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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 srpnja 2024. Database contains 4821 unique substances/entries.
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257-907-1
52427-13-1
yes
257-842-9
52315-07-8
Acute Tox. 4; STOT SE 3; STOT RE 2
257-842-9
52315-07-8
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
257-765-0
52234-82-9
Muta. 2; Eye Dam. 1; Skin Sens. 1
257-622-2
52033-74-6
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
257-447-1
51818-56-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
257-187-9
51414-25-6
Skin Sens. 1A
257-175-3
51404-69-4
yes
257-141-8
51338-27-3
Acute Tox. 4; Skin Sens. 1
257-074-4
51235-04-2
Acute Tox. 4; Eye Irrit. 2
256-960-8
51085-52-0
Carc. 2; Acute Tox. 3
256-814-3
50864-67-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
256-634-5
50594-66-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
256-625-6
50563-36-5
Acute Tox. 4; Skin Sens. 1
256-599-6
50471-44-8
Carc. 2; Repr. 1B; Skin Sens. 1
256-418-0
49663-84-5
yes
256-356-4
48122-14-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
256-152-5
43222-48-6
Acute Tox. 4
256-103-8
43121-43-3
Acute Tox. 4; Skin Sens. 1
256-032-2
42978-66-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
255-863-8
42509-80-8
Acute Tox. 2; Acute Tox. 3; STOT RE 2; Skin Sens. 1
255-853-3
42498-58-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
255-559-5
41814-78-2
Acute Tox. 4
255-391-2
41483-43-6
Carc. 2; Skin Sens. 1B
255-349-3
41394-05-2
Acute Tox. 4
255-255-2
41198-08-7
Acute Tox. 4
255-209-1
41083-11-8
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
254-938-2
40487-42-1
Skin Sens. 1
254-875-0
40292-82-8
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
254-642-3
39819-65-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
254-637-6
39807-15-3
Repr. 2; STOT RE 2
254-485-0
39515-41-8
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
254-408-0
39300-45-3
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
254-346-4
39196-18-4
Acute Tox. 1; Acute Tox. 2
254-323-9
39156-41-7
Carc. 1B; Muta. 2; Acute Tox. 4
254-320-2
39148-24-8
Eye Dam. 1
253-855-9
38260-54-7
Acute Tox. 4
253-718-3
37924-13-3
Acute Tox. 4; Eye Irrit. 2
253-704-7
37894-46-5
Repr. 1B; Acute Tox. 4; STOT RE 2
253-703-1
37893-02-0
Eye Irrit. 2
253-465-9
37329-65-0
Resp. Sens. 1
253-461-7
37321-15-6
Carc. 1A; STOT RE 1; Skin Sens. 1
253-390-1
37199-66-9
Skin Corr. 1B
253-242-6
36861-47-9
yes
253-178-9
36734-19-7
Carc. 2
253-057-0
36483-57-5
yes
253-037-1
36437-37-3
yes
252-984-8
36341-27-2
Carc. 1A; Acute Tox. 4
252-840-4
36026-88-7
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
252-626-0
35575-96-3
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 1; Skin Sens. 1

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