BS EN ISO 10993-12:2009

BS EN ISO 10993-12:2009 Biological evaluation of medical devices. Sample preparation and reference materials

BS EN ISO 10993-12 specifies the methods of sample preparation and the selection of reference materials in the biological evaluation of medical devices.

Sample preparation methods should 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.

BS EN ISO 10993-12 is based on existing national and international specifications, regulations and standards wherever possible. It is periodically reviewed and revised.

This part of ISO 10993 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 in biological systems in accordance with one or more parts of the BS EN ISO 10993 series. Specifically Part 12 of BS EN ISO 10993 addresses:

• Test sample selection
• Selection of representative portions from a device
• Test sample preparation
• Experimental controls
• Selection of and requirements for reference materials
• Preparation of extracts.

BS EN ISO 10993-12 is not applicable to materials or devices containing live cells.

Contents of BS EN ISO 10993-12 contain

• Introduction
• Scope
• Normative references
• Terms and definitions
• General requirements
• Reference materials
• Certification of RMs for biological safety testing
• Use of RMs as experimental controls
• Test sample selection
• Test sample and RM preparation
• Selection of representative portions from a device
• Preparation of extracts of samples
• Containers for extraction
• Extraction conditions and methods
• Extraction conditions for hazard identification and risk estimation in the exaggerated-use condition
• Records
• Experimental controls
• General principles on and practices of test sample preparation and sample selection
• Principles of test sample extraction
• Bibliography

BS EN ISO 10993-12:2009 replaces BS EN ISO 10993-12:2007 which is withdrawn.