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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 10 rujna 2024. Database contains 4821 unique substances/entries.
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202-442-1
95-70-5
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
202-441-6
95-69-2
Carc. 1B; Muta. 2; Acute Tox. 3
202-439-5
95-65-8
Acute Tox. 3; Skin Corr. 1B
202-436-9
95-63-6
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-433-2
95-57-8
Acute Tox. 4
202-431-1
95-55-6
Muta. 2; Acute Tox. 4
202-430-6
95-54-5
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
202-429-0
95-53-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2
yes
202-425-9
95-50-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-424-3
95-49-8
Acute Tox. 4
202-423-8
95-48-7
Acute Tox. 3; Skin Corr. 1B
202-422-2
95-47-6
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
202-411-2
95-33-0
Skin Sens. 1
202-388-9
95-06-7
Carc. 1B; Acute Tox. 4
202-377-9
94-96-2
Eye Dam. 1
202-366-9
94-82-6
Acute Tox. 4
202-361-1
94-75-7
Acute Tox. 4; STOT SE 3; Eye Dam. 1; Skin Sens. 1
202-360-6
94-74-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
202-356-4
94-70-2
Acute Tox. 3; STOT RE 2
202-345-4
94-59-7
Carc. 1B; Muta. 2; Acute Tox. 4
202-328-1
94-37-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
202-327-6
94-36-0
Org. Perox. B; Eye Irrit. 2; Skin Sens. 1
202-318-7
94-26-8
yes
202-273-3
93-76-5
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-272-8
93-75-4
Acute Tox. 4
202-271-2
93-72-1
Acute Tox. 4; Skin Irrit. 2
202-270-7
93-71-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
202-214-1
93-05-0
Acute Tox. 3; Skin Corr. 1B
202-204-7
92-93-3
Carc. 1B
202-199-1
92-87-5
Carc. 1A; Acute Tox. 4
202-177-1
92-67-1
Carc. 1A; Acute Tox. 4
yes
202-163-5
92-52-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-155-1
92-43-3
Acute Tox. 4
202-128-4
92-13-7
Acute Tox. 2
202-110-6
91-95-2
Carc. 1B; Muta. 2
202-109-0
91-94-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
202-095-6
91-76-9
Acute Tox. 4
202-088-8
91-66-7
Acute Tox. 3; STOT RE 2
202-080-4
91-59-8
Carc. 1A; Acute Tox. 4
202-075-7
91-53-2
Acute Tox. 4
202-052-1
91-23-6
Carc. 1B; Acute Tox. 4
202-051-6
91-22-5
Carc. 1B; Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
202-049-5
91-20-3
Carc. 2; Acute Tox. 4
202-039-0
91-08-7
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
202-027-5
90-94-8
Carc. 1B; Muta. 2; Eye Dam. 1
yes
202-013-9
90-72-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
201-993-5
90-43-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-990-9
90-41-5
Carc. 2; Acute Tox. 4

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