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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 lipnja 2024. Database contains 4821 unique substances/entries.
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425-240-7
-
Eye Dam. 1
417-130-2
1379689-21-0
Eye Dam. 1
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
PC-709
413-420-8
144736-29-8
Skin Corr. 1B; Skin Sens. 1
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
500-036-1
25214-70-4
yes
1 - 2.5 moles ethoxylated
500-209-1
68412-54-4
yes
500-024-6
9016-45-9
yes
500-033-5
25068-38-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
692-456-8
688046-61-9
Carc. 2
616-221-6
7541-49-3
Skin Irrit. 2
602-929-2
123333-53-9
Expl. 1.3
620-419-8
606-35-9
Expl. 1.1; Acute Tox. 4
618-344-0
9002-93-1
yes
687-832-3
1119449-37-4
yes
695-989-4
2527-66-4
Acute Tox. 4; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
687-833-9
1119449-38-5
yes
604-395-6
14409-72-4
yes
606-640-2
2079-00-7
Acute Tox. 2
620-358-7
140-41-0
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
620-041-3
907204-31-3
Lact.
622-370-8
1522-92-5
yes
621-341-7
2315-61-9
yes
635-388-6
521947-27-3
yes
635-389-1
186825-36-5
yes
635-391-2
142731-63-3
yes
635-696-0
186825-39-8
yes
608-055-8
27147-75-7;27459-10-5
yes
608-055-8
27147-75-7;27459-10-5
yes
621-345-9
2315-67-5
yes
619-823-7
494793-67-8
Carc. 2
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
615-339-5
71751-41-2
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
611-595-7
57960-19-7
Skin Sens. 1; STOT SE 1; STOT RE 2
603-921-1
135410-20-7
Acute Tox. 4
603-801-9
134237-50-6
yes
604-314-4
142844-00-6
yes
672-776-4
348635-87-0
Carc. 2; Eye Irrit. 2
601-801-3
12172-73-5
Carc. 1A; STOT RE 1
616-471-6
77536-66-4
Carc. 1A; STOT RE 1
616-473-7
77536-68-6
Carc. 1A; STOT RE 1
616-472-1
77536-67-5
Carc. 1A; STOT RE 1
601-649-8
12001-28-4
Carc. 1A; STOT RE 1
601-650-3
12001-29-5
Carc. 1A; STOT RE 1
620-425-0
68049-83-2
Repr. 1B; STOT RE 2
603-524-3
131860-33-8
Acute Tox. 3
620-403-0
8003-05-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
617-356-3
82560-54-1
Repr. 2; Acute Tox. 3; Acute Tox. 4
605-769-1
17606-31-4
Acute Tox. 4
691-719-4
1072957-71-1
Acute Tox. 3
603-802-4
134237-51-7
yes
617-373-6
82657-04-3
Carc. 2; Acute Tox. 3; Acute Tox. 2; STOT RE 1; Skin Sens. 1B
608-595-4
312600-89-8
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
616-932-1
8011-63-0
Acute Tox. 4; Eye Dam. 1
620-359-2
8065-36-9
Acute Tox. 3
640-998-0
7790-78-5
yes
618-392-2
9004-70-0
Expl. 1.1
602-782-4
122453-73-0
Acute Tox. 3; Acute Tox. 4
604-318-6
142891-20-1
Carc. 2; Skin Sens. 1
619-396-7
99129-21-2
Acute Tox. 4; Skin Sens. 1
600-662-6
105512-06-9
Acute Tox. 4; STOT RE 2; Skin Sens. 1
617-258-0
81777-89-1
Acute Tox. 4
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
620-377-0
13067-93-1
Acute Tox. 3; STOT SE 1; Acute Tox. 4; Eye Irrit. 2
642-974-5
400882-07-7
Carc. 2; Skin Sens. 1A
619-020-1
94361-06-5
Repr. 1B; Acute Tox. 3; STOT RE 2
601-785-8
121552-61-2
Skin Sens. 1
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2
686-814-2
34363-01-4
Skin Irrit. 2; Skin Sens. 1
620-404-6
7572-29-4
Unst. Expl.; Carc. 2; STOT RE 2
620-436-0
75736-33-3
Eye Irrit. 2
600-594-7
104653-34-1
Repr. 1B; Acute Tox. 1; STOT RE 1
605-329-9
163515-14-8
Acute Tox. 4; Skin Sens. 1
620-379-1
3254-63-5
Acute Tox. 1; Acute Tox. 2
604-712-8
149961-52-4
Carc. 2; Repr. 2; Acute Tox. 4
617-485-5
76714-88-0
Acute Tox. 4
620-422-4
4097-36-3
Acute Tox. 3
602-894-3
12280-03-4
Repr. 1B
603-411-9
1303-96-4
Repr. 1B
yes
601-808-1
12179-04-3
Repr. 1B
yes
605-015-1
155569-91-8
Acute Tox. 3; STOT SE 1; STOT RE 1; Eye Dam. 1
620-440-2
12510-42-8
Carc. 1A
613-911-9
66230-04-4
Acute Tox. 3; STOT SE 1; STOT RE 2; Skin Sens. 1
619-290-0
97780-06-8
Eye Irrit. 2
611-089-6
540-67-0
Flam. Gas 1; Press. Gas
603-520-1
131807-57-3
STOT RE 2
615-273-7
71283-80-2
STOT RE 2; Skin Sens. 1
603-792-1
134098-61-6
Acute Tox. 3; Acute Tox. 2; Skin Sens. 1B
605-127-0
158062-67-0
Acute Tox. 4
616-669-2
79241-46-6
Repr. 2
616-712-5
79622-59-6
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1A
604-290-5
142459-58-3
Acute Tox. 4; STOT RE 2; Skin Sens. 1
613-108-3
62924-70-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
600-425-7
103361-09-7
Repr. 2
617-717-5
85509-19-9
Carc. 2; Repr. 1B; Acute Tox. 4
614-346-0
68157-60-8
Carc. 2
619-377-3
98886-44-3
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
603-804-5
134237-52-8
yes

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