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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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255-349-3
41394-05-2
Acute Tox. 4
7-ETHYLTRYPTOPHOL
431-020-1
41340-36-7
Acute Tox. 4; STOT RE 2
IN-4; INDENE IN-4
405-410-7
41201-60-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
255-255-2
41198-08-7
Acute Tox. 4
123U83; DDFU
415-360-8
41107-56-6
Muta. 2
255-209-1
41083-11-8
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
223-874-7
4104-14-7
Acute Tox. 1; Acute Tox. 2
223-861-6
4098-71-9
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
620-422-4
4097-36-3
Acute Tox. 3
206-991-8
409-21-2
Carc. 1B
443-840-7
4084-38-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
223-810-8
4083-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
223-791-6
4074-88-8
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
CLETOPROPAMINHYDROCHLORID
429-740-6
40722-80-3
Carc. 1B; Muta. 1B; STOT RE 2; Skin Sens. 1
223-775-9
4067-16-7
Skin Corr. 1B; Skin Sens. 1
BICH-3 STUFE 3
406-810-4
40649-36-3
Skin Irrit. 2
PARADISAMIDE
446-190-2
406488-30-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
430-250-1
406-58-6
Flam. Liq. 2
254-938-2
40487-42-1
Skin Sens. 1
223-714-6
4032-26-2
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
254-875-0
40292-82-8
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
429-520-1
4023-02-3
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
HYPO-LEM
403-620-3
40188-41-8
Skin Irrit. 2; Skin Sens. 1
642-974-5
400882-07-7
Carc. 2; Skin Sens. 1A
FAP
402-230-0
399-95-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
254-642-3
39819-65-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
254-637-6
39807-15-3
Repr. 2; STOT RE 2
2-NITROBENZYLIDENE METHYL ESTER; BAY O 2787
400-650-9
39562-27-1
Skin Sens. 1
BM
405-270-7
39562-17-9
Skin Sens. 1
3-NITROBENZYLIDENETHYLESTER
404-490-0
39562-16-8
Eye Dam. 1; Skin Sens. 1
254-485-0
39515-41-8
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
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Thrombin EC / List no: 232-648-7 | CAS no: 9002-04-4
Myxobacteralphalyticproteinase EC / List no: - | CAS no: 12585-31-8
Proteinase, Myxobacter α-lytic EC / List no: 253-448-6 | CAS no: 37288-76-9
Proteinase, Bacillus neutral EC / List no: 278-547-1 | CAS no: 76774-43-1
Proteinase, serine (Tritirachium album) EC / List no: 686-165-5 | CAS no: 102925-54-2
Proteinase, Myxobacter AL-1, II EC / List no: 276-716-4 | CAS no: 72561-05-8
Proteinase, Bacillus subtilis metallo- EC / List no: 232-991-2 | CAS no: 9080-56-2
Aspergillin M EC / List no: - | CAS no: 42615-60-1
Proteinase, bacterial E 30 serine EC / List no: - | CAS no: 39369-34-1
Proteinase, microbial acid EC / List no: 256-862-5 | CAS no: 50936-52-2
Proteinase, rhizopus acid EC / List no: 812-486-9 | CAS no: 9074-09-3
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Proteinase, Aspergillus alkaline EC / List no: 232-977-6 | CAS no: 9074-07-1
Proteinase, Aspergillus melleus, semialkaline EC / List no: - | CAS no: 76106-83-7
Proteinase, Tritirachium album serine EC / List no: 254-457-8 | CAS no: 39450-01-6
Proteinase, Agkistrodon serine EC / List no: 232-933-6 | CAS no: 9046-56-4
Proteinase, Serratia extracellular EC / List no: 253-457-5 | CAS no: 37312-62-2
Proteinase, Streptomyces griseus EC / List no: 232-909-5 | CAS no: 9036-06-0
Proteinase, oryzin EC / List no: 232-992-8 | CAS no: 9081-30-5
Proteinase, Endothia aspartic EC / List no: 253-395-9 | CAS no: 37205-60-0
Proteinase, Mucor aspartic EC / List no: 232-975-5 | CAS no: 9073-79-4
Proteinase, Aspergillus neutral EC / List no: 278-588-5 | CAS no: 77000-13-6
Proteinase, Bacillus alcalophilus serine EC / List no: 306-090-0 | CAS no: 95979-76-3
Proteinase, Bacillus polymyxa neutral EC / List no: 255-914-4 | CAS no: 42613-33-2
Proteinase, Staphylococcus aureus serine EC / List no: 259-611-8 | CAS no: 55354-32-0
Proteinase, Aspergillus oryzae neutral EC / List no: 232-990-7 | CAS no: 9080-55-1
Proteinase, Bacillus subtilis EC / List no: 257-520-8 | CAS no: 51931-23-8
Proteinase, Bacillus subtilis serine EC / List no: 266-557-9 | CAS no: 67051-83-6
Bacillus megaterium protease fermentation product EC / List no: - | CAS no: 68909-17-1
Proteinase, Bothrops atrox serine EC / List no: 232-918-4 | CAS no: 9039-61-6
Proteinase, submandibular gland serine, A EC / List no: 279-893-6 | CAS no: 82047-85-6
Proteinase, Bacillus subtilis, sutilain EC / List no: 235-390-3 | CAS no: 12211-28-8
Proteinase, microbial neutral EC / List no: 232-966-6 | CAS no: 9068-59-1
Proteinase, aspartic EC / List no: 278-856-1 | CAS no: 78169-47-8
Proteinase, pancreatic EC / List no: 232-626-7 | CAS no: 9001-72-3
Proteinase, Aspergillus niger neutral EC / List no: 254-422-7 | CAS no: 39346-39-9
Proteinase, Bacillus alkaline EC / List no: 232-972-9 | CAS no: 9073-77-2
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Proteinase, Aspergillus parasiticus neutral EC / List no: 254-418-5 | CAS no: 39335-09-6
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Proteinase, Bacillus licheniformis serine EC / List no: 279-361-3 | CAS no: 79986-26-8
Proteinase, Aspergillus acid EC / List no: 232-796-2 | CAS no: 9025-49-4
Proteinase, microbial alkaline EC / List no: 256-863-0 | CAS no: 50936-53-3
Proteinase, serine EC / List no: 253-431-3 | CAS no: 37259-58-8
934-013-6
39450-01-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
444-480-3
393517-29-8
Skin Irrit. 2
443-120-2
393509-79-0
Eye Dam. 1
254-408-0
39300-45-3
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
223-498-3
3926-62-3
Acute Tox. 3; Skin Irrit. 2
254-346-4
39196-18-4
Acute Tox. 1; Acute Tox. 2
254-323-9
39156-41-7
Carc. 1B; Muta. 2; Acute Tox. 4
254-320-2
39148-24-8
Eye Dam. 1
223-463-2
3906-55-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
223-404-0
3878-19-1
Carc. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
223-393-2
3871-99-6
yes
223-383-8
3864-99-1
yes
2,3,4-TRIFLUORANILIN
407-170-9
3862-73-5
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
223-375-4
3861-47-0
Repr. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
A-87440.0; A-87440.00
414-780-9
38585-74-9
Eye Dam. 1
3-CHLORO-2,4-DIFLUORONITROBENZENE
411-980-8
3847-58-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
223-346-6
3846-71-7
yes
NA-2-ETHYLHEXANOLAT
406-150-7
38411-13-1
Flam. Sol. 1; Skin Corr. 1B
-
3830-45-3
Carc. 2; Repr. 1B; Lact.
yes

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