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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 rujna 2024. Database contains 4821 unique substances/entries.
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Stranica 3 od 97
50 Broj stavki po stranici
Prikaz 101 - 150 od 4.821 rezultata.
Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
Salmonella (other serovars)
-
-
B Bacteria and similar species
Sabia 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.
S-(tricyclo(5.2.1.0'2,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate
X4261
401-850-9
255881-94-8
yes
Russian spring-summer encephalitis
-
-
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.
Rubivirus
-
-
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.
Ross River 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.
Rocio
-
-
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.
Rift Valley fever
-
-
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.
Rickettsia typhi
-
-
B Bacteria and similar species
Rickettsia tsutsugamushi
-
-
B Bacteria and similar species
Rickettsia spp.
-
-
B Bacteria and similar species
Rickettsia rickettsii
-
-
B Bacteria and similar species
Rickettsia prowazekii
-
-
B Bacteria and similar species
Rickettsia montana
-
-
B Bacteria and similar species
Rickettsia conorii
-
-
B Bacteria and similar species
Rickettsia canada
-
-
B Bacteria and similar species
Rickettsia akari
-
-
B Bacteria and similar species
Rhodococcusequi
-
-
B Bacteria and similar species
Rhinoviruses
-
-
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.
Reuviruses
-
-
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.
Respiratory syncytial 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.
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP)
939-460-0
1471311-26-8
yes
Reaction product of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and phenol, heptyl derivs.
-
-
yes
Reaction mass of 5-(sec-butyl)-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane and 5-(sec-butyl)-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane;Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
413-720-9
117933-89-8
yes
Reaction mass of 5-(sec-butyl)-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane and 5-(sec-butyl)-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane;Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
413-720-9
117933-89-8
yes
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate; reaction mass of DOTE and MOTE
915-270-3
-
yes
Rabies 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.
Rabbitpox 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.
Pyrochlore, antimony lead yellow
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
yes
Pyrene
204-927-3
129-00-0
yes
Puumala 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.
Pseudomonas aeruginosa
-
68583-29-9
B Bacteria and similar species
Providencia spp.
-
-
B Bacteria and similar species
Providencia rettgeri
-
-
B Bacteria and similar species
Providencia alcalifaciens
-
-
B Bacteria and similar species
Proteus vulgaris
-
-
B Bacteria and similar species
Proteus penneri
-
-
B Bacteria and similar species
Proteus mirabilis
-
-
B Bacteria and similar species
Prospect Hill 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.
Prevotella spp.
-
-
B Bacteria and similar species
Powassan
-
-
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.
Potassium perfluorohexane-1-sulphonate
223-393-2
3871-99-6
yes
Potassium hydroxyoctaoxodizincatedichromate
234-329-8
11103-86-9
yes
Potassium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionate
266-578-3
67118-55-2
yes
Porphyromonas spp.
-
-
B Bacteria and similar species
Polyethylene glycol mono(tert-octylph-enyl) ether9036-19-5
618-541-1
9036-19-5
yes
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
Plasmodium spp. (human and simian)
-
-
P Parasites
Plasmodium falciparum
-
-
P Parasites
Stranica 3 od 97
50 Broj stavki po stranici
Prikaz 101 - 150 od 4.821 rezultata.

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