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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 svibnja 2024. Database contains 4821 unique substances/entries.
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601-305-7
114311-32-9
Repr. 2
428-040-8
138261-41-3
Acute Tox. 3
431-510-5
18087-70-2
Acute Tox. 4; Eye Irrit. 2
605-683-4
173584-44-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
216-881-1
1689-83-4
Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
603-038-1
125225-28-7
Repr. 1B; Acute Tox. 4; STOT RE 2
-
115850-69-6
Repr. 1B; Acute Tox. 4; STOT RE 2
-
115937-89-8
Repr. 1B; Acute Tox. 4; STOT RE 2
604-209-3
140923-17-7
Carc. 2
IVAX
401-920-9
100181-71-3
Skin Irrit. 2; Skin Sens. 1
203-745-1
110-19-0
Flam. Liq. 2
203-417-8
106-63-8
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
ZOLDINE RD-4
419-850-2
148348-13-4
Skin Corr. 1B
ALKYLSILANE TZ 01748; DYNASYLAN 9405; EURENOR(R) 5020; PSX 5305
402-580-4
111439-76-0
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
234-284-4
11066-49-2
yes
204-662-3
123-92-2
Flam. Liq. 3
203-769-2
110-45-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-322-1
105-68-0
Flam. Liq. 3
203-561-1
108-21-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-301-7
105-48-6
Flam. Liq. 3; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
417-970-1
1379932-74-7
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Dam. 1
431-540-9
170573-32-7
Skin Irrit. 2
604-222-4
141112-29-0
Repr. 2
242-624-8
18854-01-8
Acute Tox. 3
A complex combination of hydrocarbons obtained from the distillation of petroleum and subsequent hydrotreatment. It consists predominantly of alkanes, cycloalkanes and alkylbenzenes having carbon numbers predominantly in the range of C12 through C16 and boiling in the range of approximately 230°C to 270°C (446°F to 518°F).
309-944-0
101631-19-0
Asp. Tox. 1
604-351-6
143390-89-0
Carc. 2
215-630-3
1335-32-6
Carc. 2; Repr. 1A; STOT RE 2
237-486-0
13814-96-5
yes
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77605.
235-759-9
12656-85-8
Carc. 1B; Repr. 1A; STOT RE 2
yes
236-542-1
13424-46-9
Unst. Expl.; Repr. 1A; Acute Tox. 4; STOT RE 2
236-542-1
13424-46-9
yes
236-542-1
13424-46-9
Expl. 1.1; Repr. 1A; Acute Tox. 4; STOT RE 2
233-245-9
10099-74-8
yes
215-267-0
1317-36-8
yes
234-853-7
12036-76-9
yes
239-290-0
15245-44-0
yes
239-290-0
15245-44-0
Expl. 1.1; Repr. 1A; Acute Tox. 4; STOT RE 2
239-290-0
15245-44-0
Unst. Expl.; Repr. 1A; Acute Tox. 4; STOT RE 2
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.
215-693-7
1344-37-2
Carc. 1B; Repr. 1A; STOT RE 2
yes
235-038-9
12060-00-3
yes
235-727-4
12626-81-2
yes
BLEIMETHANSULFONAT; LEAD (II) METHANESULFONATE; LEAD METHANE SULPHONATE; LEAD SALT FP
401-750-5
17570-76-2
Repr. 1A; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
yes
204-961-9
129-73-7
Carc. 2; Muta. 2
204-811-2
126-91-0
Skin Sens. 1B
BLUE 14 52 200
411-140-0
125328-86-1
Eye Dam. 1; Skin Sens. 1
LI-BIT
411-690-1
111337-53-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
620-400-4
12031-65-1
Carc. 1A; STOT RE 1; Skin Sens. 1
ACID RED FC 70013
414-250-7
149564-66-9
Acute Tox. 4; Eye Dam. 1
429-730-1
193562-37-7
Eye Dam. 1; Skin Sens. 1
REACTIVE BLUE FC 05 717
401-560-2
108624-00-6
Skin Sens. 1

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