What is BS EN 868-3 - Packaging for terminally sterilized medical devices about?
BS EN 868-3 is the third part of the EN 868 multi-series that discusses packaging for terminally sterilized medical devices.
BS EN 868-3 specifies test methods and values for paper, used in the manufacture of paper bags (specified in BS EN 868-4) and in the manufacture of pouches and reels (specified in BS EN 868-5) used as 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 868-3 specifies materials, test methods, and values specific to the products covered by it.
The materials specified in BS EN 868-3 are intended for single use only.
Who is BS EN 868-3 - Packaging for terminally sterilized medical devices for?
BS EN 868-3 on requirements and test methods for packaging for terminally sterilized medical devices 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 868-3 - Packaging for terminally sterilized medical devices?
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 868‑3 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 the paper that will be used for paper bags, pouches, and reels which are used for storing medical devices. The test methods described in BS EN 868‑3 help you to verify whether the paper meets those necessary requirements.
These guidelines of BS EN 868‑3 enable you to maintain sterility of the medical devices and maintain hygiene in hospital premises.
What’s changed since the last update?
BS EN 868-3:2017 supersedes BS EN 868-3:2009. BS EN 868-3:2017 includes some technical changes with respect to BS EN 868-3:2009. These include:
The test method on fluorescence is in accordance with ISO 2470-2. The test method according Annex B has been deleted Requirements on labelling have been clarifiedChanges in order to align this European Standard with the EN ISO 11607 series, in particular by:
- 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
