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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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.
Filter the list

-
919-76-6
Acute Tox. 4
212-634-7
834-12-8
Acute Tox. 4
604-314-4
142844-00-6
yes
209-090-8
555-31-7
Flam. Sol. 1
231-072-3
7429-90-5
Water-react. 2; Pyr. Sol. 1
231-072-3
7429-90-5
Water-react. 2; Flam. Sol. 1
244-088-0
20859-73-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
240-877-9
16853-85-3
Water-react. 1; Skin Corr. 1A
231-208-1
7446-70-0
Skin Corr. 1B
-
-
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
603-801-9
134237-50-6
yes
203-463-9
107-11-9
Flam. Liq. 2; Acute Tox. 3
202-473-0
96-05-9
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4
203-442-4
106-92-3
Flam. Liq. 3; Carc. 2; Muta. 2; Repr. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
203-470-7
107-18-6
Flam. Liq. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-270-7
93-71-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
435-650-8
-
Acute Tox. 4; Skin Corr. 1A
435-660-2
243662-67-1
Skin Irrit. 2; Skin Sens. 1
263-004-3
61788-76-9
yes
272-924-4
68920-70-7
yes
270-654-1
68475-60-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-653-6
68475-59-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-652-0
68475-58-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
285-195-2
85049-26-9
yes
283-931-7
84776-07-8
yes
287-477-0
85535-85-9
Lact.
yes
701-376-5
1372804-76-6
yes
292-454-3
90622-53-0
Carc. 1B
287-504-6
85536-22-7
yes
283-930-1
84776-06-7
yes
307-451-5
97659-46-6
yes
281-985-6
84082-38-2
yes
287-476-5
85535-84-8
Carc. 2
yes
292-456-4
90622-55-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-651-5
68475-57-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
-
-
Acute Tox. 4
240-968-3
16919-19-0
Acute Tox. 3
240-934-8
16893-85-9
Acute Tox. 3
240-896-2
16871-90-2
Acute Tox. 3
206-215-8
309-00-2
Carc. 2; Acute Tox. 3; STOT RE 1
204-123-2
116-06-3
Acute Tox. 2; Acute Tox. 3
240-110-8
15972-60-8
Carc. 2; Acute Tox. 4; Skin Sens. 1
204-673-3
124-04-9
Eye Irrit. 2
-
-
B Bacteria and similar species
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
-
-
yes
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
203-466-5
107-13-1
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
201-177-9
79-10-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
247-118-0
25584-83-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
419-560-6
4369-14-6
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
201-173-7
79-06-1
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
yes
203-453-4
107-02-8
Flam. Liq. 2; Acute Tox. 1; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
206-121-7
302-27-2
Acute Tox. 2
277-704-1
74070-46-5
Carc. 2; Skin Sens. 1A
256-634-5
50594-66-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
CGA 245704 TECH.
420-050-0
135158-54-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
200-816-9
74-86-2
Flam. Gas 1; Press. Gas
200-865-6
75-36-5
Flam. Liq. 2; Skin Corr. 1B
202-708-7
98-86-2
Acute Tox. 4; Eye Irrit. 2
200-835-2
75-05-8
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2
200-662-2
67-64-1
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
251-899-3
34256-82-1
Carc. 2; Repr. 2; Acute Tox. 4; STOT SE 3; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
203-564-8
108-24-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
257-175-3
51404-69-4
yes
200-580-7
64-19-7
Flam. Liq. 3; Skin Corr. 1A
603-921-1
135410-20-7
Acute Tox. 4
200-473-5
60-35-5
Carc. 2
200-836-8
75-07-0
Flam. Liq. 1; Carc. 1B; Muta. 2; Eye Irrit. 2; STOT SE 3
611-595-7
57960-19-7
Skin Sens. 1; STOT SE 1; STOT RE 2
250-241-2
30560-19-1
Acute Tox. 4
-
-
P Parasites
A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260°C to 290°C (500°F to 554°F).
309-851-5
101316-45-4
Carc. 1B
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
615-339-5
71751-41-2
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
CCA-VERSUCHSPRODUKT SN 4001
405-080-4
118725-24-9
Eye Dam. 1
265-748-4
65405-96-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
SQ 28,796
415-820-8
137590-32-0
Eye Dam. 1; Skin Sens. 1
273-688-5
69011-06-9
yes
425-520-9
197179-61-6
Eye Dam. 1
419-840-8
169104-71-6
Flam. Sol. 1; Skin Corr. 1B; Skin Sens. 1
235-715-9
12607-70-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
419-270-1
123599-82-6
Eye Irrit. 2
219-943-6
2580-56-5
yes
433-690-0
167678-46-8
Skin Corr. 1A; Skin Sens. 1
NITROGELB
410-700-1
27080-42-8
Skin Sens. 1
426-890-4
77341-67-4
Eye Dam. 1
247-711-4
26447-14-3
Muta. 2; Skin Irrit. 2; Skin Sens. 1
218-574-8
2186-24-5
Muta. 2; Skin Irrit. 2; Skin Sens. 1
218-575-3
2186-25-6
Muta. 2; Skin Irrit. 2; Skin Sens. 1
M1
422-060-0
137390-08-0
Acute Tox. 2
416-360-0
162221-28-5
Skin Sens. 1

Export search results to: