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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 09 rujna 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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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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F Fungi
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F Fungi
219-698-5
2499-95-8
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
257-074-4
51235-04-2
Acute Tox. 4; Eye Irrit. 2
NATRIUMMETAWOLFRAMAT
412-770-9
12141-67-2
Acute Tox. 4; Eye Dam. 1
BRUN REACTIF 45; BRUNO REATTIVO 45; C.I. REACTIVE BROWN 45; CIBACROM BROWN 1347; CIBACRON BROWN 1347; REACTIVE BRAUN 45
401-650-1
85665-96-9
Skin Sens. 1
C.I. BLEU REACTIF 204; C.I. REACTIVE BLUE 204; REACTIVE BLUE 204; REAKTIV BLAU 204
400-050-7
85153-92-0
Resp. Sens. 1; Skin Sens. 1
RED SF-PE 3534
410-180-6
157627-99-1
Eye Dam. 1
BRIGHTENER SM 1018 CONC.; LEUCOPHOR BCR
405-280-1
76508-02-6
Eye Irrit. 2
PROCION EMERALD H-EXL COLOUR; SUBSTANCE S156718
417-250-5
151436-99-6
Eye Dam. 1; Skin Sens. 1
247-143-7
25637-27-8
Acute Tox. 4
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Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
203-523-4
107-83-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-731-1
591-78-6
Flam. Liq. 3; Repr. 2; STOT RE 1; STOT SE 3
203-852-3
111-27-3
Acute Tox. 4
211-653-8
680-31-9
Carc. 1B; Muta. 1B
204-679-6
124-09-4
Acute Tox. 4; STOT SE 3; Skin Corr. 1B
212-485-8
822-06-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
235-921-9
13048-33-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
DIRECT RED 227, TETRAMETHYLAMMONIUM SALT
405-160-9
124537-30-0
Acute Tox. 3; Skin Sens. 1
AMINAZA TOLFAMATATE
418-350-1
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Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
204-127-4
116-15-4
Press. Gas; Acute Tox. 4; STOT SE 3
HEXACONAZOLE
413-050-7
79983-71-4
Acute Tox. 4; Skin Sens. 1
241-010-7
16941-12-1
Acute Tox. 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
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Dipotassium hexachloroplatinate EC / List no: 240-979-3 | CAS no: 16921-30-5
Hexachloroplatinate(2-) EC / List no: - | CAS no: 16871-54-8
Bis(benzyltrimethylammonium) hexachloroplatinate(2-) EC / List no: 255-585-7 | CAS no: 41909-89-1
Hexachloroplatinic acid EC / List no: 241-010-7 | CAS no: 16941-12-1
Sodium hexachloroplatinate(IV) hexahydrate EC / List no: 626-326-9 | CAS no: 19583-77-8
Disodium hexachloroplatinate EC / List no: 240-983-5 | CAS no: 16923-58-3
Chloroplatinic acid hexahydrate EC / List no: 629-612-1 | CAS no: 18497-13-7
Diammonium hexachloroplatinate EC / List no: 240-973-0 | CAS no: 16919-58-7
Dicesium hexachloroplatinate EC / List no: 240-945-8 | CAS no: 16902-25-3
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Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
201-029-3
77-47-4
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
204-273-9
118-74-1
Carc. 1B; STOT RE 1
204-129-5
116-16-5
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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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.
245-737-0
23560-59-0
Acute Tox. 3
203-838-7
111-14-8
Skin Corr. 1B
205-563-8
142-82-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
204-608-9
123-19-3
Flam. Liq. 3; Acute Tox. 4
203-388-1
106-35-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2
203-767-1
110-43-0
Flam. Liq. 3; Acute Tox. 4
213-831-0
1024-57-3
Carc. 2; Acute Tox. 3; STOT RE 2
200-962-3
76-44-8
Carc. 2; Acute Tox. 3; STOT RE 2
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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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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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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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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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