ISO 10993-12:2021 Biological evaluation of medical devices —
Part 12: Sample preparation and reference materials
The standard ISO 10993-12:2021 provides guidance on the preparation of samples and reference materials for the biological evaluation of medical devices. It is applicable to all stages of the product life cycle, from design and development to post-market surveillance. This standard is intended to be used in conjunction with other standards in the ISO 10993 series.
What is ISO 10993-12:2021?
ISO 10993-12:2021 specifies requirements and provides guidance for the selection, qualification, and characterization of materials used in the manufacture of medical devices and combination products that come into contact with human tissues and body fluids.
This standard applies to all materials, including metals, polymers, ceramics, textiles, and biomaterials. These materials may be used alone or in combination with each other, and they may be used in conjunction with other medical devices or combination products.
The purpose of this standard is to ensure that materials used in medical devices are safe for their intended use. This standard does not apply to implants or to devices that are intended to be used inside the body for more than 30 days.
This standard was developed by the International Organization for Standardization (ISO) Technical Committee (TC) 210, Biological evaluation of medical devices. It is part of a series of standards on the biological evaluation of medical devices (see ISO 10993).
What are the requirements of ISO 10993-12:2021
In order to ensure the safety of medical devices, the International Organization for Standardization (ISO) has published the ISO 10993 series of standards. The most recent version of this standard is ISO 10993-12:2021, which specifies requirements for the preparation of samples and reference materials for biological evaluation.
One of the main requirements of ISO 10993-12:2021 is that all samples and reference materials must be free from contaminants that could potentially cause harm to patients or users. This includes things like bacteria, viruses, and fungi.
In addition, all samples and reference materials must be stored in a way that protects them from degradation or contamination. They must also be labeled clearly so that they can be easily identified.
Finally, all samples and reference materials must be tested for their stability and purity before they are used in any biological evaluations. This ensures that they will not cause any adverse effects during testing.
What are the benefits of ISO 10993-12:2021?
The benefits of ISO 10993-12:2021 are many and varied. This standard provides guidance on the selection of appropriate sample preparation techniques and reference materials for the biological evaluation of medical devices.
One of the key benefits of this standard is that it helps to ensure that the results of the biological evaluation are reliable. This is achieved by ensuring that the samples used in the evaluation are representative of the finished device.
Another benefit of ISO 10993-12:2021 is that it provides guidance on how to select appropriate control materials. This is important because it ensures that the results of the biological evaluation can be interpreted correctly.
Finally, this standard also provides guidance on how to store and transport samples for the purposes of the evaluation. This is important because it ensures that the samples are not compromised during transport and that they remain in good condition until they are needed for the evaluation.
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