What is the ISO 10993 used for?
This blog will cover an overview of what ISO 10993 entails, why it is important for biocompatibility testing, an understanding of what it is, the most recent updates (changes from ISO 10993-1:2009 to ISO 10993 1:2018), and more.
An Overview of ISO 10993
The ISO 10993 set of Standards encompasses the systematic evaluation of biological risks of medical devices used in various classes of medical devices.
This incorporates low-risk Class 1 medical devices, such as bandages, oxygen masks and tongue depressors, to intermediate-risk Class 2 medical devices, such as pregnancy tests and contact lenses, right through to high-risk Class 3 medical devices that include deep-brain stimulators and pacemakers.
The most recent version of the Standard (ISO 10933 1:2018) comprises the following parts:
1 - Evaluation and testing within a risk management process
2 - Animal welfare requirements
3 - Tests for genotoxicity, carcinogenicity and reproductive toxicity
4 - Selection of tests for interactions with blood
5 - Tests for in vitro cytotoxicity.
6 - Tests for local effects after implantation
7 - Ethylene oxide sterilisation residuals
8 - Selection of reference materials (withdrawn)
9 - Framework for identification and quantification of potential degradation products
10 - Tests for skin sensitization
11 - Tests for systemic toxicity
12 - Sample preparation and reference materials (available in English only)
13 - Identification and quantification of degradation products from polymeric medical devices
14 - Identification and quantification of degradation products from ceramics
15 - Identification and quantification of degradation products from metals and alloys
16 - Toxicokinetic study design for degradation products and leachables
17 - Establishment of allowable limits for leachable substances
18 - Chemical characterization of medical device materials within a risk management process
19 - Physico-chemical, morphological and topographical characterisation of materials
20 - Principles and methods for immunotoxicology testing of medical devices
22 - Guidance on nanomaterials
23 - Tests for irritation
33 - Guidance on tests to evaluate genotoxicity
Implementing the Standards is particularly relevant for medical device manufacturers to ensure compliance with worldwide regulations.
The Importance of Biocompatibility Testing
The EN ISO 10993-1 (the evaluation and testing within a risk management process) is the cornerstone of the Standards series. To better understand it, it is important to first define the term biocompatibility. Biocompatibility is the ability of a medical device or material to elicit a desirable reaction in a host for a specific purpose. As such, biocompatibility testing is vital for medical devices to prevent or minimise adverse effects.
Understanding EN ISO 10993-1
The EN ISO 10993-1, which details biological risk evaluation, assesses biocompatibility along the following two metrics:
1 - The extent of contact with the body, such as whether it is topical or implanted within the body.
2 - The length of time that bodily contact with the material or device occurs (i.e. limited - up to 24 hours; prolonged -between 24 hours and 30 days; or permanent - exceeding 30 days).
The evaluation is made according to a risk-based approach, balancing the benefits of a given device against any adverse effects, both in the short and long term.
Key Changes in ISO 10993-1:2018
At the time of writing, the ISO 10993 1:2018 is the latest version of ISO 10993. It is updated from the previous version: ISO 10993-1:2009. The key changes between the two iterations are improved risk management and material categorisation. This provides medical device manufacturers with greater clarity, and the opportunity to streamline their testing processes
ISO 10993-10: Irritation and Sensitisation Testing
Another key part of this Standard is the ISO 10993-10. Its purpose is to test for potential irritation and sensitisation to the skin caused by materials from which medical devices are made. Testing occurs using the in vitro (cell) and in vivo (animal) methods to determine if using a device on human skin or tissues could provoke an allergic reaction. This can be applied to medical devices that include bandages, blood pressure cuffs, devices for blood transfusions and any device.
How ISO 10993 Ensures Regulatory Compliance
ISO 10993 helps medical device manufacturers meet necessary regulatory requirements in Australia, the European Union, the US and other major markets. As well as guiding risk assessment, adhering to the Standards can help manufacturers improve efficiencies such as gaining faster pre-market approval.
Applications of ISO 10993 in Medical Device Development
The ISO 10993 is particularly relevant to manufacturers developing devices like implants, catheters, and surgical instruments. Given the necessity for contact with the body—especially in the case of permanent implants such as pacemakers—it is crucial for patient safety that these Standards are adhered to throughout the development lifecycle of medical devices.
FAQs About ISO 10993
What is ISO 10993 used for?
ISO 10993 is a series of Standards used for assessing the biocompatibility of medical devices with the human body.
Is ISO 10993 mandatory for medical device manufacturers?
Although ISO 10993 is widely adopted as a set of biocompatibility Standards for medical devices, it is not mandatory for manufacturers to adhere to it. This said it is highly recommended for medical device manufacturers to use it.
Conclusion: The Role of ISO 10993 in Medical Device Safety
Collectively, the ISO 10993 set of Standards ensures the safety, reliability and compliance of medical devices, regardless of where they are manufactured or used throughout the world. They provide a clear framework of reference for medical device manufacturers to adhere to in order to meet regulatory process requirements and maximise the safety of patients.