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02 February 2026

ISO standards for medical devices and safety requirements

Quality, Medical, Biomaterial, LSR, Plastic, Silicone

The ISO standard for medical devices is one of the fundamental pillars for ensuring patient safety and access to international markets.

In a context where engineering plastics and silicones (LSR) are essential materials in medical applications, regulatory compliance is no longer an option but an essential requirement.

Regulatory Compliance for Plastic and Silicone Medical Devices

The use of plastics and silicones in the medical sector has become established thanks to their versatility, precision and adaptability to critical applications. However, this technical advantage comes with a direct responsibility for patient safety.

Today, manufacturers face a ‘double regulatory challenge’. To market globally, it is not enough to comply with a single regulation: it is essential to meet both European Union (MDR Regulation) and United States (FDA) requirements.

Regulatory compliance is no longer considered an administrative formality, but an integral part of product design, engineering and validation from day one. 

Decisions about materials, manufacturing and plastic and silicone (LSR) injection processes, as well as quality control, have a direct impact on the regulatory viability of the final device.

The European Regulatory Framework: Safety and Classification

The European medical device system is characterised by a comprehensive approach to safety, covering the entire product life cycle (LCA) and requiring comprehensive tracking.

Regulation (EU) 2017/745 (MDR)

The MDR Regulation is a standard in Europe and is binding law. Its scope goes far beyond initial certification, as it regulates all phases of the medical device:

  • Design and development
  • Selection of plastic materials and silicones
  • Manufacturing and injection
  • Marketing
  • Post-marketing surveillance

The MDR applies to both disposable and reusable devices, raising the requirements for technical documentation, clinical evaluation and risk control compared to the previous regulation. Directive 93/42/EEC, known as the MDD (Medical Devices Directive).

Risk Classification (MDCG 2021-24)

The MDCG 2021-24 risk classification establishes how to classify a medical device as Class I, IIa, IIb or III, a critical aspect in defining the level of regulatory requirements.

The classification depends mainly on three factors:

  • Invasiveness: whether or not the device enters the human body
  • Duration of contact: transient, short or prolonged contact
  • Active or passive function: determines whether the device interacts with the body or whether its function is structural or supportive.

The higher the risk, the greater the amount of clinical and technical evidence that must be provided, which directly influences the selection of materials and manufacturing processes.

The Future of Materials: Siloxane restrictions

From 6 June 2031, new restrictions on certain siloxanes (D4, D5 and D6) will come into force under the REACH regulation. This measure responds to both environmental and public health concerns.

Manufacturers of silicone-based medical devices must review their formulations to ensure that the levels of these compounds remain within the permitted limits to guarantee the continuity of their products on the European market.

Biological evaluation in the EU: The ISO 10993 Standard

The interaction between the material and the human body is one of the most critical aspects of medical devices made of plastic and silicone.

ISO 10993

ISO 10993 standard is a set of standards aimed at biological risk management. 

Its objective is to evaluate the possible adverse effects resulting from contact between the device and the human body, considering its intended use and the duration of contact.

Understanding the voncept of Biocompatibility

Biocompatibility means that the material must fulfil its clinical function without causing unwanted toxic, physiological or immunological effects. 

This applies not only to the material itself, but also to additives, manufacturing residues and by-products that may be released.

Critical tests for plastics and silicones

In plastic and silicone devices, the most common assessments include:

  • Cytotoxicity: cell damage
  • Sensitisation: allergic reactions
  • Irritation: local inflammatory response

In addition, the analysis of extractables and leachables, i.e. chemicals that could migrate from the material into the body during use of the device, is particularly important.

U.S. Regulatory landscape: FDA and best practices

Access to the US market requires a different approach, one that is more centralised and based on scientific evidence.

FDA (Food and Drug Administration)

In the United States, the FDA acts as the sole authority. To market a medical device, the manufacturer must demonstrate that it is safe and effective (Safety & Efficacy) through solid scientific data and validated processes.

21 CFR Part 820 (GMP-Good Manufacturing Practices)

21 CFR Part 820 regulates the Quality System Regulations, which focus not so much on the final product as on the control of the production process.

The manufacturer must demonstrate total control of the value chain:

  • Selection and traceability of raw materials
  • Plastic or silicone injection process
  • Validation of moulds and processes
  • Packaging and final control

If the process is not validated in accordance with this standard, the product may be considered ‘adulterated’, even if it functions correctly.

International Quality Management: ISO 13485

For a manufacturer of plastic or silicone medical components, ISO 13485 ensuring  the quality and safety of medical equipment and is essential in the sector.

A globally recognized standard: ISO 13485

ISO 13485 is the quality management standard recognised by most international markets, including Europe, the United States, Canada and Australia. 

Its adoption facilitates regulatory compliance and acceptance by notified bodies and health authorities.

ISO 9001 vs. ISO 13485: Key differences

The key difference between ISO 9001 and ISO 13485 is the approach:

  • ISO 9001 is focused on customer satisfaction and commitment to quality, as demonstrated by the implementation of ISO 9001 at OSFplastic.
  • ISO 13485, on the other hand, focuses on risk management and process effectiveness.

In the medical sector, the priority is not only to meet expectations, but also to ensure the safety and repeatability of the production process.

Material Biocompatibility Standard: USP Class VI

USP Class VI represents the most demanding test for raw materials. 

It is a classification of the United States Pharmacopeia (USP) applied to polymers and plastic materials. There are six classes (I to VI), with Class VI being the most stringent.

The tests include:

  • Acute systemic toxicity
  • Intracutaneous reactivity
  • Implantation test

From a practical point of view, the use of USP Class VI pre-certified materials in implants, catheters or tubes significantly reduces the risk of failure in the final device tests (ISO 10993), saving the manufacturer time and money.

Why choosing a certified partner like OSF is a strategic decision

For those responsible for quality, engineering or purchasing, the choice of supplier has a direct impact on regulatory risk and return on investment (ROI). 

Working with a partner such as OSFplastic, certified to ISO 13485 and specialising in plastic and liquid silicone injection moulding for medical devices, drastically reduces:

  • The time and cost of supplier approval
  • The risk of regulatory non-compliance
  • Friction with notified bodies or the FDA

OSF is not just a supplier. It is an industrial partner that provides confidence, traceability and regulatory rigour, speeding up approval processes and helping the final device reach the market more quickly and safely.