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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 lipnja 2024. Database contains 4821 unique substances/entries.
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231-765-0
7722-84-1
Ox. Liq. 1; Acute Tox. 4; Skin Corr. 1A
2-BUTANEDIOIC ACID, MONOAMIDE WITH N-(9-OCTADECENYL)-3-AMINO
402-970-4
148292-42-6
Skin Sens. 1
231-977-3
7783-06-4
Flam. Gas 1; Press. Gas; Acute Tox. 2
SICORIN E 10197
403-750-0
113036-91-2
Acute Tox. 4
423-310-1
61420-92-6
Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
641-410-5
130066-44-3
Skin Sens. 1A
232-259-2
7803-49-8
Unst. Expl.; Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
232-259-2
7803-49-8
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
258-872-5
53933-48-5
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
242-818-2
19098-16-9
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
244-077-0
20845-01-6
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
226-798-2
5470-11-1
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
233-154-4
10046-00-1
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
236-691-2
13465-08-2
Expl. 1.1; Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
DP-3337
405-710-8
23783-26-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
-
-
P Parasites
-
-
P Parasites
233-000-6
10004-44-1
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
200-090-3
51-34-3
Acute Tox. 2; Acute Tox. 1
202-933-0
101-31-5
Acute Tox. 2
-
-
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.
252-615-0
35554-44-0
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Dam. 1
261-351-5
58594-72-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
261-351-5
58594-72-2
Acute Tox. 4; Skin Sens. 1
601-305-7
114311-32-9
Repr. 2
617-219-8
81334-34-1
Eye Irrit. 2
428-040-8
138261-41-3
Acute Tox. 3
431-510-5
18087-70-2
Acute Tox. 4; Eye Irrit. 2
206-019-2
288-32-4
Repr. 1B; Acute Tox. 4; Skin Corr. 1C
428-790-6
72963-72-5
Carc. 2; Acute Tox. 4; STOT SE 2
244-959-5
22398-80-7
Carc. 1B; Repr. 2; STOT RE 1
605-683-4
173584-44-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 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.
-
-
Acute Tox. 2; Acute Tox. 1; STOT RE 2
231-442-4
7553-56-2
Acute Tox. 4
200-590-1
64-69-7
Acute Tox. 3; Skin Corr. 1A
-
696-33-3
Expl.
216-881-1
1689-83-4
Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
223-375-4
3861-47-0
Repr. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
603-038-1
125225-28-7
Repr. 1B; Acute Tox. 4; STOT RE 2
-
115937-89-8
Repr. 1B; Acute Tox. 4; STOT RE 2
-
115850-69-6
Repr. 1B; Acute Tox. 4; STOT RE 2
247-449-0
26087-47-8
Acute Tox. 4
253-178-9
36734-19-7
Carc. 2
604-209-3
140923-17-7
Carc. 2
-
5827-05-4
Acute Tox. 1; Acute Tox. 3
231-753-5
7720-78-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
616-510-7
7782-63-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
JOF 2822 5F; JOF 2822 5FL; JOF 4443
420-960-8
77214-82-5
Eye Dam. 1
255-863-8
42509-80-8
Acute Tox. 2; Acute Tox. 3; STOT RE 2; Skin Sens. 1
208-746-0
540-42-1
Flam. Liq. 3
206-045-4
297-78-9
Acute Tox. 1; Acute Tox. 2
200-857-2
75-28-5
Flam. Gas 1; Press. Gas
200-857-2
75-28-5
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
-
51337-71-4
Acute Tox. 4
IVAX
401-920-9
100181-71-3
Skin Irrit. 2; Skin Sens. 1
203-745-1
110-19-0
Flam. Liq. 2
203-417-8
106-63-8
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
ISOBUTYLVINYL ACETATE; IVA
401-170-2
24342-03-8
Flam. Liq. 3
208-818-1
542-55-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
202-613-0
97-86-9
Flam. Liq. 3; STOT SE 3; Skin Irrit. 2; Skin Sens. 1B
208-819-7
542-56-3
Flam. Liq. 2; Carc. 1B; Muta. 2; Acute Tox. 4
ZOLDINE RD-4
419-850-2
148348-13-4
Skin Corr. 1B
ALKYLSILANE TZ 01748; DYNASYLAN 9405; EURENOR(R) 5020; PSX 5305
402-580-4
111439-76-0
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
201-195-7
79-31-2
Acute Tox. 4
201-194-1
79-30-1
Flam. Liq. 2; Skin Corr. 1A
207-366-2
465-73-6
Acute Tox. 2; Acute Tox. 1
202-590-7
97-54-1
Skin Sens. 1A
246-814-1
25311-71-1
Acute Tox. 3
250-610-8
31394-54-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
247-861-0
26635-64-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
249-707-8
29590-42-9
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-142-8
78-78-4
Flam. Liq. 1; Asp. Tox. 1; STOT SE 3
204-662-3
123-92-2
Flam. Liq. 3
203-769-2
110-45-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-322-1
105-68-0
Flam. Liq. 3
201-143-3
78-79-5
Flam. Liq. 1; Carc. 1B; Muta. 2
220-114-6
2631-40-5
Acute Tox. 4
203-561-1
108-21-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-301-7
105-48-6
Flam. Liq. 3; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
210-901-2
625-55-8
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
211-300-8
637-78-5
Flam. Liq. 2
417-970-1
1379932-74-7
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Dam. 1
251-835-4
34123-59-6
Carc. 2; STOT RE 2
431-540-9
170573-32-7
Skin Irrit. 2
-
36614-38-7
Acute Tox. 3
604-222-4
141112-29-0
Repr. 2
242-624-8
18854-01-8
Acute Tox. 3
-
-
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.
-
-
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.
620-410-9
4234-79-1
Acute Tox. 3; Acute Tox. 4
A complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized thermal cracker distillate. It consists predominantly of hydrocarbons predominantly in the range of C8 to C16 and boiling in the range of approximately 120°C to 283°C (284°F to 541°F).
285-507-7
85116-55-8
Asp. Tox. 1
A complex combination of hydrocarbons obtained from a petroleum stock by treating with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 150°C to 290°C (302°F to 554°F).
265-184-9
64742-81-0
Asp. Tox. 1
A complex combination of hydrocarbons obtained from the distillation of petroleum and subsequent hydrotreatment. It consists predominantly of alkanes, cycloalkanes and alkylbenzenes having carbon numbers predominantly in the range of C12 through C16 and boiling in the range of approximately 230°C to 270°C (446°F to 518°F).
309-944-0
101631-19-0
Asp. Tox. 1
307-033-2
97488-94-3
Asp. Tox. 1
A complex combination of hydrocarbons obtained from a petroleum stock by solvent refining and sweetening and boiling in the range of approximately 150°C to 260°C (302°F to 500°F).
295-416-4
92045-36-8
Asp. Tox. 1
A complex combination of hydrocarbons obtained as a wide cut hydrocarbon fuel cut from atmospheric distillation and boiling in the range of approximately 70°C to 220°C (158°F to 428°F).
295-418-5
92045-37-9
Asp. Tox. 1
A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of 130°C to 290°C (266°F to 554°F).
294-799-5
91770-15-9
Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 150°C to 290°C (320°F to 554°F).
232-366-4
8008-20-6
Asp. Tox. 1
265-667-4
65277-42-1
Repr. 1B; Acute Tox. 3; STOT RE 2

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