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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 07 listopada 2024. Database contains 4821 unique substances/entries.
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UVA RAR 1018
423-520-3
156137-33-6
Skin Sens. 1
SALICYNALVA
423-460-8
3508-98-3
Acute Tox. 4
LEXQUAT AMG-BEO (CONCENTRATE)
423-420-1
136920-10-0
Eye Dam. 1; Skin Sens. 1
TEPIC-H
423-400-0
59653-74-6
Muta. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
CGI 819
423-340-5
162881-26-7
Skin Sens. 1A
TERTIARYBUTYLARSINE; TERTIÄRBUTYLARSIN
423-320-6
4262-43-5
Pyr. Liq. 1; Acute Tox. 2
423-310-1
61420-92-6
Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
423-300-7
911674-82-3
Skin Sens. 1
T 1569; T001569
423-290-4
66938-41-8
Muta. 2
423-260-0
100988-63-4
Muta. 2; Skin Sens. 1
423-240-1
125474-34-2
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
DIGLYCERINDIFORMAL (DGDF)
423-230-7
56552-15-9
Eye Dam. 1
REACTIVE RED 180 (HYDROLYSED)
423-200-3
98114-32-0
Eye Dam. 1; Skin Sens. 1
HFR-990
423-180-6
-
STOT RE 2
GR101655A
423-170-1
618-26-8
Flam. Liq. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
YELLOW JB 1238
423-110-4
-
Eye Dam. 1
423-100-1
-
Eye Dam. 1
423-010-0
-
Eye Dam. 1
ORANGE DER 8068
422-980-2
187026-95-5
Eye Dam. 1
PHOTOAMORCEUR 22074; RHODORSIL PHOTOINITIATOR 2074; TEPBI
422-960-3
178233-72-2
Acute Tox. 4; STOT RE 2
422-950-9
17193-28-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1
422-920-5
-
STOT RE 2
422-900-6
158894-67-8
Flam. Liq. 3; Carc. 2; Skin Corr. 1B; Skin Sens. 1
BROMIDE 182,780
422-850-5
148757-89-5
Skin Sens. 1
2-FLUOR-4-HYDROXYBENZONITRIL
422-810-7
82380-18-5
Acute Tox. 4; Eye Dam. 1

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