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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 08 listopada 2024. Database contains 4821 unique substances/entries.
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202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
GR101655A
423-170-1
618-26-8
Flam. Liq. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
263-125-1
61790-33-8
Acute Tox. 4; Asp. Tox. 1; STOT RE 2; Skin Corr. 1B
263-072-4
61789-60-4
Carc. 1B
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic hydrocarbons and may contain appreciable quantities of tar acids and tar bases. It distills at the approximate range of 200°C to 325°C (392°F to 617°F).
263-047-8
61789-28-4
Carc. 1B
263-004-3
61788-76-9
yes
262-977-1
61788-46-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
262-976-6
61788-45-2
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
262-967-7
61788-32-7
yes
262-967-7
61788-32-7
yes
432-560-0
61721-07-1
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
210-529-0
617-78-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
432-310-0
617-55-0
Flam. Liq. 3; Eye Dam. 1; Skin Sens. 1
228-200-5
6164-98-3
Carc. 2; Acute Tox. 4
210-484-7
616-47-7
Acute Tox. 4; Skin Corr. 1B
210-478-4
616-38-6
Flam. Liq. 2
210-467-4
616-20-6
Flam. Liq. 2; Acute Tox. 4
D(+)-LACTATE D'ISOBUTYLE
407-770-0
61597-96-4
Eye Irrit. 2
THTPA
407-330-8
61571-06-0
Repr. 1B; Eye Dam. 1
2,2'-AZOBIS(2-METHYL-N-(2-HYDROXYETHYL)PROPIONAMID)
429-090-3
61551-69-7
Skin Sens. 1
210-431-8
615-50-9
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
210-418-7
615-28-1
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
210-406-1
615-05-4
Carc. 1B; Muta. 2; Acute Tox. 4
262-784-2
61432-55-1
Acute Tox. 4
423-310-1
61420-92-6
Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1

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