Wound Care - Related International Standards

The following non-harmonised international standards are related to Wound Care for EU MDR compliance reference.

Standard	Title	Status	GSPRs	Link
EN 13795-1:2025	Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns	active	11, 14	Link
EN 13726:2023	Test methods for primary wound dressings - Aspects of absorbency, moisture vapour transmission rate, waterproofness and extensibility	active	1, 3, 5, 10	Link
ISO/TS 20721:2025	Implants for surgery - Absorbable implants - General guidelines and requirements for assessment of absorbable metallic implants	active	1, 3, 5, 10	Link
EN 1644-1:1997	Test methods for nonwoven compresses for medical use - Part 1: Nonwoven compresses, all cotton or containing cotton	active	1, 3, 5, 10	Link
EN 13795-2:2025	Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits	active	1, 3, 5, 11	Link