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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 21 lipnja 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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B Bacteria and similar species
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B Bacteria and similar species
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F Fungi
418-270-7
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Skin Sens. 1
414-910-4
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Eye Dam. 1; Skin Sens. 1
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B Bacteria and similar species
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yes
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Phenol, (tetrapropenyl) derivatives EC / List no: 616-100-8 | CAS no: 74499-35-7
[No public or meaningful name is available] EC / List no: - | CAS no: 27459-10-5
Phenol, 4-isododecyl- EC / List no: 608-055-8 | CAS no: 27147-75-7
Phenol, tetrapropylene- EC / List no: - | CAS no: 57427-55-1
Phenol, 4-dodecyl, branched EC / List no: 640-104-9 | CAS no: 210555-94-5
Phenol, dodecyl-, branched EC / List no: 310-154-3 | CAS no: 121158-58-5
799-972-3
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yes
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yes
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P Parasites
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P Parasites
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B Bacteria and similar species
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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.
RX-33
419-590-1
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Flam. Sol. 1; Skin Sens. 1
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B Bacteria and similar species
426-300-5
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Eye Dam. 1
REAKTIVROT 2713
412-490-7
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Skin Sens. 1
C.I. REACTIVE RED 231
402-150-6
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Eye Irrit. 2; Skin Sens. 1
425-830-4
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Eye Dam. 1
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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
BROWN JR 547
419-260-5
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Eye Dam. 1
425-740-5
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Eye Dam. 1
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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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B Bacteria and similar species
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B Bacteria and similar species
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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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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.
BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763
404-540-1
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Skin Sens. 1
DESBIMID
401-970-1
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Skin Sens. 1
KAYARAD R-825
405-360-6
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
ADINE CP 31
401-740-0
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Acute Tox. 4
915-270-3
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yes
PK 323
401-940-8
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Acute Tox. 4; Eye Irrit. 2
X 3761
400-930-0
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
BROWN JR 543
414-150-3
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Skin Sens. 1
SUBSTANCE S166075
424-270-8
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Eye Dam. 1
UNISOL S
405-760-0
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Eye Dam. 1; Skin Sens. 1
EMULGATOR SWA; EMULVIN SWA
406-325-8
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Acute Tox. 4
430-200-7
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Eye Dam. 1
ETHOXYLATED POLYESTER RESIN
405-960-8
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Skin Sens. 1
436-890-6
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Eye Dam. 1
EVERSORB 80; TINUVIN 1130; TINUVIN 213
400-830-7
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Skin Sens. 1

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