Biological Evaluation

For the medical device intended to be used for human body, firstly, qualitative analysis on the material used and analysis on existing data or relevant information are performed before the clinical trial. Then simulated in vitro biological test is performed. The in vivo animal test is performed as needed. Based on comprehensive information and data analysis and/or safety test assessment, a relatively scientific evaluation is finally made to risks of this medical device.

Subordinated to Tigermed-Jyton Group, Hangzhou Tiger Jyton Testing Technology Co., Ltd. is a third-party testing organization for medical devices, which is founded in accordance with CNAS standards and accredited by CNAS and CMA. The company has a nearly 2500 m² professional laboratory and SPF animal laboratories. Almost all animals are from world-renowned suppliers accredited by AAALAC. The strictest standard of the industry is followed for relevant experiments. Safety and daily care of animals conform to and even exceed international standards, to ensure comfort and health of animals. The experiment data are accurate and reliable.

Team Advantages

More than 75% team members having a master degree or above

3 deputy senior engineers and above

5 laboratory certified internal auditors (ISO/IEC 17025: 2017)

10+ years’ experience of safety evaluation for medical devices

Working experience in Top 10 national inspection centers

Working experience in NMPA respiratory pharmacology laboratory

Experience in drug safety evaluation of Chinese Academy of Sciences

Working experience in world-renowned device/technical service manufacturers

Laboratory Features

Comply with AAALAC and FDA accreditation standards and the strictest standards of animal welfare

Accredited by CNAS and CMA

First-class customer service

Efficient experiment arrangement and high-quality experiment report

Professional project management

Regulatory Compliance

Completely meet regulatory requirements of NMPA

The supporting experiments and project design comply with guiding principles of global regulations

The experiment design complies with guiding principles of different institutions based on customer requirements

Organization Profile

Standardized design, HEPA-filtration, computerized early-warning monitoring and control

The animal house of 800+ m2 can accommodate laboratory animals such as New Zealand rabbits, guinea pigs, rats and mice

The rodent house uses the SPF barrier system and meets specific requirements of FDA and NMPA.

The facility is equipped with the outage emergency system and the standby support system for the water treatment system.

The organization provides customized service for long-term clients.

Modern Equipment

First-class equipment conforming to industrial standard

Advanced electronic information recording and storage

Fully-validated electronic detection systems are used to realize environment control and monitor laboratory equipment and safety.

Relevant Standards

GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use--Part 2: Biological test methods

GB/T 16886.4-2003 Biological evaluation of Medical devices--Part 4: Selection of tests for interactions with blood

GB/T 16886.5-2017 Biological evaluation of Medical devices--Part 5: Tests for in vitro cytotoxicity

GB/T 16886.10-2017 Biological evaluation of medical devices--Part 10: Tests for irritation and skin sensitization

GB/T 16175-2008 Biological evaluation test methods for medical organic silicon materials

YY/T 0127.2-2009 Biological evaluation of medical devices used in dentistry--Part 2: Test method--Acute systemic toxicity: intravenous path

YY/T 0127.9-2009 Biological evaluation of medical devices used in dentistry--Part 2: Test method--Cytotoxicity tests: Agar diffusion test and filter diffusion test

GB/T 16886.11-2011 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity

ISO 10993-11-2017 (E) Biological evaluation of medical devices--Part 11: Tests for systemic toxicity

YBB 00012003-2015 Test for cytotoxicity

YY/T 0993-2015 Biological evaluation of medical devices--Nanomaterial: in vitro cytotoxicity tests (MTT assay and LDH assay)

Chinese Pharmacopoeia 2015 edition, Undue Toxicity Test

Medical Device Testing Services Provided:

Biological risk assessment and biocompatibility test

Cytotoxicity test

Genotoxicity test

Blood compatibility test

Implantation test

Sensitization test

Irritation test

Systemic toxicity test (acute)

Chronic and subchronic test

Service