What is BS EN 868-4 – Paper bags for medical devices about?
BS EN 868-4 is the fourth part of the EN 868 multi-series that discusses packaging for terminally sterilized medical devices.
BS EN 868-4 specifies test methods and values for paper bags manufactured from paper specified in BS EN 868-3, 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 ISO 11607-1 and ISO 11607-2, BS EN 868-4 specifies materials, test methods, and values specific to the products covered by it.
The materials specified in BS EN 868-4 are intended for single use only.
Who is BS EN 868-4 – Paper bags for medical devices for?
BS EN 868-4 on requirements and test methods for paper bags for storing 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 868-4 – Paper bags for 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 868‑4 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 paper bags intended for storing sterilized medical devices. The test methods described in BS EN 868‑4 help you to verify whether the paper bags meet those necessary requirements.
These guidelines of BS EN 868‑4 enable you to maintain sterility of the medical devices and maintain hygiene in hospital premises.
What’s changed since the last update?
BS EN 868-4:2017 supersedes BS EN 868-4:2009. BS EN 868-4:2017 includes some technical changes with respect to BS EN 868-4:2009. These include:
Changes in order to align this European Standard with the EN ISO 11607 series, in particular by:
- Including EN ISO 11607-2 as a normative reference
- Elucidating the requirements given by EN ISO 11607-1 and EN ISO 11607-2 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
- Amendment of test method for determination of tensile strength as given by Annex C
Providing of informative data for repeatability and reproducibility of the following test methods as per Annex D:
- Chloride content
- Sulphate content