EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1
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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 02 listopada 2024. Database contains 4821 unique substances/entries.
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248-924-5
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28249-77-6
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Acute Tox. 4 |
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207-341-6
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463-71-8
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Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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207-337-4
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463-56-9
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Acute Tox. 4 |
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254-346-4
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39196-18-4
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Acute Tox. 1; Acute Tox. 2 |
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200-677-4
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68-11-1
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Acute Tox. 3; Skin Corr. 1B |
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211-362-6
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640-15-3
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Acute Tox. 3; Acute Tox. 4 |
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206-049-6
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297-97-2
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Acute Tox. 1; Acute Tox. 2 |
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RT 1766A
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404-820-3
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164637-97-2
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Skin Irrit. 2; Skin Sens. 1 |
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231-748-8
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7719-09-7
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Acute Tox. 4; Skin Corr. 1A |
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245-740-7
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23564-05-8
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Carc. 2; Muta. 2; Acute Tox. 4; Skin Sens. 1 |
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202-272-8
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93-75-4
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Acute Tox. 4 |
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200-543-5
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62-56-6
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Carc. 2; Repr. 2; Acute Tox. 4 |
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205-286-2
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137-26-8
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Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1 |
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201-944-8
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89-83-8
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Acute Tox. 4; Skin Corr. 1B |
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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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231-588-9
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7646-78-8
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Skin Corr. 1B |
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STANNOUS METHANE SULPHONAT; STANNOUS METHANE SULPHONATE; TIN (II) METHANE SULPHONATE; TIN METHANE SULPHONATE; TIN METHANESULFONATE; TIN SALT FS; ZINN(II) METHANESULFONATE; ZINN(II)-METHANSULFONAT
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401-640-7
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53408-94-9
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Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1 |
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236-675-5
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13463-67-7
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Carc. 2 |
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231-441-9
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7550-45-0
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Skin Corr. 1B |
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TITANYL OXALAAT
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403-260-7
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31363-92-5
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Eye Dam. 1 |
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260-515-3
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57018-04-9
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Skin Sens. 1B |
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203-625-9
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108-88-3
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Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3 |
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265-697-8
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65321-67-7
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Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1 |
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208-741-3
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540-25-0
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Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1 |
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208-740-8
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540-23-8
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Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1 |
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211-986-9
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731-27-1
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Acute Tox. 2; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1 |
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211-986-9
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731-27-1
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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. |
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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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204-854-7
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127-65-1
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Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1 |
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P Parasites |
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P Parasites |
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618-075-9
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87820-88-0
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Carc. 2; Acute Tox. 4 |
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FC4010
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417-290-3
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147086-81-5
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Acute Tox. 4 |
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AMINODIOXEPAN
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419-050-3
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79944-37-9
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Skin Sens. 1 |
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229-977-3
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6876-12-6
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Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1 |
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DHP OPT
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445-770-2
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42031-28-7
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Eye Dam. 1 |
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231-186-3
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7443-52-9
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Acute Tox. 4 |
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SQ28,646
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419-160-1
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90657-55-9
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Repr. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1 |
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SQ 27,616
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416-020-1
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96314-26-0
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Repr. 2; Skin Sens. 1 |
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205-860-2
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156-60-5
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Flam. Liq. 2; Acute Tox. 4 |
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250-517-2
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31218-83-4
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Acute Tox. 3 |
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443-150-6
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101226-85-1
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Flam. Liq. 3 |
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405-060-5
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118712-89-3
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Skin Irrit. 2 |
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BASIC YELLOW 105; C.I. BASIC YELLOW 105
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405-860-4
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121315-16-0
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Skin Sens. 1 |
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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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