The UN3373 95kPa Specimen Bag

The UN3373 95kPa Specimen Bag, a type of transport bag that meets the UN3373 standard and can

withstand an internal pressure of 95kPa, is primarily used for the storage and transportation of hazardous

materials such as infectious specimens, pathogenic microorganisms, blood, vaccines, and more, in medical

and scientific research fields. Below is an overview of the requirements for manufacturers producing this

type of transport bag:

I. Production Qualifications and Certifications

• Production Qualifications: Manufacturers must possess relevant production qualifications, such as a medical device production license (if the product is classified as a medical device) and an industrial product production license.
• Certification Requirements: Products must pass relevant international or domestic standard certifications, such as ISO certification, CE certification (for the European market), FDA registration (for the US market), etc., to ensure that their quality and safety comply with international standards.

II. Technical Requirements

• Material Selection: Transport bags should be made from high-quality, durable materials like polyethylene (PE) or polypropylene (PP), which possess excellent sealing properties, impermeability, and weather resistance to meet operational needs under various environmental conditions.
• Structural Design: The product’s structural design should be rational, capable of withstanding an internal pressure of 95kPa within a temperature range of -40°C to +55°C without leakage. Additionally, it must ensure that samples remain uncontaminated, undamaged, and do not leak during transportation.
• Labeling and Marking: Transport bags must clearly display labels such as “UN3373” and “Biohazard,” along with necessary warning messages and transportation information, to facilitate proper handling during transportation and storage.

III. Quality Control

• Production Process Control: Manufacturers should establish a comprehensive quality management system to strictly control raw material procurement, production processing, and final product inspection, ensuring stable and reliable product quality.
• Product Inspection: Each batch of products must undergo rigorous inspections and tests before leaving the factory, including pressure tests, sealing tests, weather resistance tests, etc., to ensure compliance with relevant standards and customer requirements.

IV. Compliance with Regulations

• International Transportation Regulations: Manufacturers must be familiar with and comply with international transportation regulations, such as the Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Doc 9284) and the International Air Transport Association’s Dangerous Goods Regulations (IATA DGR), to ensure compliance with requirements for air, land, and sea transportation.
• Environmental Regulations: During production and waste disposal, manufacturers must adhere to environmental regulations to minimize environmental impact.

V. Other Requirements

• Customized Services: Provide customized services based on customer needs, such as different sizes, colors, and printed patterns, to meet various application scenarios.
• After-Sales Service: Offer a comprehensive after-sales service system, including product consultation, technical support, and return and exchange services, to ensure timely and effective assistance during customer use.

In conclusion, manufacturers producing UN3373 95kPa Specimen Bags must possess diverse capabilities

and qualifications to ensure that their products meet international standards and customer requirements

in terms of quality and safety. When making a selection, it is advisable to comprehensively evaluate

factors such as the manufacturer’s production strength, product quality, pricing, and after-sales service.