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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

RELEVANT LEGISLATION
Last updated 18 April 2024. Database contains 4821 unique substances/entries.
Filter the list

Page 5 of 97
50 Items per Page
Showing 201 - 250 of 4,821 results.
Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
fluoroacetates, soluble
-
-
Acute Tox. 2
fluorosilicates, with the exception of those specified elsewhere in this Annex
-
-
Acute Tox. 4
Fonsecaea compacta
-
-
F Fungi
Fonsecaea pedrosoi
-
-
F Fungi
Francisella tularensis (Type A)
-
-
B Bacteria and similar species
Francisella tularensis (Type B)
-
-
B Bacteria and similar species
Fusobacterium necrophorum
-
-
B Bacteria and similar species
Gardnerella vaginalis
-
-
B Bacteria and similar species
Germiston
-
-
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.
Gerstmann-Straussler-Scheinker syndrome
-
-
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.
Giardia lamblia
-
-
P Parasites
glass microfibres of representative composition [Calcium-aluminium-silicate fibres with random orientation with the following composition (% given by weight): SiO2 55,0-60,0 %, Al2O3 4,0-7,0 %, B2O3 8,0-11,0 %, ZrO2 0,0-4,0 %, Na2O 9,5-13,5 %, K2O 0,0-4,0 %, CaO 1,0-5,0 %, MgO 0,0-2,0 %, Fe2O3 < 0,2 %, ZnO 2,0-5,0 %, BaO 3,0-6,0 %, F2 < 1,0 %. Process: typically produced by flame attenuation and rotary process. (Additional individual elements may be present at low levels; the process list does not preclude innovation).]
-
-
Carc. 2
Guanarito virus
-
-
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.
Haemophilus ducreyi
-
-
B Bacteria and similar species
Haemophilus influenzae
-
-
B Bacteria and similar species
Haemophilus spp.
-
-
B Bacteria and similar species
Hantaan
-
-
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.
Hanzalova
-
-
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.
Hazara virus
-
-
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.
heazlewoodite
-
12035-71-1
Carc. 1A; Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
Helicobacter pylori
-
-
B Bacteria and similar species
Hepatitis A virus
-
-
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.
Hepatitis B virus
-
-
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.
Hepatitis C virus
-
-
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.
Hepatitis D virus
-
-
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.
Hepatitis E virus
-
-
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.
Hepatitis G virus
-
-
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.
Hepatitis viruses not yet identified
-
-
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.
Herpes simplex virus types 1 and 2
-
-
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.
Herpesvirus simiae
-
-
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.
Herpesvirus varicella-zoster
-
-
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.
hexachloroplatinates with the exception of those specified elsewhere in this Annex
show/hide
Diammonium hexachloroplatinate EC / List no: 240-973-0 | CAS no: 16919-58-7
Disodium hexachloroplatinate EC / List no: 240-983-5 | CAS no: 16923-58-3
Bis(benzyltrimethylammonium) hexachloroplatinate(2-) EC / List no: 255-585-7 | CAS no: 41909-89-1
Dihydrogen hexachloroplatinate, compound with 1,1,3,3-tetramethyl-1,3-divinyldisiloxane EC / List no: 258-092-5 | CAS no: 52672-74-9
Dicesium hexachloroplatinate EC / List no: 240-945-8 | CAS no: 16902-25-3
Chloroplatinic acid hexahydrate EC / List no: 629-612-1 | CAS no: 18497-13-7
Natriumchloroplatinat EC / List no: 626-326-9 | CAS no: 19583-77-8
Platinate(2-), hexachloro-, (OC-6-11)-, dihydrogen, reaction products with 2,4,6,8-tetraethenyl-2,4,6,8-tetramethylcyclotetrasiloxane EC / List no: 271-555-6 | CAS no: 68585-32-0
Platinate(2-), hexachloro-, (OC-6-11)-, dihydrogen, reaction products with tributylphosphine hydrochloride and N-(3-(trimethoxysilyl)propyl)-1,2-ethanediamine EC / List no: - | CAS no: 67924-25-8
Hexachloroplatinic acid EC / List no: 241-010-7 | CAS no: 16941-12-1
Hexachloroplatinate(2-) EC / List no: - | CAS no: 16871-54-8
Dipotassium hexachloroplatinate EC / List no: 240-979-3 | CAS no: 16921-30-5
Platinate(2-), hexachloro-, dihydrogen, (OC-6-11)-, reaction products with palladium EC / List no: - | CAS no: 68516-04-1
-
-
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
hexane (containing < 5% n-hexane (203-777-6))
-
-
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
Histoplasma capsulatum duboisii
-
-
F Fungi
Histoplasma capsulatum var. capsulatum
-
-
F Fungi
Human B-lymphotropic virus
-
-
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.
Human herpes virus 7
-
-
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.
Human herpes virus 8
-
-
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.
Human immunodeficiency viruses
-
-
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.
Human papillomaviruses
-
-
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.
Human parvovirus
-
-
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.
Human rotaviruses
-
-
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.
Human T-cell lymphotropic viruses, types 1 and 2
-
-
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.
Hymenolepis diminuta
-
-
P Parasites
Hymenolepis nana
-
-
P Parasites
Hypr
-
-
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.
Influenza viruses types A, B and C
-
-
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.
Inorganic compounds of mercury with the exception of mercuric sulphide and those specified elsewhere in this Annex
-
-
Acute Tox. 2; Acute Tox. 1; STOT RE 2
iodoxybenzene
-
696-33-3
Expl.
ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol
-
115937-89-8
Repr. 1B; Acute Tox. 4; STOT RE 2
Page 5 of 97
50 Items per Page
Showing 201 - 250 of 4,821 results.

Export search results to: