Certification in 13795-1: 2019: everything you need to know about this essential standard
The EN 13795-1:2019 standard is a key European reference for textiles used in surgical drapes, gowns, and protective equipment in medical environments. It defines performance and safety requirements to ensure the protection of both patients and healthcare professionals during surgical procedures.
In this article, we provide a detailed explanation of what EN 13795-1:2019 certification entails, its criteria, and its importance for manufacturers and users of medical equipment.
What is the EN 13795-1:2019 standard?
The EN 13795-1:2019 standard establishes specific requirements for textiles used in surgical environments. Its primary objective is to provide effective protection against:
- Microbial contamination.
- Bodily fluids and liquids.
- Airborne particles.
It primarily applies to:
- Surgical gowns.
- Surgical drapes.
- Medical protective clothing.
This standard covers both single-use and reusable textiles.
Main Objectives of the EN 13795-1:2019 Standard
- Ensure Safety: Reduce the risk of cross-contamination between medical staff, patients, and the operating environment.
- Standardize Performance: Provide uniform requirements for all medical textiles across Europe.
- Facilitate Evaluations: Offer clear criteria for testing and certifying products.
Performance Criteria of EN 13795-1:2019
The standard evaluates textiles based on several key aspects:
1. Liquid Resistance
Textiles must prevent the penetration of bodily fluids, blood, and other liquid substances to minimize infection risks.
2. Microbial Barrier
The ability of materials to block microorganism transmission is essential for protecting both patients and medical staff.
3. Mechanical Properties
Tests assess tensile strength, tear resistance, and puncture resistance to ensure fabric durability during surgical procedures.
4. Particle Shedding
Materials must not release particles that could contaminate the surgical field.
5. Physical Properties
Breathability and fabric comfort are also considered, as they influence both performance and the well-being of medical personnel.
Classification According to EN 13795-1:2019
Medical products are classified into two main categories based on performance level:
- Standard Performance: Suitable for procedures with moderate contamination risks or short-duration surgeries.
- High Performance: Recommended for long surgeries or procedures with a high risk of exposure to bodily fluids.
Surgical drapes and gowns must clearly indicate their classification on packaging or documentation.
Testing Requirements for Certification
To be certified compliant with EN 13795-1:2019, medical textiles must undergo several rigorous tests, such as:
- Resistance to liquid penetration under hydrostatic pressure.
- Measurement of microbial load.
- Particle release testing through friction.
- Mechanical testing for tensile strength and puncture resistance.
Differences Between Single-Use and Reusable Products
The standard applies to both disposable and reusable products, but their performance is evaluated differently:
- Single-Use: These products are typically made from non-woven materials with coatings for maximum protection.
- Reusable: These textiles must maintain their protective properties after multiple washing and sterilization cycles.
Who Needs to Comply with EN 13795-1:2019?
- Manufacturers of Medical Textiles: They must test and certify their products to enter the European market.
- Distributors: They must ensure that the products they sell comply with this standard.
- Hospitals and Clinics: Buyers must verify that their equipment meets safety requirements to protect staff and patients.
Penalties for Non-Compliance
Marketing non-compliant medical products can lead to:
- Financial penalties.
- Immediate product recalls.
- Loss of trust from clients and partners.
Why is EN 13795-1:2019 Certification Important?
- For Patients: It reduces the risk of hospital-acquired infections.
- For Medical Staff: It ensures safety during procedures.
- For Manufacturers: It guarantees legal compliance and enhances product credibility.
Conclusion: A Crucial Standard for Medical Safety
The EN 13795-1:2019 certification is a cornerstone of surgical safety, ensuring high standards for medical textiles. For manufacturers, distributors, and users, this standard is essential for guaranteeing the quality and safety of products used in surgical procedures.
Looking for certified medical textiles? Explore our disposable protective suits.