New Standards & Regulations hub goes live

Key Takeaways

The new Standards & Regulations hub gathers the frameworks that govern sterile and medical packaging into one place.
It covers ISO 11607-1 and -2, EU MDR 2017/745, EU IVDR 2017/746, and the FDA quality-system requirements for medical devices.
It also explains the ASTM and EN test methods most often cited in regulatory submissions — seal strength, leak detection, and accelerated aging.
Each guide states the scope in plain language and points to the relevant clauses and test methods rather than reproducing the standard.
The hub is presented as a blog so new guidance can be added and dated as regulations evolve.

InnovaPax has published a dedicated Standards & Regulations hub covering the frameworks that govern sterile and medical packaging. Regulatory content is now separated from general reference material so that engineers and quality professionals can find compliance guidance quickly — and see when each piece was last updated. This article outlines what the hub covers, from ISO 11607 through the EU and FDA frameworks to the ASTM and EN test methods behind them.

Why a dedicated standards hub
ISO 11607: the core standard
EU MDR and IVDR
FDA quality-system requirements
Test methods: ASTM and EN
How to use the hub
Industry insight
Frequently asked questions

Why a dedicated standards hub

Sterile and medical packaging sits inside a dense regulatory framework. A single sterile barrier system may need to satisfy an international packaging standard, a regional medical-device regulation, and a set of validated test methods — each maintained by a different body and revised on its own schedule. Scattering that guidance across general articles makes it hard to find and hard to keep current. The hub consolidates it, and because it is structured as a dated blog, updates are transparent.

ISO 11607: the core standard

ISO 11607 is the internationally recognised standard for packaging of terminally sterilised medical devices, and it is split into two parts.

ISO 11607-1 — materials and design

Part 1 sets the requirements for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems. It defines what a sterile barrier system must achieve: microbial barrier, compatibility with the sterilisation process, and integrity maintained to the point of use.

ISO 11607-2 — validation of processes

Part 2 covers validation of the forming, sealing, and assembly processes. It is the basis for the installation, operational, and performance qualification (IQ/OQ/PQ) work that demonstrates a packaging process consistently produces an intact sterile barrier.

EU MDR and IVDR

Medical Device Regulation (EU) 2017/745

The MDR governs medical devices placed on the EU market and applied from 26 May 2021. Its general safety and performance requirements include that the device’s packaging maintain the required condition — including sterility — under the stated transport and storage conditions.

In Vitro Diagnostic Regulation (EU) 2017/746

The IVDR applied from 26 May 2022 and imposes parallel packaging and labelling expectations for in vitro diagnostic devices.

FDA quality-system requirements

In the United States, medical-device packaging falls under the FDA’s quality-system framework. The long-standing Quality System Regulation (21 CFR Part 820) is being harmonised with ISO 13485 under the Quality Management System Regulation (QMSR), which takes effect in 2026. Packaging and labelling controls, design validation, and process validation are all in scope.

Test methods: ASTM and EN

Regulatory submissions rely on standardised test methods to demonstrate seal strength, integrity, and shelf life.

Seal strength and integrity

ASTM F88 measures seal strength (peel), ASTM F1929 detects channel leaks by dye penetration, and ASTM F2096 uses internal pressurisation (bubble test) to find gross leaks.

Shelf life

ASTM F1980 provides the accelerated aging protocol used to support shelf-life claims, which must ultimately be confirmed by real-time aging.

European material standards

The EN 868 series specifies requirements and test methods for materials and systems used in the packaging of medical devices to be sterilised, complementing ISO 11607.

How to use the hub

Each guide in the hub explains a standard’s scope in plain language, identifies which clauses and test methods matter in practice, and links to related material elsewhere in the library. It is a starting point and an orientation layer — not a substitute for the official standards, which should always be obtained from the issuing body.

Industry insight

Standards are rarely the bottleneck on their own — the difficulty is understanding how ISO 11607, a regional medical-device regulation, and a stack of ASTM test methods fit together for one specific product. A hub that maps those relationships saves more time than any individual guide.

Frequently asked questions

Is ISO 11607 mandatory?

ISO 11607 is a voluntary international standard, but conformity is widely expected and is commonly used to demonstrate compliance with the packaging requirements of regulations such as the EU MDR.

What is the difference between ISO 11607-1 and -2?

Part 1 covers materials and design requirements for the sterile barrier system; Part 2 covers validation of the processes that make it.

Does the hub replace the official standards?

No. It orients you and explains scope, but the authoritative text must be obtained from the issuing body.

How often is the hub updated?

It is structured as a dated blog so new and revised guidance can be added transparently as regulations evolve.

Explore the full Standards & Regulations hub, or see the Knowledge Base for the materials and technologies these standards apply to. Official standards are available from the International Organization for Standardization.