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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 07 listopada 2024. Database contains 4821 unique substances/entries.
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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
200-662-2
67-64-1
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
200-835-2
75-05-8
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2
202-708-7
98-86-2
Acute Tox. 4; Eye Irrit. 2
200-865-6
75-36-5
Flam. Liq. 2; Skin Corr. 1B
200-816-9
74-86-2
Flam. Gas 1; Press. Gas
CGA 245704 TECH.
420-050-0
135158-54-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
256-634-5
50594-66-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
277-704-1
74070-46-5
Carc. 2; Skin Sens. 1A
206-121-7
302-27-2
Acute Tox. 2
203-453-4
107-02-8
Flam. Liq. 2; Acute Tox. 1; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
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
419-560-6
4369-14-6
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
247-118-0
25584-83-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
201-177-9
79-10-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
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
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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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.
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yes
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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.
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B Bacteria and similar species
204-673-3
124-04-9
Eye Irrit. 2
240-110-8
15972-60-8
Carc. 2; Acute Tox. 4; Skin Sens. 1
204-123-2
116-06-3
Acute Tox. 2; Acute Tox. 3
206-215-8
309-00-2
Carc. 2; Acute Tox. 3; STOT RE 1
240-896-2
16871-90-2
Acute Tox. 3
240-934-8
16893-85-9
Acute Tox. 3
240-968-3
16919-19-0
Acute Tox. 3
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-
Acute Tox. 4
270-651-5
68475-57-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
292-456-4
90622-55-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
287-476-5
85535-84-8
Carc. 2
yes
281-985-6
84082-38-2
yes
307-451-5
97659-46-6
yes
283-930-1
84776-06-7
yes
287-504-6
85536-22-7
yes
292-454-3
90622-53-0
Carc. 1B
701-376-5
1372804-76-6
yes
287-477-0
85535-85-9
Lact.
yes
283-931-7
84776-07-8
yes
285-195-2
85049-26-9
yes
270-652-0
68475-58-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-653-6
68475-59-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-654-1
68475-60-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
272-924-4
68920-70-7
yes

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