BAIJIAN - Material testing agency
Instruments、 equipment、 materials、 and other similar related items directly or indirectly used in the human body are the interpretation of medical devices. The purpose of using medical devices is to diagnose diseases、 injuries、 support life、 or maintain information for medical or diagnostic purposes by examining samples from the human body. As an important component of the pharmaceutical industry、 for consumers、 the configuration of medical equipment in medical institutions is second only to the standard used by physicians to evaluate medical institutions. Medical devices are related to human health and safety、 and their related issues have become a common focus of concern for manufacturers and consumers. Applicable products: 1. Active product related multi-parameter monitors、 ultrasound diagnostic equipment、 infusion pumps and controllers、 thermometers、 non-invasive blood pressure monitoring equipment、 pulse photoelectric oxygen meter equipment、 high-frequency electrosurgical surgical equipment、 nerve and muscle stimulators、 endoscopes、 EEG machines、 surgery、 makeup、 diagnostic and therapeutic laser equipment、 electrocardiogram diagnostic equipment、 clinical chemical analysis instruments、 immunochemical analysis instruments Fully automatic blood analysis instrument、 microbial analysis instrument、 fully automatic protein analyzer、 biochemical analyzer、 blood cell analyzer、 blood gas analyzer、 chemiluminescence immunoassay analyzer、 urine sediment analyzer、 hemagglutination analyzer、 fully automatic blood rheometer、 fully automatic internal bacterial culture analyzer、 microbial identification and bacterial drug sensitivity analyzer、 nucleic acid purification instrument、 blood tissue culture instrument、 frozen slicer、 biological tissue dehydrator、 Tissue embedding machine、 centrifuge、 mixer、 dyeing machine、 high-temperature pulsating vacuum sterilizer、 high-temperature steam sterilizer、 infrared electric sterilizer、 high-temperature disinfection cleaning machine、 biosafety cabinet、 etc. 2、 Passive product related 1. Surface contact device electrodes、 external prostheses、 fixed straps、 compression bandages、 and various types of monitors. Contact lenses、 catheters、 vaginal or gastrointestinal instruments (such as gastric tubes、 colonoscopes、 gastroscopes)、 endotracheal intubations、 bronchoscopes、 and other dressings or care devices for ulcers、 burns、 granulation tissue、 and sealing applications. 2. External access devices such as blood transfusions、 infusion sets、 extenders Laparoscopy such as transfer devices、 joint endoscopes、 drainage systems、 dental filling materials、 intravascular catheters such as skin nails、 temporary pacing electrodes、 dialyzers、 dialysis pipelines and accessories、 vascular adsorbents、 immune adsorbents、 etc. 3. Implant devices such as orthopedic nails、 artificial joints、 bone prostheses、 bone cement、 and bone instruments、 pacemakers、 implantable drug delivery devices、 neuromuscular sensors and stimulators、 artificial tendons、 breast implants、 etc 4. Routine safety tests for in vitro diagnostic reagents (medical laboratory reagents) testing items: temperature rise、 withstand voltage、 leakage current、 defibrillation protection test、 mechanical test、 single fault test、 etc. Electromagnetic compatibility testing: power terminal disturbance voltage、 radiation disturbance、 harmonic current、 voltage fluctuation and flicker、 electrostatic discharge immunity、 radio frequency radiation immunity、 power frequency magnetic field immunity、 electrical fast transient pulse group immunity、 radio frequency conduction immunity、 surge immunity、 voltage sag、 short-term interruption、 and voltage change immunity. Product specific testing: such as precision testing of blood pressure、 blood oxygen、 infusion pumps and infusion controllers、 as well as performance testing of a series of products such as monitoring、 nerve and muscle stimulators. Biocompatibility: In vitro cytotoxicity test、 Salmonella typhimurium mutagenesis test、 sensitization test、 gene mutation test、 thrombosis test、 skin stimulation test、 intradermal stimulation test、 coagulation test、 acute systemic toxicity test、 subacute systemic toxicity test、 platelet adhesion test、 complement activation test、 subchronic systemic toxicity test、 chronic systemic toxicity test、 muscle implantation test、 hemolysis test Heat source test、 chromosome aberration test、 bone implantation test、 bone marrow micronucleus test、 material characteristic analysis、 subcutaneous implantation test; Endotoxin physics Packaging validation、 cleaning and disinfection validation、 biosafety evaluation、 preclinical functional evaluation、 microbial testing、 virus inactivation、 chemical performance testing:
Medical device testing standards AS/NZS 4810.1-2000 Medical device risk management Part 1: Application of risk analysis (ISO 14971-1:1998) ASTM F639-2009 (2015) Specification for Polyethylene Plastics for Medical Devices ASTM F813-2007、 Evaluation Procedure for Direct Contact Cell Culture of Materials Used in Medical Devices BB/T 0059-2012、 Coextrusion Film for Plastic Packaging of Medical Devices BS DD-ENV 12611-1998、 Category Structure of the Medical Information Science Concept System、 Medical Devices BS DD-ENV 13735-2001、 Interoperability of Medical Devices for Health Information Science and Patient Connection、 BS EN 556-2-2003、 Disinfection of Medical Devices、 Labeled "STERILE" Requirements for medical devices - Part 2: Requirements for sterile handling of medical supplies - BS EN ISO 10993-1-2009 Biological evaluation of medical devices - Part 1: Evaluation and testing - BS EN ISO 10993-2-2006 Biological evaluation of medical devices - Animal equipment requirements - BS EN ISO 10993-3-2009 Biological evaluation of medical devices - Genetic toxicity、 carcinogenicity、 and reproductive toxicity testsFunction of testing report:
1. Project bidding: Issue authoritative third-party CMA/CNAS qualification report
2. Online e-commerce platform entry: Quality inspection report recognized by major e-commerce platforms 3. Used as a sales report: issuing legally effective testing reports to make consumers more confident 4. Papers and research: Provide professional personalized testing needs 5. Judicial services: providing scientific、 fair、 and accurate testing data 6. Industrial problem diagnosis: Verify the troubleshooting and correction of industrial production problemsinspection and testing process:
1. Telephone communication and confirmation of requirements
2. Recommend solutions and confirm quotations 3. Mail samples and arrange testing 4. Progress tracking and result feedback 5. Provide reports and after-sales service 6. If urgent or priority processing is requiredTesting and testing characteristics:
1. The testing industry is fully covered、 meeting different testing needs
2. Fully cover the laboratory and allocate localized testing nearby3. Engineers provide one-on-one services to make testing more accurate
4. Free initial testing、 with no testing fees charged
5. Self service order delivery for free on-site sampling
6. Short cycle、 low cost、 and attentive service 7. Possess authoritative qualifications such as CMA、 CNAS、 CAL、 etc 8. The testing report is authoritative and effective、 and is generally used in China