Medical devices and their raw materials, components, and packaging testing

Material Analysis 百检检测 2024-07-10

GB/T 14233.1-2008#Medical infusion, blood transfusion, and injection equipment - Inspection methods - Part 1: Chemical analysis methods - Medical devices and their raw materials, components, and packaging materials - pH value (acidity, alkalinity, pH value)

Pharmacopoeia of the People's Republic of China#PH value (acidity, alkalinity, acidity and alkalinity), Pharmacopoeia of the People's Republic of China, 2020 Edition, Part 4 General Rule 0631 # Medical Devices and Their Raw Materials, Components, and Packaging # pH value (acidity, alkalinity, acidity and alkalinity)

GB/T 16886.11-2011#Biological evaluation of medical devices - Part 11: Systemic toxicity testing # Medical devices and their raw materials, components, and packaging # Subacute, subchronic, and chronic systemic toxicity

Technical Specifications for Disinfection#Subacute, Subchronic, and Chronic Systemic Toxicity "Disinfection Technical Specifications" 2002 Edition 2.3.7, 2.3.9, 2.3.11 # Medical Devices and Their Raw Materials, Components, and Packaging # Subacute, Subchronic, and Chronic Systemic Toxicity

GB/T 14233.2-2005#Medical infusion, blood transfusion, and injection equipment - Inspection methods - Part 2: Biological test methods - Medical devices and their raw materials, components, and packaging materials - Subacute, subchronic, and chronic systemic toxicity

GB/T 16175-2008#Biological evaluation test methods for medical silicone materials # Medical devices and their raw materials, components, and packaging materials # Subacute, subchronic, and chronic systemic toxicity

GB/T 16886.10-2017#Biological evaluation of medical devices - Part 10: Irritation and skin sensitization tests # Medical devices and their raw materials, components, and packaging materials # Animal irritation tests (skin irritation)

GB/T 16175-2008#Biological evaluation test methods for medical silicone materials # Medical devices and their raw materials, components, and packaging materials # Animal irritation test (skin irritation)

IS 15745-2007#Reflection for straight side mechanical pressures # Medical devices and their raw materials, components, and packaging materials # Animal irritation tests (skin irritation)

IS 15745-2007#Reflection for straight side mechanical pressures # Medical devices and their raw materials, components, and packaging materials # Animal skin reaction tests

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 problems

BAIJIAN inspection 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 required

Testing and testing characteristics:

1. The testing industry is fully covered, meeting different testing needs

2. Fully cover the laboratory and allocate localized testing nearby

3. 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

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