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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 17 lipnja 2024. Database contains 4821 unique substances/entries.
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616-699-6
79538-32-2
Acute Tox. 1; Acute Tox. 2
616-669-2
79241-46-6
Repr. 2
616-584-0
7803-57-8
yes
616-572-5
7790-84-3
yes
616-541-6
7789-12-0
yes
616-510-7
7782-63-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
616-473-7
77536-68-6
Carc. 1A; STOT RE 1
616-472-1
77536-67-5
Carc. 1A; STOT RE 1
616-471-6
77536-66-4
Carc. 1A; STOT RE 1
616-379-6
76738-62-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
616-221-6
7541-49-3
Skin Irrit. 2
616-100-8
74499-35-7
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes
616-096-8
7446-19-7
Acute Tox. 4; Eye Dam. 1
615-339-5
71751-41-2
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
615-273-7
71283-80-2
STOT RE 2; Skin Sens. 1
615-135-6
70630-17-0
Acute Tox. 4; Eye Dam. 1
614-708-8
68694-11-1
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
614-346-0
68157-60-8
Carc. 2
614-054-3
67375-30-8
Acute Tox. 3; STOT RE 2; STOT SE 3
613-953-8
66603-10-9
Flam. Sol. 1; Acute Tox. 3; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
613-911-9
66230-04-4
Acute Tox. 3; STOT SE 1; STOT RE 2; Skin Sens. 1
613-108-3
62924-70-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
611-802-0
591-34-4
Flam. Liq. 3
611-595-7
57960-19-7
Skin Sens. 1; STOT SE 1; STOT RE 2
611-516-6
57369-32-1
Acute Tox. 4
611-341-5
55965-84-9
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
611-089-6
540-67-0
Flam. Gas 1; Press. Gas
610-700-3
51580-86-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
610-007-6
422556-08-9
Skin Sens. 1
609-346-2
37205-87-1
yes
608-879-8
335104-84-2
Repr. 2; STOT RE 2; Skin Sens. 1
608-723-9
32289-58-0
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
608-595-4
312600-89-8
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
608-492-4
3050-88-2
yes
608-055-8
27147-75-7;27459-10-5
yes
608-055-8
27147-75-7;27459-10-5
yes
608-042-7
27083-27-8
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
607-955-8
2655-14-3
Acute Tox. 4
607-329-4
24151-93-7
Acute Tox. 4
606-640-2
2079-00-7
Acute Tox. 2
606-566-0
20487-40-5
Flam. Liq. 2
606-523-6
203313-25-1
Repr. 2; STOT SE 3; Eye Irrit. 2; Skin Sens. 1A
606-168-7
189278-12-4
Carc. 2
605-769-1
17606-31-4
Acute Tox. 4
605-752-9
175217-20-6
STOT RE 2
605-747-1
175013-18-0
Acute Tox. 3; Skin Irrit. 2
605-683-4
173584-44-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
605-329-9
163515-14-8
Acute Tox. 4; Skin Sens. 1
605-127-0
158062-67-0
Acute Tox. 4

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