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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 lipnja 2024. Database contains 4821 unique substances/entries.
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222-101-0
3349-06-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
235-008-5
12054-48-7
Carc. 1A; Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
236-666-6
13462-90-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
236-068-5
13138-45-9
Ox. Sol. 2; Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
234-823-3
12035-36-8
Carc. 1A; STOT RE 1; Skin Sens. 1
237-124-1
13637-71-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
237-563-9
13842-46-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
235-379-3
12201-89-7
Carc. 1A; STOT RE 1; Skin Sens. 1
237-205-1
13689-92-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
257-970-5
52502-12-2
Carc. 1A; STOT RE 1; Skin Sens. 1
247-430-7
26043-11-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-278-2
14332-34-4
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
234-348-1
11113-74-9
Carc. 1A; Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
248-585-3
27637-46-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Product of blowing smelted nickel ore in a converter to lower the iron content.
273-749-6
69012-50-6
Carc. 1A; STOT RE 1; Skin Sens. 1
215-215-7
1313-99-1
Carc. 1A; STOT RE 1; Skin Sens. 1
208-933-7
547-67-1
Carc. 1A; STOT RE 1; Skin Sens. 1
234-323-5
11099-02-8
Carc. 1A; STOT RE 1; Skin Sens. 1
252-840-4
36026-88-7
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-125-2
15060-62-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
215-216-2
1314-05-2
Carc. 1A; STOT RE 1; Skin Sens. 1
250-788-7
31748-25-1
Carc. 1A; STOT RE 1; Skin Sens. 1
232-104-9
7786-81-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
234-349-7
11113-75-0
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
235-260-6
12142-88-0
Carc. 1A; STOT RE 1; Skin Sens. 1
239-974-9
15852-21-8
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-967-0
15851-52-2
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
234-824-9
12035-38-0
Carc. 1A; STOT RE 1; Skin Sens. 1
235-752-0
12653-76-8
Carc. 1A; STOT RE 1; Skin Sens. 1
234-825-4
12035-39-1
Carc. 1A; STOT RE 1; Skin Sens. 1
239-876-6
15780-33-3
Carc. 1A; STOT RE 1; Skin Sens. 1
238-032-4
14177-51-6
Carc. 1A; STOT RE 1; Skin Sens. 1
274-755-1
70692-93-2
Carc. 1A; STOT RE 1; Skin Sens. 1
242-533-3
18721-51-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-468-1
85508-43-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
249-555-2
29317-63-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-469-7
85508-44-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
225-656-7
4995-91-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
237-138-8
13654-40-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 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
233-263-7
10101-96-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
244-578-4
21784-78-1
Carc. 1A; STOT RE 1; Skin Sens. 1
218-744-1
2223-95-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
231-827-7
7757-95-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
240-235-8
16083-14-0
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
231-111-4
7440-02-0
Carc. 2; STOT RE 1; Skin Sens. 1
231-111-4
7440-02-0
Carc. 2; STOT RE 1; Skin Sens. 1
200-193-3
54-11-5
Acute Tox. 2
217-682-2
1929-82-4
Acute Tox. 4
231-714-2
7697-37-2
Ox. Liq. 3; Acute Tox. 3; Skin Corr. 1A
238-076-4
14216-75-2
Ox. Sol. 2; Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
202-716-0
98-95-3
Carc. 2; Repr. 1B; Acute Tox. 3; STOT RE 1
yes
201-188-9
79-24-3
Flam. Liq. 3; Acute Tox. 4
217-406-0
1836-75-5
Carc. 1B; Repr. 1B; Acute Tox. 4
233-272-6
10102-44-0
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1B
200-876-6
75-52-5
Flam. Liq. 3; Acute Tox. 4
210-698-0
621-64-7
Carc. 1B; Acute Tox. 4
206-400-3
335-76-2
Carc. 2; Repr. 1B; Lact.
yes
203-931-2
112-05-0
Skin Irrit. 2; Eye Irrit. 2
246-672-0
25154-52-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
213-589-6
991-42-4
Acute Tox. 4
221-817-0
3244-90-4
Acute Tox. 4
227-534-9
5873-54-1
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
202-423-8
95-48-7
Acute Tox. 3; Skin Corr. 1B
218-276-8
2104-64-5
Acute Tox. 1; Acute Tox. 2
201-855-4
88-74-4
Acute Tox. 3; STOT RE 2
202-430-6
95-54-5
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
210-418-7
615-28-1
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
202-429-0
95-53-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2
yes
202-422-2
95-47-6
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
204-695-3
124-30-1
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
209-136-7
556-67-2
Repr. 2
yes
203-892-1
111-65-9
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
204-677-5
124-07-2
Skin Corr. 1C
247-761-7
26530-20-1
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
213-853-0
1034-01-1
Acute Tox. 4; Skin Sens. 1
An inorganic pigment that is the reaction product of high temperature calcination in which nickel (II) oxide and silicon oxide in varying amounts are homogeneously and ionically interdiffused to form a crystalline matrix of olivine. Its composition may include any one or a combination of the modifiers alkali or alkaline earth halides.
271-112-7
68515-84-4
Carc. 1A; STOT RE 1; Skin Sens. 1
214-197-8
1113-02-6
Acute Tox. 3; Acute Tox. 4
215-235-6
1314-41-6
yes
237-560-2
13840-56-7
Repr. 1B
yes
244-058-7
20816-12-0
Acute Tox. 2; Acute Tox. 1; Skin Corr. 1B
211-139-3
630-60-4
Acute Tox. 3; STOT RE 2
254-637-6
39807-15-3
Repr. 2; STOT RE 2
205-634-3
144-62-7
Acute Tox. 4
202-464-1
95-92-1
Acute Tox. 4; Eye Irrit. 2
243-867-2
20543-06-0
Carc. 1A; STOT RE 1; Skin Sens. 1
207-306-5
460-19-5
Press. Gas; Flam. Gas 1; Acute Tox. 3
245-445-3
23135-22-0
Acute Tox. 2; Acute Tox. 4
271-846-8
68609-97-2
Skin Irrit. 2; Skin Sens. 1
226-066-2
5259-88-1
Acute Tox. 4
206-110-7
301-12-2
Acute Tox. 3
203-430-9
106-75-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
211-745-8
693-21-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
211-745-8
693-21-0
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
219-679-1
2497-07-6
Acute Tox. 2; Acute Tox. 3
231-956-9
7782-44-7
Ox. Gas 1; Press. Gas
250-339-5
30784-30-6
yes
201-280-9
80-46-6
yes
241-427-4
17404-66-9
yes
203-254-2
104-94-9
Acute Tox. 2; Acute Tox. 1; STOT RE 2

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