Cytotoxicity Test
ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
USP <87> Elution Test
1. Test Article Extraction: Cell culture medium
2. Test Cell Line: L929 cell line
3. Evaluation Items
1. Test Article Extraction: Cell culture medium
2. Test Cell Line: L929 cell line
3. Evaluation Items
(1) Quantitative Analysis: Cell viability is assessed at 24 hours after adding the test article extract using MTT assay
(2) Qualitative Analysis: Cell morphology is assessed using Neutral Red staining
(2) Qualitative Analysis: Cell morphology is assessed using Neutral Red staining
Skin Irritation Test
ISO 10993-23 Biological evaluation of medical devices — Part 23: Tests for irritation
1. Test Article Extraction: Two types of extracts (polar and non-polar)
2. Test Groups:
Test: Test article extract (polar), Test article extract (non-polar)
Control: Extraction solvent (polar), Extraction solvent (non-polar)
Control: Extraction solvent (polar), Extraction solvent (non-polar)
3. Test Animals: New Zealand White (NZW) Rabbits
4. Number of Animals: 6 animals
5. Route of Administration: Dermal patch contact
6. Dosing Frequency: Single application
7. Study Duration: Three days (excluding quarantine and acclimatization period)
8. Evaluation Items:
4. Number of Animals: 6 animals
5. Route of Administration: Dermal patch contact
6. Dosing Frequency: Single application
7. Study Duration: Three days (excluding quarantine and acclimatization period)
8. Evaluation Items:
(1) Daily clinical observations
(2) Irritation observation and scoring: Observation and scoring performed prior to dosing and at 1, 24, 48, and 72 hours post-dosing
Intracutaneous Irritation Test
ISO 10993-23 Biological evaluation of medical devices — Part 23: Tests for irritation
1. Test Article Extraction: Two types of extracts (polar and non-polar)
2. Test Groups:
2. Test Groups:
Test Group: Test article extract (polar), Test article extract (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
3. Test Animals: New Zealand White (NZW) Rabbits
4. Number of Animals: 3 animals
5. Route of Administration: Intradermal injection
6. Dosing Frequency: Single administration
7. Study Duration: Three days (excluding quarantine and acclimatization period)
8. Evaluation Items:
4. Number of Animals: 3 animals
5. Route of Administration: Intradermal injection
6. Dosing Frequency: Single administration
7. Study Duration: Three days (excluding quarantine and acclimatization period)
8. Evaluation Items:
(1) Daily clinical observations
(2) Irritation observation and scoring: Observation and scoring performed prior to dosing and at 24, 48, and 72 hours post-dosing
(2) Irritation observation and scoring: Observation and scoring performed prior to dosing and at 24, 48, and 72 hours post-dosing
Ocular Irritation Test
ISO 10993-23 Biological evaluation of medical devices — Part 23: Tests for irritation
1. Test Article Extraction: Two types of extracts (polar and non-polar)
2. Test Groups:
2. Test Groups:
Test Group: Test article extract (polar), Test article extract (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
3. Test Animals: New Zealand White (NZW) Rabbits
4. Number of Animals: 6 animals
5. Route of Administration: Instillation into the eye
6. Dosing Frequency: Single administration.
7. Study Duration: Three days (excluding quarantine and acclimatization period)
8. Evaluation Items:
4. Number of Animals: 6 animals
5. Route of Administration: Instillation into the eye
6. Dosing Frequency: Single administration.
7. Study Duration: Three days (excluding quarantine and acclimatization period)
8. Evaluation Items:
(1) Daily clinical observations
(2) Irritation observation and scoring: Observation and scoring performed prior to dosing and at 1, 24, 48, and 72 hours post-dosing
(2) Irritation observation and scoring: Observation and scoring performed prior to dosing and at 1, 24, 48, and 72 hours post-dosing
Oral Mucosa Irritation Test
ISO 10993-23 Biological evaluation of medical devices — Part 23: Tests for irritation
1. Test Article Extraction: Two types of extracts (polar and non-polar)
2. Test Groups:
2. Test Groups:
Test Group: Test article extract (polar), Test article extract (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
3. Test Animals: Syrian Hamsters
4. Number of Animals: 12 animals
5. Route of Administration: Oral mucosa contact
6. Dosing Frequency: Repeated contact four times
7. Study Duration: Two days (excluding quarantine and acclimatization period)
8. Evaluation Items:
4. Number of Animals: 12 animals
5. Route of Administration: Oral mucosa contact
6. Dosing Frequency: Repeated contact four times
7. Study Duration: Two days (excluding quarantine and acclimatization period)
8. Evaluation Items:
(1) Daily clinical observations
(2) Irritation observation and scoring: Observation and scoring performed prior to dosing and at 1, 2, 3, 4 hours (hourly contact) and 24 hours post- dosing
(3) Tissue sectioning of the application site
(4) Histopathological evaluation
(2) Irritation observation and scoring: Observation and scoring performed prior to dosing and at 1, 2, 3, 4 hours (hourly contact) and 24 hours post- dosing
(3) Tissue sectioning of the application site
(4) Histopathological evaluation
Vaginal Irritation Test
10993-23 Biological evaluation of medical devices — Part 23: Tests for irritation
1. Test Article Extraction: Two types of extracts (polar and non-polar)
2. Test Groups:
2. Test Groups:
Test Group: Test article extract (polar), Test article extract (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
3. Test Animals: New Zealand White (NZW) Rabbits
4. Number of Animals: 12 animals
5. Route of Administration: Vaginal mucosa contact
6. Dosing Frequency: Five applications (once daily for five days)
7. Study Duration: Six days (excluding quarantine and acclimatization period)
8. Evaluation Items:
4. Number of Animals: 12 animals
5. Route of Administration: Vaginal mucosa contact
6. Dosing Frequency: Five applications (once daily for five days)
7. Study Duration: Six days (excluding quarantine and acclimatization period)
8. Evaluation Items:
(1) Daily clinical observations
(2) Irritation observation and scoring: Observation and scoring performed prior to initial dosing, following each daily dosing, and at 24 hours after final dosing
(3) Tissue sectioning of the application site
(4) Histopathological evaluation
(2) Irritation observation and scoring: Observation and scoring performed prior to initial dosing, following each daily dosing, and at 24 hours after final dosing
(3) Tissue sectioning of the application site
(4) Histopathological evaluation
Penile Irritation Test
ISO 10993-23 Biological evaluation of medical devices — Part 23: Tests for irritation
1. Test Article Extraction: Two types of extracts (polar and non-polar)
2. Test Groups:
2. Test Groups:
Test Group: Test article extract (polar), Test article extract (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
3. Test Animals: New Zealand White (NZW) Rabbits
4. Number of Animals: 12 animals
5. Route of Administration: Penile contact
6. Dosing Frequency: Repeated contact four times
7. Study Duration: Three days (excluding quarantine and acclimatization period)
8. Evaluation Items:
4. Number of Animals: 12 animals
5. Route of Administration: Penile contact
6. Dosing Frequency: Repeated contact four times
7. Study Duration: Three days (excluding quarantine and acclimatization period)
8. Evaluation Items:
(1) Daily clinical observations
(2) Irritation observation and scoring: Observation and scoring performed prior to dosing and at 1, 24, and 48 hours after dosing
(3) Tissue sectioning of the application site
(4) Histopathological evaluation
(2) Irritation observation and scoring: Observation and scoring performed prior to dosing and at 1, 24, and 48 hours after dosing
(3) Tissue sectioning of the application site
(4) Histopathological evaluation
Rectal Irritation Test
ISO 10993-23 Biological evaluation of medical devices — Part 23: Tests for irritation
1. Test Article Extraction: Two types of extracts (polar and non-polar)
2. Test Groups:
2. Test Groups:
Test Group: Test article extract (polar), Test article extract (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
3. Test Animals: New Zealand White (NZW) Rabbits
4. Number of Animals: 12 animals
5. Route of Administration: Rectal mucosa contact
6. Dosing Frequency: Five applications (once daily for five days)
7. Study Duration: Six days (excluding quarantine and acclimatization period)
8. Evaluation Items:
4. Number of Animals: 12 animals
5. Route of Administration: Rectal mucosa contact
6. Dosing Frequency: Five applications (once daily for five days)
7. Study Duration: Six days (excluding quarantine and acclimatization period)
8. Evaluation Items:
(1) Daily clinical observations
(2) Irritation observation and scoring: Observation and scoring performed prior to initial dosing, following each daily dosing, and at 24 hours after final dosing
(3) Tissue sectioning of the application site
(4) Histopathological evaluation
(2) Irritation observation and scoring: Observation and scoring performed prior to initial dosing, following each daily dosing, and at 24 hours after final dosing
(3) Tissue sectioning of the application site
(4) Histopathological evaluation
Skin Sensitization Study (Guinea Pig Maximization Test)
ISO 10993-10 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
1. Test Article Extraction: Two types of extracts (polar and non-polar)
2. Test Groups:
2. Test Groups:
Test Group: Test article extract (polar), Test article extract (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
3. Test Animals: Guinea Pigs
4. Number of Animals: 30 animals
5. Route of Administration: Intradermal injection, Dermal patch application
6. Study Duration: Thirty days (excluding quarantine and acclimatization period)
7. Evaluation Items:
4. Number of Animals: 30 animals
5. Route of Administration: Intradermal injection, Dermal patch application
6. Study Duration: Thirty days (excluding quarantine and acclimatization period)
7. Evaluation Items:
(1) Daily clinical observations
(2) Irritation observation and scoring: Observation and scoring performed during the test and at 24 and 48 hours after the end of the test
(2) Irritation observation and scoring: Observation and scoring performed during the test and at 24 and 48 hours after the end of the test
Acute Systemic Toxicity Test
ISO 10993-11 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
1. Test Article Extraction: Two types of extracts (polar and non-polar)
2. Test Groups:
2. Test Groups:
Test Group: Test article extract (polar), Test article extract (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
3. Test Animals: ICR Mice
4. Number of Animals: 20 animals
5. Route of Administration: Tail vein injection and intraperitoneal injection
6. Dosing Frequency: Single administration
7. Study Duration: Four days (excluding quarantine and acclimatization period)
8. Evaluation Items:
4. Number of Animals: 20 animals
5. Route of Administration: Tail vein injection and intraperitoneal injection
6. Dosing Frequency: Single administration
7. Study Duration: Four days (excluding quarantine and acclimatization period)
8. Evaluation Items:
(1) Daily clinical observations
(2) Toxicity observation and scoring: Daily observation of appearance and behavior, and daily recording of body weight changes
(2) Toxicity observation and scoring: Daily observation of appearance and behavior, and daily recording of body weight changes
Subacute Systemic Toxicity Test
ISO 10993-11 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
1. Test Groups:
Test Group: Test article
Control Group: Control article
Control Group: Control article
2. Test Animals: Sprague-Dawley (SD) Rat
3. Number of Animals: 20 animals (10 males, 10 females)
4. Route of Administration: (To be Professionally evaluated by Master Laboratory Co., Ltd.)
5. Dosing Frequency: (To be Professionally evaluated by Master Laboratory Co., Ltd.)
6. Study Duration: 24 hours to 28 days (To be Professionally evaluated by Master Laboratory Co., Ltd.)
7. Evaluation Items:
3. Number of Animals: 20 animals (10 males, 10 females)
4. Route of Administration: (To be Professionally evaluated by Master Laboratory Co., Ltd.)
5. Dosing Frequency: (To be Professionally evaluated by Master Laboratory Co., Ltd.)
6. Study Duration: 24 hours to 28 days (To be Professionally evaluated by Master Laboratory Co., Ltd.)
7. Evaluation Items:
(1) Daily clinical observations
(2) Toxicity observation and scoring: Daily observation of appearance and behavior, weekly recording of food consumption and body weight changes, gross necropsy observations at termination
(3) Serum biochemical analysis
(4) Hematology
(5) Urinalysis
(6) Tissue sectioning
(7) Histopathological evaluation
(2) Toxicity observation and scoring: Daily observation of appearance and behavior, weekly recording of food consumption and body weight changes, gross necropsy observations at termination
(3) Serum biochemical analysis
(4) Hematology
(5) Urinalysis
(6) Tissue sectioning
(7) Histopathological evaluation
Chronic Systemic Toxicity Study
ISO 10993-11 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
1. Test Groups:
Test Group: Test article
Control Group: Control article
Control Group: Control article
2. Test Animals: Sprague-Dawley (SD) Rat
3. Number of Animals: 60 animals (30 males, 30 females)
4. Route of Administration: (To be professionally evaluated by Master Laboratory Co., Ltd.)
5. Dosing Frequency: (To be professionally evaluated by Master Laboratory Co., Ltd.)
6. Study Duration: 6-12 months (To be professionally evaluated by Master Laboratory Co., Ltd.)
7. Evaluation Items:
3. Number of Animals: 60 animals (30 males, 30 females)
4. Route of Administration: (To be professionally evaluated by Master Laboratory Co., Ltd.)
5. Dosing Frequency: (To be professionally evaluated by Master Laboratory Co., Ltd.)
6. Study Duration: 6-12 months (To be professionally evaluated by Master Laboratory Co., Ltd.)
7. Evaluation Items:
(1) Daily clinical observations
(2) Toxicity observation and scoring: Daily observation of appearance and behavior, weekly recording of food consumption and body weight changes, gross necropsy observations at termination
(3) Serum biochemical analysis
(4) Hematology
(5) Urinalysis
(6) Tissue sectioning
(7) Histopathological evaluation
(2) Toxicity observation and scoring: Daily observation of appearance and behavior, weekly recording of food consumption and body weight changes, gross necropsy observations at termination
(3) Serum biochemical analysis
(4) Hematology
(5) Urinalysis
(6) Tissue sectioning
(7) Histopathological evaluation
Subchronic Systemic Toxicity Test
ISO 10993-11 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
1. Test Groups:
Test Group: Test article
Control Group: Control article
Control Group: Control article
2. Test Animals: Sprague-Dawley (SD) Rat
3. Number of Animals: 40 animals (20 males, 20 females)
4. Route of Administration: (To be Professionally evaluated by Master Laboratory Co., Ltd.)
5. Dosing Frequency: (To be professionally evaluated by Master Laboratory Co., Ltd.)
6. Study Duration: (To be professionally evaluated by Master Laboratory Co., Ltd.)
7. Evaluation Items:
3. Number of Animals: 40 animals (20 males, 20 females)
4. Route of Administration: (To be Professionally evaluated by Master Laboratory Co., Ltd.)
5. Dosing Frequency: (To be professionally evaluated by Master Laboratory Co., Ltd.)
6. Study Duration: (To be professionally evaluated by Master Laboratory Co., Ltd.)
7. Evaluation Items:
(1) Daily clinical observations
(2) Toxicity observation and scoring: Daily observation of appearance and behavior, weekly recording of food consumption and body weight changes, gross necropsy observations at termination
(3) Serum biochemical analysis
(4) Hematology
(5) Urinalysis
(6) Tissue sectioning
(7) Histopathological evaluation
(2) Toxicity observation and scoring: Daily observation of appearance and behavior, weekly recording of food consumption and body weight changes, gross necropsy observations at termination
(3) Serum biochemical analysis
(4) Hematology
(5) Urinalysis
(6) Tissue sectioning
(7) Histopathological evaluation
Subchronic Systemic Toxicity Test via Dual Routes of Parenteral Administration
ISO 10993-11 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity — Annex H: Subchronic rat — Dual routes of parenteral administration, Annex H
1. Test Article Extraction: Two types of extracts (polar and non-polar)
2. Test Groups:
Test Group: Test article extract (polar), Test article extract (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
3. Test Animals: Sprague-Dawley (SD) Rat
4. Number of Animals: 24 animals (12 males, 12 females)
5. Route of Administration: Tail vein injection and intraperitoneal injection
6. Dosing Frequency:
4. Number of Animals: 24 animals (12 males, 12 females)
5. Route of Administration: Tail vein injection and intraperitoneal injection
6. Dosing Frequency:
Intravenous 14 times (daily administration)
Intraperitoneal 5 times (administered every three days)
Intraperitoneal 5 times (administered every three days)
7. Study Duration: Fourteen days (excluding quarantine and acclimatization period)
8. Evaluation Items:
8. Evaluation Items:
(1) Daily clinical observations
(2) Toxicity observation and scoring: Daily observation of appearance and behavior, weekly recording of food consumption and body weight changes, gross necropsy observations at termination
(3) Serum biochemical analysis
(4) Hematology
(5) Urinalysis
(6) Tissue sectioning
(7) Histopathological evaluation
(2) Toxicity observation and scoring: Daily observation of appearance and behavior, weekly recording of food consumption and body weight changes, gross necropsy observations at termination
(3) Serum biochemical analysis
(4) Hematology
(5) Urinalysis
(6) Tissue sectioning
(7) Histopathological evaluation
Pyrogen Test
USP <151> PYROGEN TEST
1. Test Article Extraction: Single extract
2. Test Group: Test article extract (polar)
3. Test Animals: New Zealand White (NZW) Rabbits
4. Number of Animals: 3 animals
5. Route of Administration: Single administration
6. Dosing Frequency: Single administration
7. Study Duration: One day. (excluding quarantine and acclimatization period)
8. Evaluation Items:
(1) Daily clinical observations
(2) Body temperature monitoring on the day of administration to evaluate the presence or absence of pyrogenic response
(2) Body temperature monitoring on the day of administration to evaluate the presence or absence of pyrogenic response
In Vivo Peripheral Blood Erythrocyte Micronucleus Test in Mice (MN Test)
ISO 10993-3 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
OECD Guidelines for the Testing of Chemicals, Section 4: TG 471 — Bacterial Reverse Mutation Test
OECD Guidelines for the Testing of Chemicals, Section 4: TG 471 — Bacterial Reverse Mutation Test
1. Test Article Extraction: Two types of extracts
2. Test System: CD-1 (ICR) mice
3. Test Groups: Negative Control Group, Positive Control Group, Two Extraction Solvent Control Groups, and Two Extract Groups
4. Test Conditions: Single or repeated dose administration via intraperitoneal or tail vein injection
5. Evaluation Item: Enumeration of micronucleated polychromatic erythrocytes (PCEs) or reticulocytes
In Vitro Mammalian Cell Gene Mutation Test Using the Thymidine Kinase Gene
ISO 10993-3 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
OECD Guidelines for the Testing of Chemicals, Section 4: TG 490 — In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene
OECD Guidelines for the Testing of Chemicals, Section 4: TG 490 — In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene
1. Test Article Extraction: Two types of extracts
2. Test System: L5178Y/TK+/- cells
3. Test Groups: Negative Control Group, Positive Control Group, Two Extraction Solvent Control Groups, and Two Extract Groups, performed in duplicates
4. Test Conditions:
Short-term treatment: with and without metabolic activation (S9 mix).
Long-term treatment: without metabolic activation (S9 mix)
Long-term treatment: without metabolic activation (S9 mix)
5. Evaluation Item: Cell mutation frequency
Bacterial Reverse Mutation Test (Ames Test)
ISO 10993-3 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
OECD Guidelines for the Testing of Chemicals, Section 4: TG 471 — Bacterial Reverse Mutation Test
1. Test Article Extraction: Two types of extracts
2. Test Strains: Salmonella typhimurium TA97a, TA98, TA100, TA102, TA1535
3. Test Groups: Negative Control Group, Positive Control Group, Two Extraction Solvent Control Groups, and Two Extract Groups, totaling 6 groups. Each group performed in triplicates
4. Test Conditions: Testing is performed with and without metabolic activation (S9 mix)
5. Evaluation Item: Analysis of the number of revertant colonies for each test group
1. Test Article Extraction: Two types of extracts
2. Test Strains: Salmonella typhimurium TA97a, TA98, TA100, TA102, TA1535
3. Test Groups: Negative Control Group, Positive Control Group, Two Extraction Solvent Control Groups, and Two Extract Groups, totaling 6 groups. Each group performed in triplicates
4. Test Conditions: Testing is performed with and without metabolic activation (S9 mix)
5. Evaluation Item: Analysis of the number of revertant colonies for each test group
Skin Sensitization Study (Guinea Pig Maximization Test)
ISO 10993-10 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
1. Test Article Extraction: Two types of extracts (polar and non-polar)
2. Test Groups:
Test Group: Test article extract (polar), Test article extract (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
Control Group: Extraction solvent (polar), Extraction solvent (non-polar)
3. Test Animals: Guinea Pigs
4. Number of Animals: 30 animals
5. Route of Administration: Intradermal injection, Dermal patch application
6. Study Duration: Thirty days (excluding quarantine and acclimatization period)
7. Evaluation Items:
4. Number of Animals: 30 animals
5. Route of Administration: Intradermal injection, Dermal patch application
6. Study Duration: Thirty days (excluding quarantine and acclimatization period)
7. Evaluation Items:
(1) Daily clinical observations
(2) Irritation observation and scoring: Observation and scoring performed during the test and at 24 and 48 hours after the end of the test
(2) Irritation observation and scoring: Observation and scoring performed during the test and at 24 and 48 hours after the end of the test
Subcutaneous Implantation Test
ISO 10993-6 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
1. Test Article Implantation: Size conforming to the standards. (To be professionally evaluated by Master Laboratory Co., Ltd.)
2. Test Groups:
Test Group: Test article
Control Group: Negative control
Control Group: Negative control
3. Test Animals: New Zealand White (NZW) Rabbits
4. Number of Animals: 3 animals
5. Route of Administration: Surgical subcutaneous implantation
6. Dosing Frequency: Single administration
7. Study Duration: (To be professionally evaluated by Master Laboratory Co., Ltd.)
8. Evaluation Items:
4. Number of Animals: 3 animals
5. Route of Administration: Surgical subcutaneous implantation
6. Dosing Frequency: Single administration
7. Study Duration: (To be professionally evaluated by Master Laboratory Co., Ltd.)
8. Evaluation Items:
(1) Daily clinical observations
(2) Daily observation of animal status post-surgery, animal body weight measurement during the test period
(3) Gross necropsy observations at termination
(4) Tissue sectioning
(5) Histopathological evaluation
(2) Daily observation of animal status post-surgery, animal body weight measurement during the test period
(3) Gross necropsy observations at termination
(4) Tissue sectioning
(5) Histopathological evaluation
Muscle Implantation Test
ISO 10993-6 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
1. Test Article Implantation: Size conforming to the standards. (To be professionally evaluated by Master Laboratory Co., Ltd.)
2. Test Groups:
Test Group: Test article
Control Group: Negative control
Control Group: Negative control
3. Test Animals: New Zealand White (NZW) Rabbits
4. Number of Animals: 3 animals
5. Route of Administration: Surgical intramuscular implantation
6. Dosing Frequency: Single administration
7. Study Duration: (To be professionally evaluated by Master Laboratory Co., Ltd.)
8. Evaluation Items:
4. Number of Animals: 3 animals
5. Route of Administration: Surgical intramuscular implantation
6. Dosing Frequency: Single administration
7. Study Duration: (To be professionally evaluated by Master Laboratory Co., Ltd.)
8. Evaluation Items:
(1) Daily clinical observations
(2) Daily observation of animal status post-surgery, animal body weight measurement during the test period
(3) Gross necropsy observation after sacrifice
(4) Tissue sectioning
(5) Histopathological evaluation
(2) Daily observation of animal status post-surgery, animal body weight measurement during the test period
(3) Gross necropsy observation after sacrifice
(4) Tissue sectioning
(5) Histopathological evaluation
Bone Implantation Test
ISO 10993-6 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
1. Test Article Implantation: Size conforming to the standards. (To be professionally evaluated by Master Laboratory Co., Ltd.)
2. Test Groups:
Test Group: Test article
Control Group: Negative control
Control Group: Negative control
3. Test Animals: New Zealand White (NZW) Rabbits
4. Number of Animals: 5 animals
5. Route of Administration: Surgical Implantation in the Femur
6. Dosing Frequency: Single administration
7. Study Duration: (To be professionally evaluated by Master Laboratory Co., Ltd.)
8. Evaluation Items:
4. Number of Animals: 5 animals
5. Route of Administration: Surgical Implantation in the Femur
6. Dosing Frequency: Single administration
7. Study Duration: (To be professionally evaluated by Master Laboratory Co., Ltd.)
8. Evaluation Items:
(1) Daily clinical observations
(2) Daily observation of animal status post-surgery, animal body weight measurement during the test period
(3) Gross necropsy observation after sacrifice
(4) Tissue sectioning
(5) Histopathological evaluation
(2) Daily observation of animal status post-surgery, animal body weight measurement during the test period
(3) Gross necropsy observation after sacrifice
(4) Tissue sectioning
(5) Histopathological evaluation
22-Day Ocular Irritation Test (Rabbit Contact Lens Wear Test)
ISO 9394 Ophthalmic optics — Contact lenses and contact lens care products — Determination of biocompatibility by ocular study with rabbit eyes
1. Test Article: Direct contact lens wear
2. Test Groups:
Test Group: Test Article
Control Group: Control Article
Control Group: Control Article
3. Test Animals: New Zealand White (NZW) Rabbits
4. Number of Animals: 6 animals
5. Route of Administration: Ocular contact
6. Dosing Frequency: Daily.
7. Study Duration: Twenty-two days (excluding quarantine and acclimatization period)
8. Evaluation Items:
4. Number of Animals: 6 animals
5. Route of Administration: Ocular contact
6. Dosing Frequency: Daily.
7. Study Duration: Twenty-two days (excluding quarantine and acclimatization period)
8. Evaluation Items:
(1) Daily clinical observations
(2) Daily observation of animal status and test article condition, periodic Fluorescein staining and slit-lamp biomicroscopy
(3) Tissue sectioning of the application site
(4) Histopathological evaluation
(2) Daily observation of animal status and test article condition, periodic Fluorescein staining and slit-lamp biomicroscopy
(3) Tissue sectioning of the application site
(4) Histopathological evaluation
Repeated Dose 28-day Oral Toxicity Study
OECD Guidelines for the Testing of Chemicals, Section 4: TG 407 — Repeated Dose 28-Day Oral Toxicity Study in Rodents
1. Test Article Dosage: (To be professionally evaluated by Master Laboratory Co., Ltd.)
2. Test Groups:
Test Group: Low dose
Test Group: Mid dose
Test Group: High dose
Control Group: Negative control
Test Group: Mid dose
Test Group: High dose
Control Group: Negative control
3. Test Animals: Sprague-Dawley (SD) Rat
4. Number of Animals: 80 animals (40 males, 40 females)
5. Route of Administration: Oral gavage
6. Dosing Frequency: Daily
7. Study Duration: 28 days (excluding quarantine and acclimatization period)
8. Evaluation Items:
4. Number of Animals: 80 animals (40 males, 40 females)
5. Route of Administration: Oral gavage
6. Dosing Frequency: Daily
7. Study Duration: 28 days (excluding quarantine and acclimatization period)
8. Evaluation Items:
(1) Daily clinical observations
(2) Toxicity observation and scoring: Daily observation of appearance and behavior, weekly recording of food consumption and body weight changes, gross necropsy observation after sacrifice
(3) Serum biochemical analysis (Clinical Chemistry)
(4) Hematology
(5) Urinalysis
(6) Tissue sectioning
(7) Histopathological evaluation
(2) Toxicity observation and scoring: Daily observation of appearance and behavior, weekly recording of food consumption and body weight changes, gross necropsy observation after sacrifice
(3) Serum biochemical analysis (Clinical Chemistry)
(4) Hematology
(5) Urinalysis
(6) Tissue sectioning
(7) Histopathological evaluation
Acute Oral Toxicity Study (Limit Test)
OECD Guidelines for the Testing of Chemicals, Section 4: TG 420 — Acute Oral Toxicity — Fixed Dose Method
OECD Guidelines for the Testing of Chemicals, Section 4: TG 423 — Acute Oral Toxicity — Acute Toxic Class Method
1. Test Article Dosage: (To be professionally evaluated by Master Laboratory Co., Ltd.)
2. Test Groups:
Test Group
Control Group
Control Group
3. Test Animals: Sprague-Dawley (SD) Rat
4. Number of Animals: 20 animals (10 males, 10 females)
5. Route of Administration: Oral gavage
6. Dosing Frequency: Single administration
7. Study Duration: 14 days (excluding quarantine and acclimatization period)
8. Evaluation Items:
4. Number of Animals: 20 animals (10 males, 10 females)
5. Route of Administration: Oral gavage
6. Dosing Frequency: Single administration
7. Study Duration: 14 days (excluding quarantine and acclimatization period)
8. Evaluation Items:
(1) Daily clinical observations
(2) Toxicity observation and scoring: Daily observation of appearance and behavior, weekly recording of food consumption and body weight changes, gross necropsy observation after sacrifice
(2) Toxicity observation and scoring: Daily observation of appearance and behavior, weekly recording of food consumption and body weight changes, gross necropsy observation after sacrifice