BS EN 868-8:2018

What is BS EN 868‑8- Requirements and test methods for re-usable sterilization containers for steam sterilizers about?

BS EN 868‑8 discusses packaging for terminally sterilized medical devices. BS EN 868‑8 is an international standard on requirements and test methods for re-usable sterilization containers for steam sterilizers to assure the sterility of the medical devices.

BS EN 868‑8 is the eighth part of the BS EN 868 series on packaging for terminally sterilized medical devices that specifies test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are intended to be used in steam sterilizers conforming to EN 285.

Other than the general requirements as specified in EN ISO 11607‑1 and EN ISO 11607‑2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by BS EN 868‑8.

Note1: The use of additional materials and/or accessories inside the sterile barrier system to ease the organization, drying, or aseptic presentation (e.g., inner wrap, indicators, packing lists, mats, instrument organizer sets, tray liners, or an additional envelope around the medical device) is not covered in EN 868-8. However, other requirements, including the determination of the acceptability of these materials and/or accessories during validation activities, can apply.

Who is BS EN 868‑8- Requirements and test methods for re-usable sterilization containers for steam sterilizers for?

BS EN 868‑8 on  requirements and test methods for re-usable sterilization containers for steam sterilizers is useful for:

• Pharmaceutical industries
• Testing laboratories/test personnel of medical devices
• Any entities involved in medical devices packaging

Why should you use BS EN 868‑8- Requirements and test methods for re-usable sterilization containers for steam sterilizers?

Packaging is an integral part of a pharmaceutical product. Medical device packaging is an important part of delivering the device to market safely and securely, with the sterile barrier intact. Poor packaging can cause safety issues to the medical device and its consumers.

BS EN 868‑8 provides you with the requirements and test methods for terminally sterilized medical devices to assure the sterility of the medical devices.

BS EN 868‑8 assists in maintaining sterility until the time of use and ensuring the medical device is safe and secure during the shelf life.

What is changed since the last update?

BS EN 868‑8:2018 supersedes EN 868‑8:2009. BS EN 868‑8:2018 has made some technical changes. These include:

• Normative references have been updated
• Changes to align this document with the EN ISO 11607 series, by elucidating the requirements given by EN ISO 11607‑1 as general requirements for BS EN 868‑8, formulating the significance and limits of the requirements of BS EN 868‑8 with respect to the requirements given by
• The term “handles” has been substituted by a broader term “carrying devices.”
• The bibliography has been updated