Item

Description

Time

Sample Requirement*

1

Cytotoxicity Test (ISO 10993-5)

10 days

4 g (irregular shape);
60 cm2 If > 0.5mm thick
120 cm2 If < 0.5mm thick

2

Skin irritation Test
(ISO 10993-10)

14 days

8 g (irregular shape);
120 cm2 If > 0.5mm thick
240 cm2 If < 0.5mm thick

3

Intracutaneous Irritation Test
(ISO 10993-10)

14 days

8 g (irregular shape);
120 cm2 If > 0.5mm thick
240 cm2 If < 0.5mm thick

4

Skin sensitization Test [Maximization Test]
(ISO 10993-10)

2 months

24 g (irregular shape);
360 cm2 If > 0.5mm thick
720 cm2 If < 0.5mm thick

5

Skin sensitization Test [Closed-patch Test]

(ISO 10993-10)

2.5 months

40 g (irregular shape);
120 pieces of 2.5 × 2.5cm patches each

6

Systemic Inject Test/(Acute Systemic Toxicity )
(ASTM F750, ISO10993-11)

14 days

8 g (irregular shape);
120 cm2 If > 0.5mm thick
240 cm2 If < 0.5mm thick

7

Pyrogen Test
(USP, ISO 10993-11)

14 days

24 g (irregular shape);
360 cm2 If > 0.5mm thick
720 cm2 If < 0.5mm thick

8

Hemolysis Test
(ASTM F756, ISO 10993-4)

14 days

8 g (irregular shape);
120 cm2 If > 0.5mm thick
240 cm2 If < 0.5mm thick

9

Ocular Irritation Test-2 Extracts
(ISO 10993-10)

14 days

8 g (irregular shape);
120 cm2 If > 0.5mm thick
240 cm2 If < 0.5mm thick

10

Implantation Test
(ISO 10993-6)

Subcutaneous

Please
inquire to
the lab

Please inquire to the lab

Muscle

Please
inquire to
the lab

Please inquire to the lab

Bone

Please
inquire to
the lab

Please inquire to the lab

11

Genotoxicity Test- Bacterial Reverse Mutation
(OECD Guidelines 471 ,ISO10993-3)

6 weeks

8 g (irregular shape);
120 cm2 If > 0.5mm thick
240 cm2 If < 0.5mm thick

Genotoxicity Test-Chromosomal Aberration
(OECD Guidelines 473 ,ISO10993-3 )

 6 weeks

4 g (irregular shape);
60 cm2 If > 0.5mm thick
120 cm2 If < 0.5mm thick

Genotoxicity Test- Mouse Lymphoma Mutation Test
(OECD Guidelines 476 ,ISO10993-3)

6 weeks

8 g (irregular shape);
120 cm2 If > 0.5mm thick
240 cm2 If < 0.5mm thick

Genotoxicity Test- Mice micronucleus Test
(OECD Guidelines 474 ,ISO10993-3)

6 weeks

8 g (irregular shape);
120 cm2 If > 0.5mm thick
240 cm2 If < 0.5mm thick

12

Acute Oral Toxicity Test

Please
inquire to
the lab

Please inquire to the lab

13

Bacterial Endotoxins Test-LAL Test
(USP)

14 days

Please inquire to the lab

14

Subacute /Subchronic Toxicity Test
(OECD, ISO10993-11)

Please
inquire to
the lab

Please inquire to the lab

15

Chronic Toxicity Test
(OECD, ISO10993-11)

Please
inquire to
the lab

Please inquire to the lab

16

USP Class I~VI
(USP)

Please
inquire to
the lab
Please inquire to the lab

Note:
*:When the surface area can not be determined due to configuration of the sample, a mass/volume of extracting fluid shall be used.

Cytotoxicity Test
This test applies cell culture to test the lysis of cells (cell death), the inhibition of cell growth, and other effects on cells caused by medical devices, materials and/or their extracts. Cytotoxicity test is described in ISO 10993-5.

Skin Irritation Test
The purpose of this study is to estimate the potential of the test article using single exposure to produce dermal irritation in the rabbits. Skin irritation test is described in ISO 10993-10.

Intracutaneous Irritation Test
Intracutaneous irritation test is used to assess the localized reaction of tissue to medical device extracts. This test is applicable where the determination of irritation by dermal or mucosal tests is inappropriate (e.g. where medical devices are implanted or have blood contact). Intracutaneous irritation test is described in ISO 10993-10.

Sensitization Test
This test is used to estimate the potential for contact sensitization by cmedical devices, materials and/or their extracts, using an appropriate animal model. This test is important because exposure or contact to even minute amounts of potential leachables can result in allergic or sensitization reactions. Sensitization test is described in ISO 10993-10.

Systemic Toxicity (Acute Toxicity) Test
Acute systemic toxicity test is used where contact allows potential absorption of toxic leachables and degradation products, to estimate the potential harmful effects of either single or multiple exposures, during a period of less than 24h, to medical devices, materials and/or their extracts in an animal model. Systemic toxicity test is described in ISO 10993-11.

Pyrogen Test
Pyrogen test is included to detect material-mediated pyrogenic reactions of extracts of medical devices or materials. Pyrogen test is described in USP<151>

Hemolysis Test
Hemolysis test is to determine the degree of red blood cell lysis and the release of hemoglobin caused by medical devices, materials and/or their extracts in vitro. Hemolysis is described in ASTM F756 and ISO 10993-4.

Ocular Irritation Test
An assessment is made of the potential of the medical devices, materials and/or their extracts under test to produce ocular irritation.

Implantation Test
Implantation tests are used to assess the local pathological effects on living tissue, at both the gross level and microscopic level, of a sample of a material or final product that is surgically implanted or placed in an implant site or tissue appropriate to the intended application (e.g. special dental usage tests). These tests are appropriate for the route and duration of contact. If feasible, implantation test protocols may be expanded to evaluate both local and systemic effects to meet acute, subacute, subchronic, and chronic toxicity test requirements. Implantation tests are described in ISO 10993-6.

Genotoxicity Test
These tests use mammalian or non- mammalian cell culture or other techniques to determine gene mutations, changes in chromosome structure and number, and other DNA or gene toxicities caused by medical devices, materials and/or their extracts. Genotoxicity tests are described in ISO 10993-3.

Acute Oral Toxicity Test
The purpose of this test is to evaluate the acute toxicity of test article in mice via oral administration.

Subacute and Subchronic Toxicity Tests
Subacute and subchronic toxicity tests are carried out to determine the effects of either single or multiple exposures or contact to medical devices, materials and/or their extracts for a period not less than 24 h to a period not greater than 10 % of the total life-span of the test animal(e.g. up to 13 weeks in rats). These tests shall be appropriate for the route and duration of contact. Subacute and subchronic toxicity tests are described in 10993-11.

Chronic Toxicity Test
Chronic toxicity test is used to determine the effects of either single or multiple exposures to medical devices, materials and/or their extracts during a major period of the life-span of the test animal (e.g. usually 6 months in rats). These tests shall be appropriate for the route and duration of exposure or contact. Chronic toxicity test is described in ISO10993-11.

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