Packaging materials and systems for medical devices which are to be sterilized - Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods
1Key Takeaways
This part of the series of EN 868 provides examples of particular requirements and test methods for heat and self-sealable pouches and reels manufactured from paper complying with EN 868-3 and plastic film complying with clause 4 of this European Standard. It introduces no additional requirements to the general require…
2Expert Interpretation
An in-depth analysis of BS EN 868-5:2018, the packaging standard for terminally sterilized medical devices, covers the technical requirements, test methods, and compliance points for sealable bags and rolls constructed of porous materials and plastic films. This article analyzes the relevance of the updated standard to EN ISO 11607-1 and provides professional guidance on the selection and validation of medical packaging materials.
Analysis of the Standard's Core Content
BS EN 868-5:2018, the UK national standard, fully adopts the EN 868-5:2018 European standard, replacing the 2009 edition. This standard specifically regulates packaging systems for terminally sterilized medical devices, with a focus on sealable bags and rolls composed of porous materials and plastic film.
Material Technical Requirements
| Material Type | Compliance Basis | Key Indicators |
|---|---|---|
| Porous Materials | EN 868-2/3/6/7/9/10 | Wet Strength, Air Permeability (Except Irradiation Sterilization) |
| Plastic Film | Clause 4.2.2 | ≥2-layer composite structure, no pinholes, peel strength ≥20N/15mm |
Structural Design Specifications
- Seal Width: Total seal width ≥ 6mm (including ribbed seal design)
- Opening Structure: Must be equipped with a thumb groove (≤12mm) or a lip structure (≥1mm offset)
- Process Indicator: If the process indicator is printed, it must comply with EN ISO 11140-1 and the single area must be ≥100mm²
Performance Test Requirements
Typical Test Case: A medical device factory used the ASTM F88/F88M:2015 method to test the seal strength after steam sterilization. The results showed:
- Initial Strength: 2.3N/15mm
- Post-sterilization Strength: 1.8N/15mm
- Meets the minimum requirement of 1.5N/15mm for use in medical facilities
Analysis of Standard Evolution
Main changes compared to the 2009 version:
- Introduction of ASTM standard test methods (D882, F88/F88M)
- Clarification of the applicability with EN ISO 11607-1
- Revision of seal strength test method (Appendix D)
- Update of fiber orientation determination method (Appendix F)
Implementation Recommendations
Medical device manufacturers should focus on:
- Verification of sterilization compatibility of material combinations (refer to Appendix B)
- Determination of sealing process parameter window (temperature/pressure/time)
- Regular pinhole detection (Appendix C) and seal integrity test (Appendix E)
The standard particularly emphasizes: compliance with EN 868-5 does not automatically meet the requirements of EN ISO 11607-1 and a separate declaration of compliance is required.