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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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620-379-1
3254-63-5
Acute Tox. 1; Acute Tox. 2
254-408-0
39300-45-3
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
222-883-3
3648-18-8
Repr. 1B; STOT RE 1
223-292-3
3811-49-2
Acute Tox. 3; STOT SE 1
251-084-2
32534-81-9
STOT RE 2; Lact.
251-087-9
32536-52-0
Repr. 1B
222-098-6
3347-22-6
Acute Tox. 4
206-354-4
330-54-1
Carc. 2; Acute Tox. 4; STOT RE 2
250-778-2
31717-87-0
Repr. 2; STOT RE 2; Skin Corr. 1C; Skin Sens. 1A
253-704-7
37894-46-5
Repr. 1B; Acute Tox. 4; STOT RE 2
250-010-6
30043-49-3
Skin Sens. 1
3-NITROBENZYLIDENETHYLESTER
404-490-0
39562-16-8
Eye Dam. 1; Skin Sens. 1
253-855-9
38260-54-7
Acute Tox. 4
223-188-8
3766-81-2
Acute Tox. 4
254-485-0
39515-41-8
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
253-703-1
37893-02-0
Eye Irrit. 2
254-320-2
39148-24-8
Eye Dam. 1
223-404-0
3878-19-1
Carc. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
206-803-4
376-06-7
yes
206-114-9
302-01-2
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
252-615-0
35554-44-0
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Dam. 1
223-375-4
3861-47-0
Repr. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
253-178-9
36734-19-7
Carc. 2
250-610-8
31394-54-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
609-346-2
37205-87-1
yes
251-835-4
34123-59-6
Carc. 2; STOT RE 2
-
36614-38-7
Acute Tox. 3
206-104-4
301-04-2
Repr. 1A; STOT RE 2
yes
206-356-5
330-55-2
Repr. 1B; Carc. 2; Acute Tox. 4; STOT RE 2
BLACK UL 1253
417-280-9
30785-74-1
Eye Dam. 1
221-106-5
3006-10-8
Skin Corr. 1; Eye Dam. 1
445-990-9
376588-17-9
Skin Sens. 1
2-NITROBENZYLIDENE METHYL ESTER; BAY O 2787
400-650-9
39562-27-1
Skin Sens. 1
BM
405-270-7
39562-17-9
Skin Sens. 1
443-120-2
393509-79-0
Eye Dam. 1
250-366-2
30864-28-9
Acute Tox. 4; Skin Sens. 1
METHFAT
420-670-1
37443-42-8
Eye Dam. 1
206-249-3
315-18-4
Acute Tox. 2; Acute Tox. 4
206-742-3
371-86-8
STOT SE 1
206-098-3
300-76-5
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
223-463-2
3906-55-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
254-642-3
39819-65-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
222-068-2
3333-67-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
206-761-7
373-02-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
222-101-0
3349-06-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
252-840-4
36026-88-7
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
250-788-7
31748-25-1
Carc. 1A; STOT RE 1; Skin Sens. 1
222-102-6
3349-08-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
206-400-3
335-76-2
Carc. 2; Repr. 1B; Lact.
yes
221-817-0
3244-90-4
Acute Tox. 4

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