes
F.H.D.A.
403-510-5
19247-05-3
Acute Tox. 3; STOT RE 2; Skin Sens. 1
NYLOSTAB S-EED; NYSEED
419-710-0
42774-15-2
Acute Tox. 4; Eye Irrit. 2
RED REN 363
419-500-9
171599-85-2
Eye Dam. 1; Skin Sens. 1
210-338-2
613-35-4
Carc. 1B; Muta. 2; Acute Tox. 4
QUESTAMIDE H
422-560-9
149591-38-8
Repr. 2; Eye Irrit. 2
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2810-74-4
Acute Tox. 4
227-062-3
5625-90-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1; Eye Dam. 1
LICHTSCHUTZMITTEL 1736
413-610-0
124172-53-8
Eye Irrit. 2
PFMT 1848
410-060-3
130728-76-6
Muta. 2; Skin Sens. 1
202-959-2
101-61-1
Carc. 1B
yes
CHIMASSORB 119; LOWILITE 19
401-990-0
106990-43-6
Skin Sens. 1
205-319-0
138-24-9
Acute Tox. 3
431-530-4
1380226-29-8
Skin Corr. 1A; Skin Sens. 1

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