Disposable Antibacterial Hygiene Products Certification

Core Content of Certification

The certification of disposable antimicrobial sanitary products focuses on the hygiene safety and antibacterial performance of the products, examining the following dimensions:

Antibacterial Performance: Based on the CTS CRCB034-2026 technical specification, the bactericidal rates against *Escherichia coli* and *Staphylococcus aureus* are tested. For disposable sanitary products with antibacterial functions, the bactericidal rate against *E. coli* and *S. aureus* must be greater than or equal to 90%, and the bactericidal rate using the shake flask test method must be greater than 26%. If the product claims to be effective against pathogenic yeasts or other microorganisms, the bactericidal rate against *Candida albicans* or the corresponding microorganism must also meet the above requirements.

Bacteriostatic Performance: The bacteriostatic function of the product is tested. For disposable sanitary products with bacteriostatic functions, the bacteriostatic rate against *E. coli* and *S. aureus* must be greater than or equal to 50%, the bacteriostatic rate using the shake flask test method must be greater than 26%, and for superabsorbent materials, the bacteriostatic rate must be greater than or equal to 99%, or the inhibition zone diameter must be greater than 7.0 mm.

Microbiological Indicators: The total bacterial count and total fungal count of the product are tested. For antimicrobial and bacteriostatic products, the total bacterial count must not exceed 20 CFU/g, and the total fungal count must not be detectable. Specific microorganisms such as coliforms, *Pseudomonas aeruginosa*, *Staphylococcus aureus*, and *Streptococcus hemolyticus* must not be detectable.

Toxicological Safety: Depending on the intended use and contact area of the product, corresponding toxicological tests are conducted. Products intended for use by pregnant women and infants must undergo skin sensitization tests, and skin irritation tests and eye irritation tests must show no irritation, with no skin sensitization observed.

Limits of Harmful Substances: The content of harmful substances such as migratable fluorescent whitening agents, lead, arsenic, and mercury in the product is tested to ensure compliance with standard limit requirements. Migratable fluorescent whitening agents must not be detectable.

Certification Process

The certification of disposable antimicrobial sanitary products typically involves the following stages:

Application Submission: Submit the application form, business license, product technical description, antibacterial agent composition description, and other materials. The certification body conducts a preliminary review of the application materials.

Document Review and Contract Signing: After passing the preliminary review, the certification body issues a notice of acceptance to the applicant, determines the certification product units, testing items, and fee standards, and then signs the certification contract.

Product Sampling and Testing: Personnel appointed by the certification body go to the production site or finished product warehouse to conduct sampling. Samples are sent to laboratories with CNAS and CMA qualifications for testing. Test items include antibacterial performance, bacteriostatic performance, microbiological indicators, toxicological safety, limits of harmful substances, etc.

On-site Inspection: The certification body organizes experts and inspectors to conduct an on-site inspection at the production site, comprehensively evaluating the applicant's quality assurance capability and product conformity.

Rectification and Review: For non-conformities identified during the audit, the enterprise completes rectification within a specified period and submits evidence, which is then reviewed by the audit team.

Evaluation and Approval of Certification Results: After both product testing and on-site inspection are passed, the certification body conducts a comprehensive evaluation, approves the certification decision, and issues the certificate.

Post-certification Surveillance: After obtaining the certificate, regular surveillance audits are conducted to ensure that products continue to meet certification requirements. Surveillance includes factory inspections, product conformity inspections, and product surveillance testing.

Renewal Audit: Upon expiration of the certificate validity period, a renewal audit is conducted in accordance with regulations. Entities passing the renewal audit receive a new certification certificate.

Value of Certification

Ensuring Consumer Safety: Through rigorous testing of antibacterial performance, microbiological indicators, and toxicological safety, it ensures that disposable antimicrobial sanitary products do not pose harm to consumer health during use. The new standard requires that products intended for pregnant women and infants show no irritation in skin irritation and eye irritation tests, with no skin sensitization observed.

Meeting New National Standard Compliance Requirements: GB 15979-2024 "Hygienic Requirements for Disposable Sanitary Products" was officially implemented on July 1, 2025. The new version imposes stricter requirements on prohibited substances in raw materials, production water, microbiological indicators, and toxicological tests. Certification ensures that products comply with the latest mandatory standards, avoiding legal risks associated with non-compliant products.

Enhancing Product Market Competitiveness: Certified products can use the certification mark on packaging and promotional materials, creating a differentiated advantage among similar products and demonstrating antibacterial and hygienic safety performance to consumers and purchasers.

Promoting Healthy Industry Development: The establishment of the certification system provides a unified technical basis and quality evaluation standard for the disposable antimicrobial sanitary product industry, effectively regulating the use of antibacterial and bacteriostatic claims, preventing false advertising, and promoting fair market competition.