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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 srpnja 2024. Database contains 4821 unique substances/entries.
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GA1270; HOE S 4096
407-290-1
-
Eye Dam. 1
430-690-2
52783-21-8
Skin Irrit. 2
426-530-6
-
Skin Irrit. 2
HFR-990
423-180-6
-
STOT RE 2
427-040-5
-
Skin Corr. 1B
BLENDUR I VP KU 3-4519
421-550-1
-
Carc. 1B; Repr. 1B; Skin Sens. 1
433-640-8
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Pyr. Sol. 1
442-480-8
-
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
LOVASTATIN FREE ACID
415-840-7
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Skin Sens. 1
HOSTACOR 4205 CONC.; HOSTACOR V 4205
413-500-2
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Skin Irrit. 2; Eye Dam. 1
425-530-3
98769-75-6
Acute Tox. 4; Eye Dam. 1
434-290-9
249630-78-2
Acute Tox. 4
429-860-9
86803-90-9
Skin Sens. 1
SPIRAMBRENE
416-930-9
121251-67-0
Skin Irrit. 2
MS6119
415-190-4
-
Skin Sens. 1
EVERSORB 80; TINUVIN 1130; TINUVIN 213
400-830-7
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Skin Sens. 1
436-890-6
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Eye Dam. 1
MPA
402-090-0
87025-52-3
Skin Corr. 1B
ROBAC AS/100
403-030-6
137398-54-0
Acute Tox. 4; Skin Sens. 1
ETHOXYLATED POLYESTER RESIN
405-960-8
-
Skin Sens. 1
430-200-7
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Eye Dam. 1
EMULGATOR SWA; EMULVIN SWA
406-325-8
-
Acute Tox. 4
UNISOL S
405-760-0
-
Eye Dam. 1; Skin Sens. 1
SUBSTANCE S166075
424-270-8
-
Eye Dam. 1
MCP 968
410-190-0
132983-41-6
Eye Irrit. 2

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