Overview
EN ISO 11607-2:2020/A1:2023 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management - is a CEN-adopted amendment that integrates risk management into the validation framework for packaging production processes. Approved by CEN on 12 September 2023 and published as the European version of ISO 11607-2:2019/Amd 1:2023, it supplements the existing Part 2 requirements for validating forming, sealing and assembly of sterile packaging systems (SBS).
Key topics and requirements
- Validation of forming, sealing and assembly processes: Reinforces the need for documented process development, qualification and control for packaging operations that maintain sterility until point of use.
- Application of risk management: Amendment A1 explicitly requires the application of a risk-management process across design, process development, validation, production control, change management and revalidation activities.
- Management of change and revalidation: Defines expectations for maintaining process control and for when revalidation is necessary following changes.
- Sterile barrier systems (SBS) considerations: Addresses assembly requirements for SBS, with specific clauses for reusable SBS and sterile fluid‑path SBS.
- Regulatory alignment: Annex ZA and ZB map the standard to the General Safety and Performance Requirements (GSPRs) of Regulation (EU) 2017/745 (MDR) and 2017/746 (IVDR). The amendment provides a voluntary means to demonstrate conformity with relevant GSPRs (partial coverage in several areas such as sterility protection, process validation and risk controls).
- Harmonised adoption: The amendment is adopted by CEN without modification and references EN ISO 11607‑1 for materials and SBS performance/stability requirements.
Applications and who uses it
This standard is essential for stakeholders involved in sterile medical device packaging and manufacture:
- Medical device manufacturers (packaging engineers, production managers) - to establish validated packaging processes and manage risk across production.
- Quality and regulatory affairs teams - to align packaging validation with MDR/IVDR requirements and to support conformity assessment.
- Contract packers and packaging suppliers - to demonstrate validated forming, sealing and assembly processes to OEM customers.
- Notified bodies and auditors - to assess compliance with packaging process validation and risk-management expectations.
- R&D and process validation specialists - to design robust sealing/assembly protocols and change-control strategies.
Related standards
- EN ISO 11607-1:2020/A1:2023 - materials, sterile barrier systems and packaging system performance and stability testing (normatively referenced).
- ISO/TC 198 outputs on sterilization of health care products - complementary guidance on sterilization compatibility and SBS design.
Keywords: EN ISO 11607-2:2020/A1:2023, packaging for terminally sterilized medical devices, validation requirements, forming sealing assembly, risk management, sterile barrier system, MDR 2017/745, process validation, CEN.
