What is BS EN 868‑5 – Requirements of sealable medical pouches about?
BS EN 868‑5 is the fifth part of the BS EN 868 multi-series that discusses packaging for terminally sterilized medical devices. This European standard helps its users to verify the quality of the packaging products intended for medical devices.
BS EN 868‑5 specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either BS EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4. These sealable pouches and reels are used as sterile barrier systems and/or packaging systems that are intended to maintain the sterility of terminally sterilized medical devices to the point of use.
Other than the general requirements as specified in ISO 11607‑1 and ISO 11607‑2, BS EN 868‑5 specifies materials, test methods and values that are specific to the products covered by it.
The materials specified in BS EN 868‑5 are intended for single use only.
Who is BS EN 868‑5 – Requirements of sealable medical pouches for?
BS EN 868‑5 on requirements and test methods for sealable pouches and reels of porous materials and plastic film construction intended for packaging sterilized medical devices is useful for:
- Manufacturers of medical devices
- Packaging companies that cater to the medical industry
Why should you use BS EN 868‑5 – Requirements of sealable medical pouches?
The development and construction of packaging systems for terminally sterilized medical devices is complicated and critical to patient safety.
BS EN 868‑5 improves on the quality standards set by EN ISO 11607‑1 and EN ISO 11607‑2 by providing you with test methods and requirements for specific products like sealable pouches. The test methods described in BS EN 868‑5 help you to verify whether these medical packages are durable, airtight and free from defects.
These guidelines of BS EN 868‑5 enable you to maintain sterility of the medical devices and maintain hygiene in hospital premises.
What’s changed since the last update?
BS EN 868‑5:2018 supersedes EN 868‑5:2009. The main changes between BS EN 868‑5:2018 and EN 868‑5:2009 are the following:
- Normative references have been updated
- References to ASTM standards have been added
- Changes in order to align this document with the EN ISO 11607‑ series, in particular by
- Elucidating the requirements given by EN ISO 11607‑1 as general requirements for this document
- Formulating the significance and limits of the requirements of this document with respect to the requirements given by EN ISO 11607‑1
- Various performance and marking requirements have been made clearer
- The test methods for the determination of the strength of the seal for pouches and reel material according to Annex D have been amended