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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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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.
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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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Zinc dichromate EC / List no: 237-843-0 | CAS no: 14018-95-2
Chromic acid, potassium zinc salt EC / List no: 255-252-6 | CAS no: 41189-36-0
C.I. Pigment Yellow 36 EC / List no: 609-398-6 | CAS no: 37300-23-5
Zinc chromate EC / List no: 236-878-9 | CAS no: 13530-65-9
Pentazinc chromate octahydroxide EC / List no: 256-418-0 | CAS no: 49663-84-5
Potassium hydroxyoctaoxodizincatedichromate(1-) EC / List no: 234-329-8 | CAS no: 11103-86-9
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Carc. 1A; Acute Tox. 4; Skin Sens. 1
425-240-7
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Eye Dam. 1
936-037-2
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yes
203-770-8
110-46-3
Flam. Liq. 2; Acute Tox. 4
430-460-1
133636-82-5
Skin Corr. 1B; Skin Sens. 1
432-360-3
105813-13-6
Acute Tox. 4; Skin Sens. 1
BRL 29226
406-030-4
105812-81-5
Acute Tox. 4; Eye Dam. 1
214-619-0
1166-46-7
Carc. 2; Acute Tox. 4; STOT SE 2
KELCOR; LIPOKEL; SEQUOL
425-230-2
16610-63-2
Skin Corr. 1B
CP-84,203-4; DFX-5S
411-000-9
125224-62-6
Skin Sens. 1
-
135821-03-3
yes
-
135821-74-8
yes
426-200-1
172015-79-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
BLUE 10 25 964
407-240-9
159604-94-1
Skin Sens. 1
439-360-2
142877-45-0
Skin Irrit. 2; Eye Dam. 1
430-910-7
13335-71-2
Acute Tox. 4; Eye Dam. 1
BUTAMINONITRODARONE; SR33581
444-800-1
141645-23-0
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
433-820-6
118058-74-5
Eye Irrit. 2
822-682-6
1417782-03-6
Skin Sens. 1
CIN 10094329; SENSIBILISATOR KF 693 PINA; SENSITIZER KF 693 PINA
422-240-9
166596-68-5
Eye Dam. 1; Skin Sens. 1
701-394-3
1782069-81-1
yes
420-380-5
136465-81-1
Acute Tox. 4; Eye Dam. 1
444-350-6
133413-70-4
Eye Irrit. 2
PTH-AA
430-230-0
136522-17-3
Acute Tox. 4
PHOTOAMORCEUR 22074; RHODORSIL PHOTOINITIATOR 2074; TEPBI
422-960-3
178233-72-2
Acute Tox. 4; STOT RE 2
SILANEOPHAN
405-020-7
105024-66-6
Repr. 1B
428-690-2
1668-86-6
Acute Tox. 4; Eye Irrit. 2
425-930-8
151213-39-7
Skin Corr. 1B; Acute Tox. 4; STOT RE 2
2691; CARTASOL BRILLANT SCHARLACH K-2GL KONZ.; CARTASOL BRILLANTSCHARLACH K-2GL FLÜSSIG (ZUBEREITUNG); CARTASOL BRILLANTSCHARLACH K-2GL GRANULAT (ZUBEREITUNG); CARTASOL BRILLIANT SCARLET K-2GL; CARTASOL BRILLIANT SCARLET K-2GL CONC.
402-060-7
108225-03-2
Carc. 1B; Eye Dam. 1
423-260-0
100988-63-4
Muta. 2; Skin Sens. 1
204-647-1
123-73-9
Flam. Liq. 2; Muta. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
DPP
410-980-5
112704-51-5
Eye Irrit. 2; Skin Sens. 1
PYRIDYLACROLEIN
426-330-9
177964-68-0
Eye Irrit. 2; Skin Sens. 1
423-240-1
125474-34-2
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
AOC 1020X
402-370-2
149057-70-5
Flam. Liq. 3; Eye Dam. 1
CARTASOL GEEL M-GL CONC.; CARTASOL GELB M-GL FLÜSSIG (ZUBEREITUNG); CARTASOL GELB M-GL KONZ.; CARTASOL YELLOW M-GL CONC.; HM 2580
401-500-5
118658-99-4
Carc. 1B
TICA 118
422-200-0
178277-55-9
Skin Corr. 1B; Acute Tox. 4
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178961-20-1
Skin Sens. 1
430-560-5
180637-89-2
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
UK-111,975
422-390-5
143322-57-0
Repr. 2; STOT RE 1; Acute Tox. 4; Skin Sens. 1
238-967-8
14898-79-4
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
236-232-6
13250-12-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
447-860-7
144177-62-8
Repr. 2; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
430-780-1
103146-25-4
Acute Tox. 4; Skin Sens. 1

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