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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 04 listopada 2024. Database contains 4821 unique substances/entries.
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203-870-1
111-44-4
Carc. 2; Acute Tox. 2; Acute Tox. 1
221-201-1
3030-47-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
DI(2-ETHYLHEXYL)DITHIODIGLYKOLAT; DP 327
404-510-8
62268-47-7
Acute Tox. 4; Skin Sens. 1
204-211-0
117-81-7
Repr. 1B
yes
430-700-5
10138-36-0
Skin Sens. 1
203-924-4
111-96-6
Flam. Liq. 3; Repr. 1B
yes
204-212-6
117-82-8
Repr. 1B
yes
BONTRON E-84; E-84
403-360-0
42405-40-3
Flam. Sol. 1; Acute Tox. 4
280-084-5
82985-35-1
Eye Dam. 1
DESMOPHEN VP-LS 2973 E; DESMOPHEN VP-LS 2975 E; DESMOPHEN VP-LS 2985 E
412-060-9
136210-32-7
Skin Sens. 1
404-420-9
71786-70-4
Skin Sens. 1
U 9649
401-380-4
89066-61-5
Eye Irrit. 2
200-237-1
55-55-0
Acute Tox. 4; STOT RE 2; Skin Sens. 1
INTEROX-PMBP-70W; INTEROX-PMPB-70W
407-950-9
895-85-2
Org. Perox. B
205-137-1
134-31-6
Acute Tox. 4
208-832-8
542-88-1
Flam. Liq. 2; Carc. 1A; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
276-205-6
71957-07-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Z-27
421-660-1
-
Eye Dam. 1; Skin Sens. 1
418-370-0
143925-92-2
Skin Sens. 1
233-118-8
10039-54-0
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
SAFRANIN SHMN
406-770-8
149057-64-7
STOT RE 2; Eye Dam. 1; Skin Sens. 1
239-703-4
15627-09-5
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
608-595-4
312600-89-8
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
GR101655A
423-170-1
618-26-8
Flam. Liq. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
214-604-9
1163-19-5
yes

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