Testing Surgical Textiles and Clothing

Performance Validation for Global Medical Device Compliance

Surgical gowns, drapes, and cleanroom garments used in healthcare environments must demonstrate reliable barrier performance, microbial cleanliness and mechanical durability to reduce the transmission of infectious agents during surgical and other invasive procedures.

Hohenstein provides accredited laboratory testing and technical consulting aligned with internationally recognized EN and ISO standards.

EN 13795-1:2019 — Single-use and reusable surgical drapes and gowns for use as medical devices
EN 13795-2 — Cleanroom garments
Relevant ISO and ASTM test methods

Our testing supports regulatory submissions, technical claims and product performance classification for medical devices.

Standards & Regulatory Alignment

Surgical Gowns and Drapes

EN 13795-1:2019 — Surgical Gowns and Drapes

EN 13795-1:2019 defines performance requirements and test methods for single-use and reusable surgical gowns and drapes used as medical devices.

The standard addresses:

ISO 22610 — Resistance to microbial penetration (wet condition)
ISO 22612 — Resistance to microbial penetration (dry condition)
ISO 811 — Resistance to liquid penetration (hydrostatic pressure)
ISO 13938-2/ISO 29073-3 — Mechanical strength and durability (bursting and tensile strength)
EN ISO 9073-10 — Particle release (cleanliness/linting)
EN 13795-1:2019 — Classification as standard or high performance based on clinical risk areas

Testing data supports conformity assessment under the EU Medical Device Regulation (MDR 2017/745) and global market access strategies.

EN 13795 differs from EN 14126 (Protective Clothing Against Infective Agents), which applies to PPE intended for protection against high-risk biological hazards such as blood-borne pathogens and infectious aerosols.

EN 14126 — PPE Against Infectious Agents

Cleanroom Garments

EN 13795-2 — Cleanroom Garments for Surgical Environments

DIN EN 13795-2 defines performance requirements and test methods for cleanroom garments used in controlled surgical environments to limit particulate and microbial contamination in designated clean zones.

Requirements address:

ISO 9073-10 — Particle release from garment materials (linting)
ISO 22610 — Resistance to microbial contamination due to mechanical contact
ISO 22612 — Resistance to microbial penetration (dry condition)
ISO 13938-2 / ISO 29073-3 — Material integrity and mechanical durability (bursting and tensile strength)
ISO 811 — Resistance to liquid penetration
ISO 13795-2 — Cleanliness and performance requirements for controlled surgical environments

Testing provides objective performance data to support product qualification and regulatory documentation for surgical cleanroom applications.

Infectious Agents PPE

EN 14126 — Protective Clothing Against Infective Agents

Umbrella PPE standard for the performance against biological hazards.

EN 14126 specifies performance requirements and test methods for protective clothing materials and garment constructions intended to protect against biological hazards, including blood-borne pathogens, infectious microorganisms, contaminated body fluids and biologically hazardous particles.

Requirements address:

ISO 16603 — Resistance to penetration by synthetic blood under pressure
ISO 16604 — Resistance to penetration by blood-borne pathogens using bacteriophage challenge
ISO 22610 — Resistance to penetration by contaminated liquids due to mechanical contact
ISO 22611 — Resistance to penetration by biologically contaminated aerosols
ISO 22612 — Resistance to penetration by contaminated solid particles
Garment classification may also incorporate structural and general performance requirements defined in:
- EN 14325 — Performance classification of materials; seams, joints, and laminations
- ISO 13688 — General protective clothing requirements, including labeling and manufacturer information
Related evaluations may include protective gloves against micro-organisms (ISO 374-5) and optional biocompatibility assessments such as cytotoxicity testing (ISO 10993-5)

Detail: PPE Against Infectious Agents

Biological Testing

Biological Performance Testing

Evaluates microbial cleanliness and resistance to bacterial penetration under simulated clinical conditions.

Lab technician examining cell culture samples in a sterile biosafety cabinet — Biological testing provides evidence of microbial cleanliness and resistance to germ penetration in both dry and moist conditions—essential for evaluating the biological safety of medical products.

These methods support evaluation of barrier effectiveness and contamination control performance.

ISO 22610 — Resistance to germ penetration (moist condition)
ISO 22612 — Resistance to germ penetration (dry condition)
ISO 11737-1 — Microbial cleanliness (bioburden evaluation)

Physical Testing

Physical & Mechanical Performance Testing

Assesses durability and structural integrity in both dry and wet conditions.

Lab technician performing physical strength test on surgical textile material — Mechanical testing assesses how medical device materials perform under stress, including resistance to tearing, bursting and liquid penetration—key factors in ensuring durability and functional integrity.

ISO 9073-10 — Particle release in dry condition (linting)
EN ISO 811 — Resistance to liquid penetration
ISO 13938-2* — Bursting strength (dry and wet)
*Burst testing is conducted according to ISO 13938-2 (pneumatic method). EN ISO 13938-1 indicates no significant difference in bursting strength results between hydraulic and pneumatic methods for pressures up to 800 kPa.
ISO 29073-3 — Tensile strength (dry and wet)

Downloads

Need-to-Know for Manufacturers

Regulatory & Performance Considerations for Surgical Textile Manufacturers

Surgical gowns and drapes are regulated medical devices in major global markets
EN 13795 includes microbial, mechanical and cleanliness requirements beyond basic liquid barrier performance
Reusable products require validation across intended laundering and sterilization cycles
Early-stage performance testing reduces redesign risk and supports efficient regulatory documentation
Accredited test reports strengthen technical files and conformity assessment readiness

Consult a Medical Textiles Expert

As part of Hohenstein Laboratories, with over 80 years of textile expertise, Hohenstein Medical applies scientific rigor and quality-driven practices to performance testing, chemical characterization, biocompatibility and medical device safety assessments across a broad range of device categories.

Why Hohenstein Medical?

We help you validate product performance, strengthen regulatory documentation and accelerate time to market with confidence.

ISO/IEC 17025–accredited, GLP-certified laboratory
Specialized expertise in textile-based medical devices and barrier systems
Integrated biological and mechanical performance evaluation
Test reports to support technical documentation and conformity assessment
Custom testing tailored to surgical and controlled-environment textile applications
Part of the global Hohenstein network with harmonized methods and technical alignment across regions

Partner with Hohenstein Medical