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ISO 11607

Nano-Test® > Research > Standards > ISO 11607

ISO 11607

ISO 11607 is a series of standards published by the International Organisation for Standardisation (ISO) which, in two parts, defines the requirements for the packaging of medical devices that are to undergo final sterilisation and be supplied in a sterile state. At European level, it was adopted as EN ISO 11607 and published as a harmonised standard under the EU Medical Devices Regulation (MDR 2017/745) (Annex ZA).

The standard consists of two parts:

  • ISO 11607-1:2019 + A1:2023 – Packaging for terminally sterilised medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (Requirements for materials, sterile barrier systems and packaging systems)
  • ISO 11607-2:2019 + A1:2023 – Packaging for terminally sterilised medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (Validation requirements for forming, sealing and assembly processes)

Note on regulatory status: The current consolidated versions of both parts are the 2019 base text plus Amendment A1:2023. The version to be used in practice and the status of national adoption must be verified against the relevant official sources (ISO, CEN, national standards organisations) prior to submission. The extent of recognition by the FDA must also be confirmed.

Basic Concepts and Definitions

  • Sterile Barrier System (SBS): The smallest packaging unit which, following sterilisation, prevents the ingress of microorganisms and enables aseptic dispensing. It typically consists of a sterile barrier (e.g. porous TYY, paper, non-woven fabric) and an adhesive system.
  • Protective packaging: Outer packaging that protects the SBS from physical damage but does not act as a sterile barrier.
  • Packaging system: The system comprising both the SBS and the protective packaging.
  • Integrity of the sterile barrier: Maintaining the SBS’s barrier function against microorganisms.
  • Sterility until the point of use: The maintenance of sterility by the packaging system until it is opened by the user.

ISO 11607-1: Materials, SBS and packaging systems

This section sets out the performance requirements for the packaging system. Key topics:

  • Material compatibility: Compatibility with sterilisation methods (EO, gamma, electron beam, steam, dry heat, plasma, etc.); non-toxicity; biocompatibility (where applicable, in accordance with the ISO 10993 series of standards)
  • Microbial barrier effect: the SBS’s resistance to permeation by microorganisms; maintenance of its function before, during and after sterilisation
  • Physical and mechanical properties: puncture resistance, tensile strength, tear resistance, leak resistance
  • Permeability to sterilising agents: The sterilising agent (steam, EO, H₂O₂) must be able to penetrate the SBS, and residues must be sufficiently removable
  • Chemical compatibility: Compatibility of the materials and adhesives with one another and with the device; potential for migration
  • Labelling: sterilisation method, expiry date, information on reusability, manufacturer’s details
  • Conformity and stability: Maintaining performance throughout the entire shelf life (ASTM F1980, supported by accelerated ageing and real-time ageing)
  • User safety: Suitability for aseptic dispensing; how the packaging opens; release of particles and fibres

ISO 11607-2: Process validation

This section describes the validation of processes during the manufacture, bonding and assembly of the SBS and the packaging system. Key topics:

  • Process validation: Verification that the manufacturing and bonding processes consistently meet the predefined requirements
  • Operational Qualification (OQ): Definition of process parameters (temperature, pressure, time) and specification of their limit values
  • Performance Qualification (PQ): Demonstration that the process can be reproduced under real production conditions
  • Installation Qualification (IQ): Verification of the suitability of plant and equipment
  • Process control and monitoring: Continuous monitoring of temperature, pressure, time and other critical parameters; calibration
  • Criteria for revalidation: Assessment of the need for revalidation following changes to materials, equipment or processes
  • Acceptance criteria: Minimum requirements for leak-tightness, visual inspection and the integrity of the microbial barrier

Relevant test methods (ASTM and others)

ISO 11607-1 refers to ASTM and other standards for the assessment of performance requirements. Common test methods include:

  • ASTM F88 – Seal Strength of Flexible Barrier Materials: Peel Strength
  • ASTM F1929 – Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration: Dye penetration test
  • ASTM F2096 – Detection of major leaks in packaging by internal pressurisation (bubble test): Bubble emission test
  • ASTM F1140/F1140M – Burst strength of non-secured packaging: burst test
  • ASTM F2097 – Standard Guide for the Design and Evaluation of Primary Flexible Packaging for Medical Devices: Guide to Design and Evaluation
  • ASTM D4169 – Performance testing of transport containers and systems: Transport simulation
  • ASTM F1980 – Accelerated ageing of sterile barrier systems: Accelerated ageing
  • ASTM F1608 – Microbial evaluation of porous packaging materials (exposure chamber method): Microbial barrier performance
  • ASTM F2638 – Standard test method for measuring the performance of porous packaging materials by means of aerosol filtration (alternative assessment of the microbial barrier)

The key parameters reported in the study are as follows:

  • Description of the packaging system and the sterile barrier system (material, adhesive technique, configuration)
  • Sterilisation method used and its parameters
  • Data on the suitability and compatibility of materials
  • Test results on microbial barrier efficacy
  • Test results for leak-tightness and integrity (F88, F1929, F2096, F1140)
  • Physical and mechanical properties (puncture resistance, tensile strength, tear strength)
  • Process validation results (IQ/OQ/PQ) and critical process parameters
  • Shelf life and ageing data (ASTM F1980 and in real time)
  • Information on labelling and legibility
  • Measurement uncertainty and repeatability data

Why is this being done?

The ISO 11607 standard is used for the following scientific and regulatory purposes:

  • Ensuring patient safety: ensuring that medical devices supplied in a sterile state remain sterile until they reach the point of use
  • MDR compliance: Ensuring that packaging and sterility are documented in the technical documentation in accordance with the EU Medical Devices Regulation (2017/745)
  • Compliance with ISO 13485 and GMP: Control and validation of packaging processes within the framework of the quality management system
  • Integration into sterilisation validation: Comprehensive sterility assurance in accordance with ISO 11135 (EO), ISO 11137 (irradiation), ISO 17665 (steam) and ISO 14937 (other methods)
  • Process validation: Demonstration that the manufacturing and sealing processes consistently and reproducibly produce suitable packaging
  • Determination of shelf life: Scientific validation of shelf life through accelerated ageing in accordance with ASTM F1980 and real-time ageing
  • Assessment of changes to suppliers and materials: determining whether revalidation is required in the event of a change of material or supplier
  • Support with regulatory documentation: Use as evidence of packaging validation and sterility assurance for FDA 510(k), EU MDR and other applications
  • Distribution and Storage: Assessment of the impact of real-world logistical conditions using ASTM D4169 distribution simulation

ISO 11607 alone does not constitute proof of sterility assurance; sterilisation validation must be carried out in conjunction with a biological evaluation (ISO 10993) and a quality management system. The results must be interpreted in the context of the packaging system, the sterilisation process, the distribution conditions and the clinical application scenario.

At NanoTest, we carry out packaging validations and performance tests in accordance with ISO 11607-1 and ISO 11607-2 with scientific rigour, utilising our accredited laboratory facilities and quality management system.

For further information on requirements analysis, the planning of process validations, performance tests, shelf-life studies, distribution simulations and reporting processes in connection with your packaging validations and performance tests in accordance with ISO 11607-1 and ISO 11607-2, please feel free to contact NanoTest.

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