EN 13795-3:2006/FprA1

Overview

EN 13795-3:2006/FprA1 is a European standard developed by CEN (European Committee for Standardization) that specifies performance requirements and performance levels for surgical drapes, gowns, and clean air suits used as medical devices. These products are intended for use by patients, clinical staff, and equipment within healthcare settings. This standard, part 3 of the series EN 13795, serves to harmonize safety and quality criteria to ensure effective infection control and protection during surgical procedures.

This document supports compliance with the EU Directive 93/42/EEC on Medical Devices, facilitating conformity assessment for manufacturers and regulators across European member states and EFTA countries. It complements EN 13795-1 and EN 13795-2 by focusing specifically on performance characteristics required for protective medical textile products in surgical environments.

Key Topics

• Performance Requirements: Defines critical criteria such as barrier efficiency, durability, strength, and resistance to liquid and microbial penetration to ensure reliable protection during surgical operations.
• Performance Levels: Establishes classification levels allowing manufacturers and healthcare providers to select appropriate medical textiles based on the risk and type of surgical procedures.
• Compliance with EU Directive: Aligns with the essential requirements of medical device regulations under Directive 93/42/EEC, ensuring these products meet health and safety standards.
• Dual-use Considerations: Addresses cases where medical protective apparel may also serve as personal protective equipment (PPE), highlighting the interplay between medical device standards and PPE directives (Directive 89/686/EEC).
• Standard Harmonization: Supports unification of surgical textile quality assessment across European countries, promoting interconnected national standards and simplifying regulatory processes.

Applications

• Healthcare Facilities: Surgical drapes, gowns, and clean air suits that meet EN 13795-3 performance levels are employed in hospitals, clinics, and surgical centers to reduce infection risks for patients and staff.
• Medical Device Manufacturers: Provides a clear framework for designing, testing, and certifying medical apparel to conform with European regulatory expectations.
• Infection Control Programs: Enables clinical safety teams to select textiles that meet appropriate barrier and protection standards for different procedural needs.
• Regulatory Compliance: Assists notified bodies and regulatory authorities in assessing conformity of surgical drapes and gowns as medical devices, facilitating market access and safety assurance.
• Cross-sector Safety: Supports healthcare professionals who require dual-function apparel serving both sterile medical environments and personal protective equipment applications.

Related Standards

• EN 13795-1: Describes general requirements and test methods for surgical drapes, gowns, and clean air suits.
• EN 13795-2: Specifies performance requirements for materials used in manufacturing surgical drapes and gowns.
• Directive 93/42/EEC: EU legislation regulating medical devices, under which this standard provides harmonized compliance.
• Directive 89/686/EEC: European PPE directive relevant for protective apparel with dual-use classification.
• ISO Standards for Medical Textiles: Other international standards complement EN 13795 series to ensure global best practices in surgical textile performance.

By adhering to the EN 13795-3:2006/FprA1 standard, medical textile producers and healthcare providers can ensure high-quality surgical drapes and gowns that deliver effective protection, contribute to patient safety, and meet stringent European regulatory requirements. This fosters confidence in surgical environments, helping reduce healthcare-associated infections and improve overall clinical outcomes.