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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 28 března 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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P Parasites
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P Parasites
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B Bacteria and similar species
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B Bacteria and similar species
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P Parasites
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Acute Tox. 4
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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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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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Carc. 1B
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Octadecanoic acid, beryllium salt EC / List no: - | CAS no: 16687-38-0
Beryllium selenide EC / List no: 235-450-9 | CAS no: 12232-25-6
Disodium tetrafluoroberyllate EC / List no: 237-630-2 | CAS no: 13871-27-7
Beryllium acetylide EC / List no: 208-050-7 | CAS no: 506-66-1
Beryllium chloride EC / List no: 232-116-4 | CAS no: 7787-47-5
Beryllium hexaboride EC / List no: 235-657-4 | CAS no: 12429-94-6
Nitric acid, beryllium salt, tetrahydrate EC / List no: 690-699-4 | CAS no: 13510-48-0
Beryllium zinc silicate EC / List no: 247-151-0 | CAS no: 25638-88-4
Phosphoric acid, beryllium salt EC / List no: 252-356-3 | CAS no: 35089-00-0
Beryllium oxyfluoride EC / List no: - | CAS no: 63990-88-5
Triberyllium nitride EC / List no: 215-132-6 | CAS no: 1304-54-7
Bis(pentane-2,4-dionato-O,O')beryllium EC / List no: 233-513-5 | CAS no: 10210-64-7
Beryllium hydroxide EC / List no: 236-368-6 | CAS no: 13327-32-7
Diethylberyllium EC / List no: 208-823-9 | CAS no: 542-63-2
Beryllium sulphide EC / List no: 237-064-6 | CAS no: 13598-22-6
Beryllium telluride EC / List no: 235-451-4 | CAS no: 12232-27-8
Tetraberyllium boride EC / List no: 235-695-1 | CAS no: 12536-52-6
Beryllium phosphide EC / List no: 261-137-1 | CAS no: 58127-61-0
Beryllium nitrate trihydrate EC / List no: - | CAS no: 7787-55-5
Beryllium nitrate EC / List no: 237-062-5 | CAS no: 13597-99-4
Copper alloy, Cu 96, Be 2.2-2.8, Ni 1.1 (CDA 827) EC / List no: - | CAS no: 11108-64-8
Beryllium EC / List no: 231-150-7 | CAS no: 7440-41-7
Beryllium sulphate EC / List no: 236-842-2 | CAS no: 13510-49-1
Aluminium alloy, Al,Be EC / List no: 603-236-8 | CAS no: 12770-50-2
Zinc beryllium silicate EC / List no: - | CAS no: 39413-47-3
Steel manufacture, chemicals
This category includes the chemical substances which are manufactured as part of steel and alloy steels. The following list identifies those elements which may exist in steel or which may comprise compounds present in steel or alloy steels. Aluminum, beryllium, boron, calcium, carbon, cerium, chromium, cobalt, copper, hafnium, iron, lanthanum, lead, magnesium, manganese, molybdenum, nickel, niobium, nitrogen, oxygen, phosphorus, selenium, silicon, sulfur, tantalum, tin, titanium, tungsten, vanadium, yttrium, zinc, zirconium.
EC / List no: 266-048-1 | CAS no: 65997-19-5
Beryllium dibromide EC / List no: 232-115-9 | CAS no: 7787-46-4
Hexakis[μ-(acetato-O:O')]-μ4-oxotetraberyllium EC / List no: 242-785-4 | CAS no: 19049-40-2
Beryllium phosphide (BeP2) EC / List no: - | CAS no: 1268721-56-7
Beryllium diiodide EC / List no: 232-119-0 | CAS no: 7787-53-3
Bertrandite (Be4(OH)2O(SiO3)2) EC / List no: 235-299-9 | CAS no: 12161-82-9
Silicic acid, beryllium salt EC / List no: 261-293-0 | CAS no: 58500-38-2
Beryllium di(acetate) EC / List no: 208-850-6 | CAS no: 543-81-7
Beryllium hydrogen phosphate (1:1) EC / List no: - | CAS no: 13598-15-7
Beryllium diboride EC / List no: 235-694-6 | CAS no: 12536-51-5
Beryllium diboride EC / List no: 235-443-0 | CAS no: 12228-40-9
Beryllium orthosilicate EC / List no: 239-251-8 | CAS no: 15191-85-2
Beryllium diammonium tetrafluoride EC / List no: 238-948-4 | CAS no: 14874-86-3
Beryllium sulfate tetrahydrate EC / List no: 629-461-1 | CAS no: 7787-56-6
Phosphoric acid, beryllium salt (2:3) EC / List no: - | CAS no: 13598-26-0
Beryllium carbonate EC / List no: 236-030-8 | CAS no: 13106-47-3
Beryllium fluoride EC / List no: 232-118-5 | CAS no: 7787-49-7
Beryllium, bis(carbonato(2-))dihydroxytri- EC / List no: - | CAS no: 66104-24-3
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Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 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.
Z-27
421-660-1
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Eye Dam. 1; Skin Sens. 1
421-560-6
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STOT RE 2; Eye Dam. 1
TK 10891; XB 4458; XW 528; ZK XB 4458
405-635-0
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Skin Irrit. 2; 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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F Fungi
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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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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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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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P Parasites
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P Parasites
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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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Acute Tox. 4
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yes
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Expl.
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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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F Fungi
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F Fungi
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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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