1Key Takeaways
This document specifies test methods and values for sealable bags and rolls made of porous materials complying with parts 2, 3, 6, 7, 9 or 10 of EN 868 and plastic films complying with clause 4. These sealable bags and rolls are used as sterile barrier systems and/or packaging systems and are intended to maintain the s…
2Scope / Description
This document specifies test methods and values for sealable bags and rolls made of porous materials complying with parts 2, 3, 6, 7, 9 or 10 of EN 868 and plastic films complying with clause 4. These sealable bags and rolls are used as sterile barrier systems and/or packaging systems and are intended to maintain the sterility of terminally sterilized medical devices until the point of use. In addition to the general requirements specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 specifies materials, test methods and values applicable to the products covered by this document. The materials specified in this part of EN 868 are intended for single use only.
5Citation Network
Referenced by UNE-EN 868-5:2019
ASTM F88
EN 868-2:2017
EN 868-3:2017
EN 868-6:2017
EN 868-7:2017
EN ISO 11140-1
EN ISO 11607-1:2017
ISO 8601
6Frequently Asked Questions
What is UNE-EN 868-5:2019?
UNE-EN 868-5:2019 — Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods is an international standard developed by Spanish Association for Standardization (UNE). This document specifies test methods and values for sealable bags and rolls made of porous materials complying with parts 2, 3, 6, 7, 9 or 10 of EN 868 and plastic films complying with clause 4. These sealable bags and rolls are used as sterile...
What does UNE-EN 868-5:2019 cover?
This standard covers: This document specifies test methods and values for sealable bags and rolls made of porous materials complying with parts 2, 3, 6, 7, 9 or 10 of EN 868 and plastic films complying with clause 4. These sealable bags and rolls are used as sterile barrier systems and/or packaging systems and are...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of UNE-EN 868-5:2019?
The current published version is UNE-EN 868-5:2019, published on 2019-10-09. Always check for amendments or pending revisions.
How do I purchase UNE-EN 868-5:2019?
You can purchase UNE-EN 868-5:2019 by visiting our contact page. Click "Get This Standard" to view pricing and send a purchase inquiry. Our team will respond with payment and delivery details.