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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 srpnja 2024. Database contains 4821 unique substances/entries.
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700-242-3
62037-80-3
yes
604-314-4
142844-00-6
yes
603-801-9
134237-50-6
yes
263-004-3
61788-76-9
yes
272-924-4
68920-70-7
yes
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
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
-
-
yes
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
257-175-3
51404-69-4
yes
273-688-5
69011-06-9
yes
219-943-6
2580-56-5
yes
204-419-1
120-71-8
Carc. 1B; Acute Tox. 4
yes
204-327-1
119-47-1
Repr. 1B
yes
-
-
yes
-
-
yes
-
-
yes
621-345-9
2315-67-5
yes
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes
202-591-2
97-56-3
Carc. 1B; Skin Sens. 1
yes
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
-
-
yes
-
-
yes
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
202-453-1
95-80-7
yes
608-055-8
27147-75-7;27459-10-5
yes
608-055-8
27147-75-7;27459-10-5
yes
-
-
yes
217-862-0
1987-50-4
yes
200-453-6
60-09-3
Carc. 1B
yes
635-696-0
186825-39-8
yes
635-391-2
142731-63-3
yes
635-389-1
186825-36-5
yes
272-233-8
68784-25-8
yes
-
-
yes
635-388-6
521947-27-3
yes
257-907-1
52427-13-1
yes
205-426-2
140-66-9
Skin Irrit. 2; Eye Dam. 1
yes
-
-
yes
621-341-7
2315-61-9
yes
AP-5
401-720-1
6807-17-6
Repr. 1B; Eye Irrit. 2
yes
-
-
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes

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