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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 srpnja 2024. Database contains 4821 unique substances/entries.
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201-865-9
88-89-1
Expl. 1.1; Acute Tox. 3
201-436-6
82-71-3
Expl. 1.1; Acute Tox. 4
428-390-1
86393-34-2
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
UK-51,060-01
412-390-3
86386-75-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
201-758-7
87-62-7
Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
TAA
407-850-5
89544-40-1
Acute Tox. 4; Eye Dam. 1
EPO
411-210-0
89544-48-9
Skin Irrit. 2; Skin Sens. 1
5-CHLOR-2-PENTANON-NEOPENTYLKETAL; 5-CHLORO-2-PENTANONE-NEOPENTYLKETAL; CHLORKETAL
417-650-1
88128-57-8
STOT RE 2
SIS 46 305
408-010-0
88558-41-2
Acute Tox. 4; Eye Dam. 1
201-289-8
80-54-6
Repr. 1B
yes
MCPSI
410-900-9
83056-32-0
Flam. Liq. 3; Muta. 2; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Resp. Sens. 1
JEFFCAT ZF-10; TEXACAT ZF-10
406-080-7
83016-70-0
Acute Tox. 4; Skin Corr. 1B
2-BUTYL-4-CHLORO-5-FORMYLIMIDAZOLE; BCFI
410-260-0
83857-96-9
Skin Sens. 1
201-864-3
88-88-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1
201-956-3
89-98-5
Skin Corr. 1B
212-836-5
873-32-5
Acute Tox. 4; Eye Irrit. 2
285-698-7
85135-77-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
279-452-8
80387-97-9
Repr. 1B; Skin Sens. 1
2-FLUOR-4-HYDROXYBENZONITRIL
422-810-7
82380-18-5
Acute Tox. 4; Eye Dam. 1
212-454-9
818-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
212-782-2
868-77-9
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
212-513-9
823-40-5
Muta. 2; Acute Tox. 4; Skin Sens. 1
212-513-9
823-40-5
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
201-853-3
88-72-2
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 4
128719
401-460-9
82560-06-3
Acute Tox. 3; Eye Dam. 1
421-310-6
87691-88-1
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
UK-48,340
425-820-1
88150-42-9
Acute Tox. 3; STOT RE 2; Eye Dam. 1
212-658-8
838-88-0
Carc. 1B; Acute Tox. 4; Skin Sens. 1
yes
201-793-8
88-04-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
CORANOL
420-630-3
83926-73-2
Eye Dam. 1
438-670-5
87199-17-5
Skin Sens. 1
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
CDFP
410-090-7
89402-43-7
Flam. Liq. 3; Acute Tox. 4
ARANCIO DISPERSO 149; C.I. DISPERSE ORANGE 149; DISPERS ORANGE 149; DISPERSE ORANGE 149; ORANGE DISPERSE 149; TERASIL GOLDGELB 2RS
400-340-3
85136-74-9
Carc. 1B
FLEXSORB-SE
400-390-6
87787-67-5
Skin Corr. 1A; Acute Tox. 4
FLUORCHINOLONCARBONSÄURE
405-050-0
86393-33-1
Acute Tox. 4
201-281-4
80-47-7
Org. Perox. D; Skin Corr. 1B; Acute Tox. 4
287-476-5
85535-84-8
Carc. 2
yes
281-985-6
84082-38-2
yes
283-930-1
84776-06-7
yes
287-504-6
85536-22-7
yes
287-477-0
85535-85-9
Lact.
yes
283-931-7
84776-07-8
yes
285-195-2
85049-26-9
yes
212-634-7
834-12-8
Acute Tox. 4
201-549-0
84-65-1
Carc. 1B
201-706-3
86-88-4
Acute Tox. 2; Carc. 2
201-676-1
86-50-0
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
620-403-0
8003-05-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
201-622-7
85-68-7
Repr. 1B
yes

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