Contact Us
Find out more about service
Contact us

FDA Guidance ISO 10993

Biocompatibility Testing

The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. For the purpose of the ISO 10993 family of standards, biocompatibility is defined as the "ability of a medical device or material to perform with an appropriate host response in a specific application".


ISO 10993-1-2018 biocompatibility testing.pdf

If you need help with ISO 10993, please leave your contact information and we'll be happy to help you!


We are dedicated to providing testing, certification and technical regulations consulting services to help global market access and international trade. For technical regulation support, technicians at HTW are able to help understand technical regulations and product design specifications. 


HTW lab provide professional Biocompatibility testing services that will help get your products to market faster, enabling greater sales and revenue.Communicate with our experts to determine your needs and we will provide you with an evaluation, proposal and quotation.


HTW Lab, accredited by CNAS, CMA, CNCA & A2LA, consistently operates competently and generates accurate and valid results in accordance with ISO/IEC 17025. Our lab meets the requirements of Good Laboratory Practice (GLP) and provides product testing service in accordance with national and global standards for both active and non-active medical devices. We are also IECEE CB Scheme Test Laboratory (CBTL). Thus, testing reports from HTW Lab can be accepted between countries.


ISO 10993

Non-active | Biocompatibility

Number

Project

Standard

1.          

Evaluation and testing within a risk management process

ISO10993-1 , G B16886.1

2.          

Ethylene oxide sterilization residuals (ETO,ECH,EO)

ISO10993-7 , G B16886.7

3.          

In vitro cytotoxicity test

ISO10993-5 , G B16886.5

4.          

Sensitization test

ISO10993-10 , GB16886.10

5.          

Skin, intradermal and oral mucosal irritation test

ISO10993-10 , GB16886.10

6.          

Irritation test

ISO10993-23

7.          

Acute systemic toxicity test

ISO10993-11 , GB16886.11

8.          

Subacute systemic toxicity test

ISO10993-11 , GB16886.11

9.        

Subchronic systemic toxicity test

ISO10993-11 , GB16886.11

10.      

Chronic systemic toxicity test

ISO10993-11 , GB16886.11

11.      

Material-mediated Pyrogens

Test

ISO10993-11 , GB16886.11

12.      

In vitro Mammalian

Chromosome Aberration Test

ISO10993-3 , GB16886.3ISO10993-33

13.      

Micronuclear test

ISO10993-3 , GB16886.3ISO10993-33

14.      

In Vitro Mammalian Cell Gene Mutation Test

ISO10993-3 , GB16886.3ISO10993-33

15.      

Ames test

ISO10993-3 , GB16886.3ISO10993-33

16.      

Thrombogenesis  test

ISO10993-4 , GB16886.4

17.      

Coagulation test

ISO10993-4 , GB16886.4

18.      

Platelet adhesion test

ISO10993-4GB16886.4

19.      

Complement activation test

ISO10993-4GB16886.4

20.      

Hemolysis test

ISO10993-4GB16886.4

21.      

Muscle implantation test

ISO10993-6GB16886.6

22.      

Subcutaneous implantation test

ISO10993-6GB16886.6

23.      

Bone implant test

ISO10993-6GB16886.6

24.      

Material characteristic analysis

ISO10993-18



HTW Testing and Certification Solutions.

Product We Test



Active Products

1. Diagnostic equipment

Physical Diagnostic Kits 

Thermometer, Blood Pressure, Microscope, Audiometer, Various Physiological Recorders, Etc.

Medical Image

X-ray, Ct Scan, Mri, B-scan Ultrasonography

Analytical Instruments

All Types Of Counter, Biochemical, Immune Analysis Instruments, Etc.

Electrophysiology

Electrocardiogram, Electroencephalograph, Electromyograph, Etc.

2. Treatment Equipment

Common Surgical Instruments

/

Optical Surgical Instruments

Fiber Endoscope, Laser Therapeutic Apparatus, Etc.

Auxiliary Surgical Instruments

Anesthesia Machines, Respirator, Extracorporeal Circulation, Etc.

Radiotherapy Machinery

Deep X-ray Therapeutic Apparatus, Cobalt-60 Therapeutic Apparatus, Accelerator, Gamma Knife, Isotope Therapeutic Apparatus, Etc.

Others

Microwave, Hyperbaric Oxygen, Etc.

Non-active Products

1. Surface Contact Apparatus

Electrodes, External Prosthetics, Straps, Compression Bandages And Monitors;

Contact Lenses, Catheters, Intravaginal Or Gastrointestinal Instruments;

Nursing Apparatus And Sealing Applicator;

2. External Access Device

Blood Transfusion, Infusion Set, Extender, Transfer Device, Etc;

Endoscope, Drainage System, Dental Filling Materials, Etc;

Intravascular Catheters, Temporary Pacing Electrodes, Dialyzers, Dialysis Tubes And Accessories, Vascular Adsorbents, Immune Adsorbents, Etc.

3. Personal Protective Equipment

Medical Masks, Medical Protective Clothing, Medical Gloves, Medical Goggles, Melt-blown Cloth, Etc

4. Implanted Devices

Orthopaedic Nails, Artificial Joints, Bone Prostheses, Bone Cement And Intraosseous Devices, Pacemakers, Implantable Drug Delivery Devices, Neuromuscular Sensors And Stimulators, Artificial Tendons, Breast Implants, Artificial Larynx, Subperiosteal Implants, Ligation Clips, Etc


Testing We Support

In Vitro Cytotoxicity Test

Subacute Systemic Toxicity Test

Subchronic Systemic Toxicity Test  

Sensitization Test

Genetic Mutation Test

Skin And Intradermal Irritation Test

Oral Irritation Test

Eye Irritation Test

Irritation Vaginal,Penis, Rectal

Salmonella Typhimurium / Ames

Thrombosis Test

Intradermal Reactivity Test

Coagulation Test

Platelet Adhesion Test

Complement Activation Test

Muscle Implantation Test

Hemolysis Test

Material-mediated Pyrogen Test

Chromosome Aberration Test

Bone Implant Test

Bone Marrow Micronucleus Test

Material Characteristics Analysis

Subcutaneous Implantation Test

Systemic Of Injection Test

Acute Oral Irritation Test

Elution Test

Micronucleus Test

Gene Mutation Test

The Hemolysis Test

Hematologic Test

Pyrogens


Service Procedure

1. Provide us with product pictures, product brochures/manuals

2. Determine your needs(test report purpose/ test itmes/ standards)

3. Receive the testing/compliance service proposal and quotation 

4. Sign contract and make payment

5.Send samples (please contact us for address info.)

6.Informed project opening and test TAT(turn around time) via email

7.Testing 

8.Draft report for your confirmation

9. Formal reports endorsed by ILAC - CNAS (electronic version) 

10.Sample Discard or Return

Biocompatibility Testing for Medical Device

Class I, II, and III Medical Devices Testing and Certification

Patient Monitoring Devices Testing

Wireless Medical Device Testing

Cardiovascular Device Testing

Chemical Analysis for Medical Device Components

Medical Device Packaging Validation

Physical Testing of Medical Devices and IVD Equipment

Electrical Safety Testing (IEC 60601-1)

EMC Testing for Medical Devices

Functional Safety Testing of Medical Devices 

Wireless Testing for Medical Devices

In Vitro Diagnostic Medical Devices Testing


Contact us to learn more about our orthopedic implant testing, cardiovascular device testing,  biocompatibility testing, medical device packaging validation, radio frequency testing, EMI & EMC testing and others.

Contact Us
First name*
Last Name*
Job title
Company name
Email address*
Phone number
Message*
HTW Lab
Product Testing and Certification

Call: 86-0755-26748009

Email: sales@htwlab.com


"Communicate with our experts to determine your needs and we will provide you with an evaluation, proposal and quotation"

Address: 1/F, Bldg5, Hongfa Hi-tech Industrial Park, Tianliao, Guangming, Shenzhen City, Guangdong Province, P.R. China 

ISO/IEC 17025 Accredited. 
CNAS.

ILAC.
GLP Laboratory.
CMA.
A2LA.

CBTL.