ISO 11607-1-2019 PDF

Full title and description

St ISO 11607-1-2019 — Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems. This standard defines requirements and test methods for materials and packaging systems intended to maintain device sterility from completion of the sterilization process until point of use, including basic design, performance and verification expectations for sterile barrier systems and packaging systems.

Abstract

This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and complete packaging systems used to maintain the sterility of terminally sterilized medical devices until the point of use. It is applicable to manufacturers, health‑care facilities and other organisations that place medical devices into sterile barrier systems and sterilize them. The standard excludes requirements specific to aseptic manufacture, does not itself constitute a full quality‑assurance system and does not cover packaging for transport of contaminated items for reprocessing or disposal.

General information

• Status: Published (Edition 2) — this edition was reviewed and remains current.
• Publication date: 31 January 2019 (published early 2019).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.080.30 (Sterilization; sterilized packaging).
• Edition / version: Edition 2 (2019).
• Number of pages: 44 pages.

General reference information above taken from the ISO bibliographic record for ISO 11607‑1:2019, including the standard’s status and bibliographic metadata.

Scope

ISO 11607‑1:2019 applies to materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain the sterility of medical devices that are terminally sterilized (i.e., devices placed in a sterile barrier system and then sterilized). It covers performance requirements and test methods necessary to demonstrate that packaging and barrier systems preserve sterility during handling, storage and distribution until point of use. The standard does not cover all requirements for devices manufactured aseptically, does not replace a full quality‑assurance system for manufacture, and does not apply to packaging used for transport of contaminated items for reprocessing or disposal.

Key topics and requirements

• Requirements for selection and characterisation of packaging materials (physical properties, barrier properties, compatibility with sterilization methods).
• Microbial barrier performance and test methods to demonstrate maintenance of sterility.
• Design requirements for sterile barrier systems and packaging systems to enable aseptic presentation at point of use and to minimise contamination risk during opening.
• Performance testing: physical performance, seal strength, package integrity, and stability/shelf‑life assessment.
• Traceability, documentation and labelling requirements for packaging used with sterilized medical devices.
• Interaction with forming, sealing and assembly process validation (validation of those processes is covered in ISO 11607‑2).
• Application of risk management principles (added/clarified via the 2023 amendment addressing application of risk management to packaging decisions and acceptance criteria).

Technical and testing requirements for materials and packaging systems are described in detail in the standard and supporting normative references; performance and validation of processes are treated across Part 1 (materials/performance) and Part 2 (process validation).

Typical use and users

Primary users are medical device manufacturers, contract packagers, packaging engineers, sterilization service providers, quality and regulatory affairs professionals, test laboratories and sterile services departments in healthcare facilities. Regulators, notified bodies and conformity assessment bodies consult the standard when assessing packaging systems for terminally sterilized devices. The standard is used to design packaging, select materials, define acceptance criteria and document verification and testing plans.

Related standards

ISO 11607 is a two‑part series: Part 1 (this document) and ISO 11607‑2 (Validation requirements for forming, sealing and assembly processes). ISO 11607‑1:2019 has an Amendment 1 (2023) — “Application of risk management” — which updates how risk management is applied to packaging requirements. Regional/adopted equivalents and related documents include EN ISO 11607‑1 (EU adoption) and harmonised/identical national editions; applicable AAMI/ANSI guidance and related standards such as device sterilization and reprocessing standards are commonly used alongside ISO 11607‑1.

Keywords

sterile barrier system; packaging systems; packaging materials; medical device packaging; terminal sterilization; microbial barrier; seal strength; package integrity; validation; risk management.

FAQ

Q: What is this standard?

A: ISO 11607‑1:2019 is the international standard that sets requirements and test methods for materials and packaging systems intended to maintain sterility of medical devices that are terminally sterilized.

Q: What does it cover?

A: It covers selection and characterisation of materials, required performance attributes (including microbial barrier and physical performance), test methods, labelling/traceability and design considerations to ensure aseptic presentation. It does not replace a full quality system and does not cover packaging for aseptically manufactured devices or for transport of contaminated items.

Q: Who typically uses it?

A: Medical device manufacturers, packaging designers, contract packagers, sterilization providers, test laboratories, healthcare sterile services and regulatory/conformity assessment professionals.

Q: Is it current or superseded?

A: The 2019 edition (Edition 2) is the current published edition; it was confirmed during periodic review and has an Amendment 1 published in 2023 addressing application of risk management. Users should check national adoption dates and any newer amendments or revisions before relying on the text for compliance decisions.

Q: Is it part of a series?

A: Yes — ISO 11607 is a two‑part series. Part 1 (this document) addresses materials and packaging system requirements; Part 2 addresses validation requirements for forming, sealing and assembly processes.

Q: What are the key keywords?

A: Sterile barrier system, packaging systems, packaging materials, terminal sterilization, microbial barrier, package integrity, validation, seal strength, risk management.