BS EN ISO 10993-12:2021

What is ISO 10993-12 - Biological evaluation of medical devices about?  

The ISO 10993 series is the standard series on the biological evaluation of medical devices.

ISO 10993-12 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series. 

ISO 10993-12 addresses the following: 

• Test sample selection 
• Selection of representative portions from a medical device 
• Test sample preparation 
• Experimental controls 
• Selection of, and requirements for, reference materials 

Note: ISO 10993-12 is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells. 

Who is ISO 10993-12 - Biological evaluation of medical devices for? 

ISO 10993-12 on the biological evaluation of medical devices is useful for: 

• Manufacturers of medical devices, components, and materials 
• Biomedical laboratories  
• Quality control personnel 
• Test laboratories 
• Regulatory authorities for medical devices 

Why should you use ISO 10993-12 - Biological evaluation of medical devices? 

It is important that sample preparation methods be appropriate for both the biological evaluation methods and the materials being evaluated. Each biological test method requires the selection of materials, extraction solvents, and conditions for which ISO 10993-12 lays out sample preparation and reference materials. 

ISO 10993-12 provides you with test specifications and general requirements related to medical devices which prevent hazards and risks related to the use of medical devices that arise from changes or insufficient control in the manufacturing process. 

Medical device safety and effectiveness play a vital role in healthcare. The development, delivery, management, and use of safe and effective medical devices are critical to patient outcomes and healthcare worker safety. ISO 10993-12 guides you about biological safety related to testing sample preparation and sample selection. 

ISO 10993-12 guidelines will help you in test sample selection, selection of representative portions from a medical device, test sample preparation, experimental controls, selection of, and requirements, for reference materials, and preparation of extracts. This helps you in the proper assessment of specimen that produces reliable results and can be reproducible in any laboratory. 

What’s changed since the last update? 

BS EN ISO 10993-12:2021 supersedes ISO 10993-12:2012, which has been withdrawn. BS EN ISO 10993-12:2021 has some technical changes with respect to ISO 10993-12:2012, these include: 

• Change of scope to cover extractions only for biological evaluation tests 
• Harmonization of definitions with ISO 10993-18
• Revision of 10.3.1 extraction condition table and Annex D regarding exhaustive extraction