Conventional medical masks are commonly used in healthcare facilities to help protect healthcare workers and patients, while reducing the risk of spreading infectious agents.

In the context of growing concerns regarding the quality and safety of medical devices, manufacturing and supplying masks that comply with applicable standards not only contributes to improving product quality but also helps build trust among customers and end users.

Let us join the ISSQ Institute Quality in exploring the requirements of TCVN 8389-1:2010 Part 1 – Conventional Medical Masks, the benefits of certification activities, and the implementation process in the article below.

Why should medical masks be certified in conformity with TCVN 8389-1:2010?

Conventional medical masks are widely used in healthcare facilities and directly impact user comfort and safety. Therefore, product quality control through assessment and certification in accordance with TCVN 8389-1:2010 has attracted increasing attention from enterprises.

• Medical masks may affect health and performance: Masks that do not meet technical requirements may cause skin irritation, fail to fit closely to the face, or reduce shielding effectiveness during use.
• Inconsistent product quality increases market risks: Defects such as lint, loose threads, weak ear loops, or appearance defects may affect product aesthetics and reliability.
• The demand for demonstrating product quality is increasing: Having evidence of conformity assessment for conventional medical mask products helps enterprises build trust with customers, partners, and healthcare users.

Certification of conventional medical masks in accordance with TCVN 8389-1:2010 not only helps enterprises demonstrate product conformity with the technical requirements of the national standard but also contributes to enhancing brand reputation, maintaining stable product quality, and improving competitiveness in the market.

What is TCVN 8389-1:2010?

TCVN 8389-1:2010 is a Vietnamese National Standard specifying technical requirements for conventional medical masks. This standard applies to both sterile and non-sterile medical masks used in healthcare facilities to help ensure product quality and suitability for their intended use.

According to TCVN 8389-1:2010, conventional medical masks are required to meet several basic requirements, including:

• The mask shall not cause skin allergies to the wearer.
• The mask surface shall be clean, free from loose threads and lint, and without visual defects.
• Ear loops shall be securely sewn at the four corners of the mask.
• The edges of the mask shall fit closely to the wearer's face.

Compliance of conventional medical mask products with the requirements of TCVN 8389-1:2010 enables enterprises to better control product quality, while providing a basis for conformity certification activities and enhancing the credibility of medical masks in the marketplace.

Benefits of Certification of Conventional Medical Masks in accordance with TCVN 8389-1:2010

Certification of conventional medical masks in accordance with TCVN 8389-1:2010 not only helps enterprises demonstrate product quality but also brings numerous benefits to manufacturing and business activities, users, and quality management in the market.

For Enterprises

• Affirm product quality: Certification provides objective evidence that products comply with the requirements of the applicable standard, thereby strengthening confidence in product quality.
• Enhance brand reputation and image: Certified products help enterprises establish a professional image and improve credibility with customers, partners, and healthcare organizations.
• Increase competitive advantages in the marketplace: Certification can serve as a distinguishing factor that enables enterprises to improve their competitiveness and expand market opportunities.
• Support stable product quality control: The certification process encourages enterprises to maintain and improve quality control activities, contributing to the consistency of product quality.

For Customers and User Organizations

• Increase confidence when selecting products: Certified products provide customers and healthcare facilities with additional assurance regarding product conformity and quality.
• Contribute to safety and comfort during use: Medical masks meeting the requirements of the standard help improve user comfort and support intended protective functions.

For Quality Management Activities

• Promote the application of standards in medical device manufacturing: Certification activities encourage enterprises to adopt and implement national standards in their production processes.
• Improve the quality of products circulating in the market: Certification contributes to enhancing the overall quality and reliability of medical masks supplied to the market.

Certification of conventional medical masks in accordance with TCVN 8389-1:2010 not only benefits enterprises but also helps protect users’ interests, promotes quality management activities, and increases the level of trust in products available in the marketplace.

Certification Process for Conventional Medical Masks in accordance with TCVN 8389-1:2010

Enterprises may carry out certification activities through an assessment process consisting of the following basic steps:

Step 1: Receive the application dossier for certification.

Step 2: Sign a scientific and technological service contract.

Step 3: Conduct surveys and assessments.

Step 4: Complete the post-assessment documentation.

Step 5: Review the dossier and issue the certificate (if compliant).

Step 6: Conduct surveillance assessments at intervals not exceeding 12 months.

Step 7: Conduct re-certification assessments after the certificate expires.

Companies seeking conformity certification for conventional medical masks in accordance with TCVN 8389-1:2010 are invited to contact the ISSQ Institute Quality via hotline (+84) 981 851 111 or email vienchatluong@issq.org.vn | tcvn@issq.org.vn for guidance and support with certification procedures.

Publication Date: 26/06/2026