ISO TS 16775-2021 PDF

Full title and description

ISO/TS 16775:2021 — Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2. This Technical Specification (TS) provides informative guidance to help interpret and apply the requirements of the ISO 11607 series for packaging of terminally sterilized medical devices. It clarifies intent, illustrates acceptable methods and practical approaches, and offers recommendations for evaluation, selection and use of packaging materials, sterile barrier systems and packaging-system validation without creating new normative requirements.

Abstract

ISO/TS 16775:2021 is an informative guidance document intended for both the medical device industry and healthcare facilities. It explains and illustrates how to meet the requirements of ISO 11607-1 and ISO 11607-2 (the standards for packaging for terminally sterilized medical devices) by offering practical examples, interpretation of clauses, and recommended considerations for materials, microbial barrier, sterilization compatibility, forming/sealing process validation, sampling and test methods, documentation, labelling, storage and aseptic presentation. It does not add requirements to ISO 11607 nor is it a normative/regulatory checklist.

General information

• Status: Published
• Publication date: November 2021
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.080.30 (Sterilization of health care products)
• Edition / version: Edition 2 (2021)
• Number of pages: 143

Scope

This Technical Specification provides guidance for the application of ISO 11607-1 and ISO 11607-2. It covers guidance on evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and complete packaging systems for terminally sterilized medical devices. It also provides guidance on validation requirements for forming, sealing and assembly processes and on associated documentation, sampling and test considerations. The document is informative only and does not address package use after opening or other uses (for example transport of contaminated items) where other standards or regulations may apply.

Key topics and requirements

• Interpretation and intent of ISO 11607-1 and ISO 11607-2 clauses to improve usability and consistent application.
• Selection and evaluation of packaging materials — properties, history, traceability and compatibility with sterilization processes.
• Design and performance considerations for preformed sterile barrier systems and multi-layer sterile barrier systems (including reusable systems where applicable).
• Microbial barrier assessment and sterilization-process compatibility guidance.
• Validation guidance for forming, sealing and assembly processes (process design, acceptance criteria, IQ/OQ/PQ concepts and sampling strategies).
• Sampling plans and selection of appropriate test methods aligned to ISO 11607 requirements.
• Documentation, quality system alignment and risk-based decision making for packaging activities.
• Labelling, storage, transport and aseptic presentation/usability considerations for terminally sterilized packaging.

Typical use and users

Intended users include packaging engineers, design and development teams, quality and regulatory affairs professionals, validation and reliability engineers, sterilization specialists, procurement and supplier quality teams, and healthcare facility staff involved in sterile processing and packaging. Typical uses include interpreting ISO 11607 requirements during packaging design and validation, preparing documentation and validation protocols, selecting materials and suppliers, and developing labelling and handling procedures that support aseptic presentation.

Related standards

Primary related documents include ISO 11607-1 (Packaging for terminally sterilized medical devices — Requirements for materials, sterile barrier systems and packaging systems) and ISO 11607-2 (Packaging for terminally sterilized medical devices — Validation for forming, sealing and assembly processes). ISO/TS 16775:2014 is the withdrawn first edition replaced by the 2021 edition. The TS has been adopted in regional/national variants (for example CEN/CENELEC adoptions) and is intended to be used alongside other sterilization, test-method and medical-device quality-management standards.

Keywords

terminally sterilized, sterile barrier system, packaging validation, forming and sealing, microbial barrier, sterilization compatibility, ISO 11607, process validation, packaging materials, aseptic presentation, sampling, test methods, medical device packaging, quality management

FAQ

Q: What is this standard?

A: ISO/TS 16775:2021 is a Technical Specification that provides informative guidance on applying the requirements of ISO 11607-1 and ISO 11607-2 for packaging of terminally sterilized medical devices. It explains intent and illustrates acceptable methods but is not itself a normative requirements document.

Q: What does it cover?

A: It covers guidance on selecting and evaluating packaging materials and sterile barrier systems, design and development of packaging systems, microbial-barrier and sterilization compatibility considerations, forming/sealing/assembly process validation, sampling and test-method considerations, documentation and quality/risk management, labelling, storage/transport and aseptic presentation.

Q: Who typically uses it?

A: Packaging engineers, validation and quality teams in medical device manufacturers, sterilization specialists, supplier quality and procurement staff, and healthcare sterile-processing personnel use this TS to help interpret and implement ISO 11607 requirements.

Q: Is it current or superseded?

A: The document is the second edition, published in November 2021, and replaced the 2014 edition. As of its 2021 publication it is the current edition; users should confirm any subsequent revisions or newer editions with the relevant national standards body or ISO catalog if they need absolute up-to-the-minute confirmation.

Q: Is it part of a series?

A: Yes — ISO/TS 16775:2021 is a guidance Technical Specification intended to be used with the ISO 11607 series (primarily ISO 11607-1 and ISO 11607-2) and sits within the body of standards addressing sterilization of health care products and medical-device packaging.

Q: What are the key keywords?

A: Terminally sterilized, sterile barrier system, packaging validation, forming and sealing, microbial barrier, sterilization compatibility, aseptic presentation, ISO 11607.