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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 11 listopada 2024. Database contains 4821 unique substances/entries.
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212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
CYASORB UV-3853 LIGHT STABILIZER; DASTIB 845; SANDUVOR 845
415-430-8
86403-32-9
Eye Dam. 1; Skin Sens. 1
DRIMAREN SCHARLACH X-GA 979; DRIMAREN SCHARLAKEN X-GA; DRIMAREN SCHARLAKEN X-GA 979; DRIMARENE SCARLET X-2 GN; ECARLATE DRIMARENE X-2GN; ECARLATE DRIMARENE X-GA 979; ECARLATE X-GA 979; SCARLET X-GA 979
400-380-1
86393-35-3
Skin Sens. 1
428-390-1
86393-34-2
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
FLUORCHINOLONCARBONSÄURE
405-050-0
86393-33-1
Acute Tox. 4
UK-51,060-01
412-390-3
86386-75-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
811-718-6
86347-14-0
Acute Tox. 2; STOT SE 3; STOT SE 1; STOT RE 1
A complex combination of hydrocarbons consisting primarily of paraffins, cycloparaffins, aromatic and olefinic hydrocarbons having carbon numbers predominantly greater than C3 and boiling in the range of 30°C to 260°C (86°F to 500°F).
289-220-8
86290-81-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
201-706-3
86-88-4
Acute Tox. 2; Carc. 2
201-676-1
86-50-0
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1

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