A new standard has been published - BS EN ISO 11607-3: Packaging for terminally sterilised medical devices - Requirements for process development for forming, sealing and assembly.
The new standard was published in September 2026, and is yet to be harmonised with EU MDR, but as “state of the art” in this area, we can expect it to be in due course.
Throughout, I’ll abbreviate “sterile barrier system” to SBS.
The ISO 11607 series now comprises the three parts in the table below.
| Standard | Subtitle | Focus |
|---|---|---|
| BS EN ISO 11607-1 | Requirements for materials, sterile barrier systems and packaging systems | Materials to be used for sterile barrier systems, including preformed systems |
| BS EN ISO 11607-2 | Validation requirements for forming, sealing and assembly processes | Validation of sealing processes - IQ, OQ, PQ |
| BS EN ISO 11607-3 | Requirements for process development for forming, sealing and assembly | Process development for heat sealing technologies, prior to validation |
What do we already know from 11607-1 and 11607-2?
Do these standards apply to my medical device?
The ISO 11607 series of standards apply to packaging systems (typically pouches or blister packs) that form the sterile barrier (i.e. does not let microbial contamination enter) for terminally sterilised devices. Terminally sterilised devices are those that are sterilised at the end of the manufacturing process, requiring no sterilisation by the user prior to use.
Devices falling under these standards are often surgical implants or single-use surgical instruments that are provided in a sterile state, ready for immediate use.
Reusable sterile barriers are included in the standards - but remember, this is only where devices are terminally sterilised.
ISO 11607-1: Materials and design
Refer to the standard for specific wording, but to understand the context of ISO 11607-3, let's recap the part one standard.
Part one of ISO 11607 sets up some of the basic requirements, such as the need for activities to be conducted in a quality management system (QMS) and integrated with risk management processes. It requires that the selection of test methods be justified, and that those test methods should be validated; note that Annex B of the standard usefully makes reference to a range of ASTM, EN, ISO and other standards for state of the art test methods.
Materials for a SBS or preformed SBS (that’s packaging supplied part-sealed, such as a pouch sealed on three sides) should be suitable for the purpose. Reference to the EN 868 series of standards comes in useful here.
| Standard | Packaging materials and systems for medical devices which are to be sterilised… |
|---|---|
| BS EN 868-2:2025 | Sterilisation wrap. Requirements and test methods |
| BS EN 868-3:2025 | Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5). Requirements and test methods |
| BS EN 868-4:2025 | Paper bags. Requirements and test methods |
| BS EN 868-5:1999 | Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods |
| BS EN 868-6:2025 | Paper for the manufacture of packs for medical use for sterilisation by ethylene oxide or irradiation. Requirements and test methods |
| BS EN 868-7:2025 | Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilisation by ethylene oxide or irradiation. Requirements and test methods |
| BS EN 868-8:2018 | Re-usable sterilisation containers for steam sterilisers conforming to EN 285. Requirements and test methods |
| BS EN 868-9:2000 | Uncoated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids. Requirements and test methods |
| BS EN 868-10:2018 | Adhesive coated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids. Requirements and test methods |
The part one standard also covers the need:
- For conditions for production of the material or preformed SBS to be appropriate and controlled.
- For sources of materials to be traceable.
- To allow aseptic presentation (transfer of contents into a sterile area whilst maintaining sterility of that area and the contents), and usability evaluation of this.
- To physically protect the SBS and the medical device within it.
Specific properties of the material or preformed SBS to be evaluated are: microbial barrier properties, biocompatibility, physical and chemical properties, compatibility with downstream processes (e.g. sealing), compatibility with sterilisation modes (e.g. gamma irradiation) and whether the material degrades over time.
The standard goes on to list specific requirements for materials, adhesive coated materials and preformed SBS, and requirements for reusable containers and materials. There are requirements for evaluating the performance of the SBS over time and under transport and environmental conditions (stability).
ISO 11607-2: Process validation
The part two standard deals with the need for production processes to be validated. It is not practical to test the integrity of every SBS manufactured; most integrity and seal-strength tests are destructive. Therefore, in the absence of process verification, we turn to process validation for assurance that the SBS will remain sealed under storage and transport conditions, until opened by the user, or the stated expiry date.
Again, our packaging operations need to sit within a QMS and a risk management system, and test methods shall be validated. The manufacturing processes for the SBS should be validated. Whilst this primarily means sealing processes, the standard notes that related processes such as filling, wrapping or application of tape could be relevant.
Process validation must be performed in three stages, which will be familiar to anyone who has installed new equipment in a controlled environment:
- Installation qualification (IQ). This step ensures that manufacturing equipment is installed correctly, with the right resources (e.g. electricity or pneumatics), covering numerous other topics such as safety, spare parts, and software. For our packaging, it’s important at this stage to test and understand which process variables have an impact on the process outputs, and how they can be controlled.
- Operational qualification (OQ). This step develops our understanding of the impact of the process variables on the process outputs. Through a planned, structured, and statistically valid protocol, we demonstrate that the process (e.g. thermal sealing) produces the required output at the low and high limit conditions. These are the conditions within which the process is allowed to run in normal operation.
- Performance qualification (PQ). The final step demonstrates, again through planned and structured activities, that the process produces the desired outputs at nominal conditions, with anticipated sources of variance. This stage typically requires a greater sample size to account for the sources of variance, and to demonstrate with a high level of repeatability and reliability that the process has been validated.
Risk management
Annex G of part one and Annex B of part two list requirements for risk management - bringing together a number of concepts from ISO 14971 (Application of risk management to medical devices), and making them applicable to packaging design and process validation.
ISO 11607-3
What’s new
The new standard covers process development of heat sealing equipment for forming, sealing or assembly of packaging (for terminally sterilised medical devices). Annex A of part two very briefly covered this, and I suspect that annex will be removed in the next revision of ISO 11607-2, replaced with a reference to part three.
Operational impact
Conduct your impact assessment, including getting input from your manufacturing subject matter experts. However, I suspect that the feedback will be that this is largely a formalisation of existing knowledge and practices.
Section 6 - process equivalence - may provide useful references for justifications of equivalence between alternate sealing equipment, to waive process development on the alternates. Note that the manufacturer would still need to complete process validation per ISO 11607-2 on the alternate equipment (section 6.2).
Regulatory compliance impact
Section 5.1.1 gives us an exemption for SBS that have already met ISO 11607-2; existing compliance to that standard is considered to be sufficient evidence that appropriate process development has occurred. Manufacturers therefore do not need to worry about a programme to demonstrate compliance of existing SBS retrospectively.
Ensure that your impact assessment of ISO 11607-3 is completed, and has been referenced or integrated into manufacturing development procedures, where appropriate.
How long do we have to comply with ISO 11607-3?
Regulators understand that industry needs time to respond to a new or revised standard. There is no defined timeline as to when you should comply with a new standard, so bring it back to the processes involved:
- You should have a process for detecting new standards and assessing their impact. Ensure this is functioning smoothly, with no backlog.
- The external standards process should produce an impact assessment, and a plan for compliance. Take a risk-based approach to determine and rationalise the timelines for the plan.
- Keep tabs on the progress of the plan. If an auditor asks about ISO 11607-3, having an implementation plan and progress report to hand puts you in a great position.
All that said, in my experience EU notified bodies typically look for compliance to a new standard within 3 years of publication.
If you're working through your ISO 11607-3 impact assessment, or want a second opinion on how your packaging validation evidence will read to a notified body, get in touch or book a free 25-minute “ask me anything” session. For definitions of terms not explained in this article, see my regulatory glossary.