BAIJIAN - Material testing agency
Disposable non intravascular catheters/wires or intravascular imaging wires are widely used in clinical practice. Medical wires require long-term or short-term contact with body tissues、 and patients may experience varying degrees of burning pain when inserting or pulling out tissues、 which can easily cause corresponding mucosal damage and even tissue inflammation. This is mainly due to the high friction between the surface material of the guide wire and the body tissue. Applicable products: Non vascular catheters include: gastric tubes、 drainage tubes、 sterile catheters、 nasal feeding tubes Negative pressure drainage tube testing project: Corrosion resistance of metal components of the tube. Tube tensile performance. Hydraulic leakage resistance test. Suction or vacuum leakage resistance test. Tube water flow rate test. Tube connector firmness test. Non vascular catheter testing standard:
Standard number
Standard name
GB/T 191-2008
"Packaging、 storage and transportation graphical symbols"
GB/T 2828.1-2012
GB/T 15812.1-2005
Non vascular catheters - Part 1: General performance test methods
GB/T 16886.1-2011
Biological evaluation of medical devices - Part 1: Evaluation and testing during risk management
GB/T 16886.3-2008
Biological evaluation of medical devices - Part 3: Genetic toxicity、 carcinogenicity、 and reproductive toxicity testing
GB/T 16886.5-2003
Biological Evaluation of Medical Devices - Part 5: In Vitro Cytotoxicity Testing
GB/T 16886.6-1997
Biological Evaluation of Medical Devices - Part 6: Local Response Testing after Implantation
GB/T 16886.10-2005
Biological Evaluation of Medical Devices - Part 10: Stimulation and Delayed Type Hypersensitivity Testing
GB/T 16886.11-2011
Biological Evaluation of Medical Devices - Part 11: Systemic Toxicity Testing
YY/T 0466.1-2009
"Symbols for Medical Device Labeling、 Labeling、 and Providing Information - Part 1: General Requirements"
YY 0489-2004
"Disposable Sterile Drainage Catheters and Auxiliary Devices"
GB 18278.1-2015
"Sterilization of Healthcare Products - Part 1: Development、 Confirmation、 and Routine Control Requirements for the Sterilization Process of Medical Devices"
GB 18279.1-2015Sterilization of Healthcare Products - Part 1: Requirements for Development、 Validation、 and Routine Control of the Sterilization Process for Medical Devices (GB/T 18279.2-2015)
GB 18280.2-2015
"Sterilizing Radiation for Healthcare Products - Part 2: Establishing Sterilization Dose"
GB/T 18280.3-2015
"Sterilizing Radiation for Healthcare Products - Part 3: Guidelines for Dose Measurement"
GB/T 19633.1-2015
"Packaging for Final Sterilized Medical Devices - Part 1: Requirements for Materials、 Sterile Barrier Systems、 and Packaging Systems"
YY/T 0313-2014
"Packaging of Final Sterilized Medical Devices - Part 2: Requirements for Forming、 Sealing、 and Assembly Process Confirmation"
"Packaging of Medical Polymer Products and Requirements for Information Provided by Manufacturers"
YY 0325-2016
"Disposable Sterile Urinary Catheters"
YY/T 0681.1-2009
"Test Methods for Sterile Medical Device Packaging - Part 1: Guidelines for Accelerated Aging Testing"
YY/T 0698.1-2011Final sterilization of medical device packaging materials - Part 1: Requirements and test methods for co extruded plastic films for blister packaging "
YY/T 0316-2016" Application of medical device risk management to medical devices "
GB/T 1962.1-2015
" 6% (ruhr) conical joints for syringes、 needles、 and other medical devices - Part 1: General requirements "
GB/T 1962.2-2001
6% (Ruhr) Conical Connectors for Syringes、 Syringes、 and Other Medical Devices - Part 2: Locking Connectors
YY 0450.1-2003
Disposable Sterile Intravascular Catheter Accessories - Part 1: Guiding Devices
YY 0483-2004
Design and Test Methods for Disposable Enteral Nutrient Catheters、 Enteral Suppliers、 and Their Connections
YY/T 0615.1-2007Labeling "Sterile"
Requirements for Medical Devices - Part 1: Requirements for Final Sterilized Medical DevicesYY/T0148-2006
"General Requirements for Medical Tape"
YY/T0471.1-2004
; Test methods for contact wound dressings - Part 1: Liquid absorption
YY/T 0471.2-2004
Test methods for contact wound dressings - Part 2: Water vapor permeability of breathable film dressings
YY/T 0471.3-2004
Test methods for contact wound dressings - Part 3: Water resistance
YY/T 0471.4-2004
; Test methods for contact wound dressings - Part 4: Comfort
GB/T 2828.1-2003
"Sampling procedures for inspection by attributes - Part 1: Sampling plan for batch by batch inspection based on acceptance quality limit (AQL) retrieval"
YY 0483-2004
"Design and testing methods for disposable enteral nutrition catheters、 enteral nutrition devices and their connectors"
Function 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