SIST EN 1644-2:2000

Overview

EN 1644-2:2000 (CEN) - Test methods for nonwoven compresses for medical use - Part 2: Finished compresses - defines physical and chemical tests used to evaluate finished nonwoven medical compresses. The Part 2 scope focuses on test methods applied to finished products (compresses) made from nonwoven materials to verify performance, safety and conformity with buyer or regulatory requirements.

Key topics

The standard centers on practical, laboratory-based evaluation. Core technical topics typically addressed include:

• Physical test methods for assessing finished compress performance and durability (sample preparation, test conditions and measurement procedures).
• Chemical test methods for detecting residues, contaminants or characteristics relevant to patient safety and compatibility.
• Specification of test specimens and conditioning to ensure reproducible results (how products are prepared and equilibrated before testing).
• Reporting and documentation requirements so test results are traceable, comparable and suitable for quality records and regulatory submission.
• Acceptance criteria and interpretation guidance (how to use test data to assess product conformity) - users should consult the full standard text for exact limits and procedures.

Note: this summary highlights the scope and types of requirements in EN 1644-2:2000. For specific test procedures, parameters and numerical criteria, refer to the official CEN publication or your national standards body.

Applications

EN 1644-2 is directly useful for professionals involved with medical compresses and wound-care products:

• Manufacturers - to develop quality control testing protocols for finished nonwoven compresses and demonstrate product consistency.
• Quality laboratories and test houses - to perform standardized physical and chemical testing that supports product release and compliance.
• Regulatory and compliance teams - to reference harmonized test methods when compiling technical files or CE marking evidence in jurisdictions recognizing CEN standards.
• Procurement and specification writers - to specify reproducible test methods and acceptance criteria in supplier contracts or tender documents.
• R&D and product development - to benchmark finished-product performance and assess formulation or process changes.

Related standards

• EN 1644 (series) - other parts of the EN 1644 series address related materials and stages of production; check CEN or national standard bodies for Part 1 and additional parts.
• Other CEN or ISO standards on wound dressings, nonwovens, and medical device testing may be relevant when building a comprehensive test and compliance program.

For authoritative test procedures and requirements consult the official EN 1644-2:2000 document from CEN or your national standards institute.