ISO/TS 16775:2021 PDF

Overview

ISO/TS 16775:2021 - Packaging for terminally sterilized medical devices - is an informative technical specification that provides guidance on applying ISO 11607‑1 and ISO 11607‑2. It clarifies intent and illustrates methods and approaches to meet the requirements of those standards without adding new normative requirements. ISO/TS 16775:2021 is intended for the medical device industry and healthcare facilities involved with packaging, sterilization and sterile handling of terminally sterilized medical devices.

Key topics and technical scope

This guidance document helps interpret and apply requirements related to:

• Selection and evaluation of packaging materials - guidance on material properties, source, history and traceability.
• Preformed sterile barrier systems and sterile barrier systems - performance considerations, multi‑layer systems and reusable systems.
• Packaging system design and development - design inputs, design process, physical protection, and sterile fluid path considerations.
• Validation of forming, sealing and assembly processes - practical approaches for process validation and acceptance criteria.
• Microbial barrier and sterilization compatibility - ensuring package integrity and compatibility with intended sterilization methods.
• Aseptic presentation and usability evaluation - guidance for designing packaging to support aseptic presentation and user‑centred usability studies.
• Storage, transport and labelling - handling conditions, labelling system considerations and documentation needs.
• Quality and risk management - aligning packaging activities with quality systems and risk‑based decision making.

Note: ISO/TS 16775:2021 is informative only and does not create regulatory requirements nor replace ISO 11607‑1/11607‑2; it does not cover package use after opening or reuse in a contaminated transport context.

Practical applications and who uses it

ISO/TS 16775:2021 is practical for:

• Packaging engineers and design teams creating sterile packaging systems for single‑use or terminally sterilized devices.
• Sterilization engineers and validation specialists planning forming, sealing and assembly validation.
• Quality assurance and regulatory affairs professionals interpreting ISO 11607 requirements and preparing technical documentation.
• Contract packagers and CMOs responsible for production conditions, material traceability and seal integrity testing.
• Healthcare sterile processing departments seeking better understanding of packaging performance and aseptic presentation design.

Use cases include material selection, sealing process validation, documenting microbial barrier rationale, usability testing for aseptic opening, and establishing packaging families for product lines.

Related standards

• ISO 11607‑1 (Packaging for terminally sterilized medical devices - Requirements for materials, preformed sterile barrier systems and packaging systems)
• ISO 11607‑2 (Requirements for validation of the packaging process)
• ISO/TS 16775:2021 serves as guidance to apply the above standards consistently in industry practice.