What is BS EN 868-2 – Sterilization wraps about?
BS EN 868-2 is the second part of the EN 868 multi-series that discusses packaging for terminally sterilized medical devices.
BS EN 868-2 specifies test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, BS EN 868-2 specifies materials, test methods, and values specific to the products covered by it. The materials specified in BS EN 868-2 are intended for both single use and reuse.
Who is BS EN 868-2 – Sterilization wraps for?
BS EN 868-2 on requirements and test methods for sterilization wraps is useful for:
- Manufacturers of medical devices
- Manufacturers of packaging materials and packaging systems for sterile devices
- Healthcare facilities with in-house or contractual sterilization services
Why should you use BS EN 868-2 – Sterilization wraps?
The development and construction of packaging systems for terminally sterilized medical devices is complicated and critical to patient safety. These packaging systems need to meet certain requirements to be suitable for packaging medical devices.
BS EN 868‑2 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 sterilization wraps. The test methods described in BS EN 868‑2 help you to verify whether the sterilization wraps meet those necessary requirements.
These guidelines of BS EN 868‑2 enable you to maintain sterility of the medical devices and maintain hygiene in hospital premises.
What’s changed since the last update?
BS EN 868-2:2017 supersedes BS EN 868-2:2009. BS EN 868-2:2017 includes some technical changes with respect to BS EN 868-2:2009. These include:
Changes in order to align this European Standard with the EN ISO 11607 series, in particular by:
- Adopting terms and definitions of EN ISO 11607 series without additional elements, i.e. deleting “sterile field” and “surgical drape” which are covered by the EN 13795 series
- Elucidating the requirements given by EN ISO 11607-1 as general requirements for this standard
- Formulating the significance and limits of the requirements of this standard with respect to the requirements given by EN ISO 11607-1
- Linking the test methods with regard to information on statement of precision and bias, repeatability and reproducibility to EN ISO 11607-1:2009+A1:2014, Table B.1
The test method on fluorescence is in accordance with ISO 2470-2. The test method according Annex B has been deleted