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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 25 lipnja 2024. Database contains 4821 unique substances/entries.
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605-037-1
156052-68-5
Skin Sens. 1
605-015-1
155569-91-8
Acute Tox. 3; STOT SE 1; STOT RE 1; Eye Dam. 1
604-715-4
149979-41-9
Carc. 2; Repr. 2
604-712-8
149961-52-4
Carc. 2; Repr. 2; Acute Tox. 4
604-636-5
148477-71-8
Carc. 1B; Repr. 2; STOT RE 2; Skin Sens. 1B
604-430-5
144651-06-9
STOT RE 2
604-398-2
144171-61-9
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
604-395-6
14409-72-4
yes
604-351-6
143390-89-0
Carc. 2
604-318-6
142891-20-1
Carc. 2; Skin Sens. 1
604-314-4
142844-00-6
yes
604-291-0
142469-14-5
Skin Sens. 1
604-290-5
142459-58-3
Acute Tox. 4; STOT RE 2; Skin Sens. 1
604-237-6
141517-21-7
Lact.; Skin Sens. 1
604-222-4
141112-29-0
Repr. 2
604-209-3
140923-17-7
Carc. 2
604-167-6
139968-49-3
Repr. 2; Lact.; STOT RE 2
604-105-8
139001-49-3
Carc. 2; Repr. 2; Skin Sens. 1
603-921-1
135410-20-7
Acute Tox. 4
603-902-8
13517-20-9
yes
603-902-8
13517-20-9
Repr. 1B; STOT SE 3; Eye Dam. 1
603-902-8
13517-20-9
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
603-804-5
134237-52-8
yes
603-802-4
134237-51-7
yes
603-801-9
134237-50-6
yes
603-792-1
134098-61-6
Acute Tox. 3; Acute Tox. 2; Skin Sens. 1B
603-524-3
131860-33-8
Acute Tox. 3
603-520-1
131807-57-3
STOT RE 2
603-411-9
1303-96-4
Repr. 1B
yes
603-404-0
130328-20-0
Repr. 2; Skin Irrit. 2; Eye Dam. 1
603-146-9
126535-15-7
Carc. 2
603-038-1
125225-28-7
Repr. 1B; Acute Tox. 4; STOT RE 2
603-031-3
125116-23-6
Repr. 2; Acute Tox. 4
602-997-3
124495-18-7
Skin Sens. 1
602-929-2
123333-53-9
Expl. 1.3
602-927-1
123312-89-0
Carc. 2; Repr. 2
602-894-3
12280-03-4
Repr. 1B
602-782-4
122453-73-0
Acute Tox. 3; Acute Tox. 4
601-810-2
12185-10-3
Pyr. Sol. 1; Acute Tox. 2; Skin Corr. 1A
601-808-1
12179-04-3
Repr. 1B
yes
601-801-3
12172-73-5
Carc. 1A; STOT RE 1
601-785-8
121552-61-2
Skin Sens. 1
601-650-3
12001-29-5
Carc. 1A; STOT RE 1
601-649-8
12001-28-4
Carc. 1A; STOT RE 1
601-585-0
119168-77-3
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1B
601-505-4
118134-30-8
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
601-305-7
114311-32-9
Repr. 2
601-147-9
111988-49-9
Carc. 2; Repr. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3
600-765-6
106700-29-2
Acute Tox. 4; Skin Sens. 1
600-662-6
105512-06-9
Acute Tox. 4; STOT RE 2; Skin Sens. 1

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