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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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INTERMEDIAIRE AR HT 3728
410-065-0
-
Skin Sens. 1
MONO 442
412-260-6
52658-19-2
Eye Irrit. 2; Skin Sens. 1
611-341-5
55965-84-9
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
BONJET BLACK 817
418-230-9
163879-69-4
Expl. 1.3; Repr. 2; STOT RE 2; Skin Sens. 1
T-4240 FLUOROCHEMICAL URETHANE DERIVATIVE
413-640-4
-
STOT RE 2
427-730-6
202420-04-0
Skin Corr. 1B
451-440-9
586372-44-3
Eye Dam. 1
RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS
417-470-1
-
Muta. 2; Skin Sens. 1
R 7623 TECHNICAL
403-250-2
-
Carc. 2; Repr. 1B; Acute Tox. 4
423-750-4
-
Eye Irrit. 2
T-69
414-770-4
140698-96-0
Self-react. C; Carc. 2
CASSIFFIX
422-040-1
426218-78-2
Eye Irrit. 2; Skin Irrit. 2
427-050-1
-
Repr. 2; Skin Irrit. 2; Skin Sens. 1
-
8069-76-9
Acute Tox. 4
34 DIAZO
417-080-1
-
Self-react. D; Skin Sens. 1
NEOCASPIRENE
412-460-3
89079-92-5
Skin Irrit. 2
FORMYLTRICYCLODECEN, EXO
410-480-7
-
Skin Sens. 1
431-440-5
-
Eye Dam. 1
DISPERSIONSROT 2754
411-880-4
-
Skin Sens. 1
435-440-6
-
Eye Dam. 1
442-290-5
457624-86-1
Eye Dam. 1
440-510-4
-
Eye Dam. 1; Skin Sens. 1
ROT Y; RUBINOT Y; RUBINROT Y
408-240-1
-
Acute Tox. 4
ACRYLSKUM; T-2816 FOAMER
407-810-7
-
STOT RE 2
425-910-9
32480-08-3
Skin Irrit. 2

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