ISO 11607, EN 868 and GB/T 19633
Additional applicable standards:
[1] GB/T 19633‑2005, Packaging for terminally sterilized medical devices
[2] GB/T 5402‑2003, Paper and board‑Determination of air permeance (medium range)‑Gurley method
[3] ISO/DIS 22611, Clothing for protection against infectious agents — Method of test for resistance to penetration by microbiologically‑contaminated aerosols
[4] ASTM F 1980, Standard Guide for Accelerated Aging of Sterile Medical Device Packages
Die‑cut retaining insert boards secure and organize components on a flat plane. HDPE die‑cut insert boards are commonly used to protect and organize devices inside pouches and header pouches. Ideal for coiled products, die‑cut insert boards prevent items from shifting within packaging, organize multiple components in a single pouch, and enhance packaging rigidity while maintaining flexible‑packaging characteristics.
Insert card height is fully customizable, with various material options available based on device size and configuration. These inserts can be packed in flexible sterilization pouches or assembled into thermoformed medical blister boxes for kit assembly. Standard materials are natural or white HDPE in multiple thicknesses. Fast turnaround from concept to production with cost‑effective tooling. Sustainable, recyclable standard materials support short‑lead‑time requirements for sterile barrier system validation.
