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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
FEKPDTA; KFEPDTA
405-680-6
148434-01-9
Self-heat. 2
234-329-8
11103-86-9
yes
215-181-3
1310-58-3
Acute Tox. 4; Skin Corr. 1A
231-594-1
7646-93-7
Skin Corr. 1B; STOT SE 3
232-151-5
7789-23-3
Acute Tox. 3
430-010-4
12160-44-0
Skin Corr. 1B; Skin Sens. 1
213-029-0
917-58-8
Self-heat. 1; Skin Corr. 1B
231-906-6
7778-50-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
209-676-3
590-28-3
Acute Tox. 4
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
yes
223-289-7
3811-04-9
Ox. Sol. 1; Acute Tox. 4
231-829-8
7758-01-2
Ox. Sol. 1; Carc. 1B; Acute Tox. 3
CHEMICAL CHELATING AGENT #2
411-640-9
153352-59-1
Acute Tox. 4
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
426-620-5
619297-89-1
Eye Dam. 1
V67282
406-500-9
174393-75-0
Skin Sens. 1
426-300-5
-
Eye Dam. 1
233-002-7
10007-85-9
Eye Irrit. 2
AZYLACID-POTASSIUMSALT
401-630-2
96566-70-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
KLOBENPROP
426-350-8
138666-92-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
FLEXSORB HP SOLID; MALINE K
405-560-3
120447-91-8
Acute Tox. 4; Skin Corr. 1A
DUPLOSAN-DP-KALIUM
413-580-9
113963-87-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
POTASSIUM 2,5-DICHLOROBENZOATE
415-700-5
184637-62-5
Acute Tox. 4; Eye Dam. 1

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