ISO 10993-1 provides a framework for a structured programme of assessment for the evaluation of biological safety. Clause 3 of ISO 10993-1:2003 states that in the selection of materials to be used for device manufacture the first consideration should be fitness for purpose. This should have regard to the characteristics and properties of the material, which include chemical, toxicological, physical, electrical, morphological and mechanical properties. This information is necessary prior to any biological evaluation. Subclause 7.2 of ISO 10993-1:2003 notes that the continuing acceptability of a biological evaluation is an aspect of a quality management system.
Also ISO 14971 points out that a toxicological risk analysis should take account of the chemical nature of the materials.
The requirements specified in this document are intended to yield the following information, which will be of value in predicting the biological response of the materials:
— The chemical composition of the materials used in the manufacturing process including processing additives and residues e.g. trace chemicals, cleaning, disinfection and testing agents, acids and caustic substances.
— The characterization of materials to be used in the production of medical devices, as well as in devices in their final form.
— Identification of the materials of construction of the medical device.
The potential of medical device materials to release substances or breakdown products due to the manufacturing process.
— Changes in the materials of construction, which result from changes in the manufacturing process or insufficient control of the manufacturing process.
The compositional characteristics of the materials of manufacture are mainly under the control of the suppliers of these materials. However other characteristics are chiefly influenced by the requirements to be met by the finished medical device as well as the processes used by the medical device manufacturer.
This part of ISO 10993 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications, for example:
As part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971).
Measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment
(ISO 10993-17).
— Judging equivalence of a proposed material to a clinically established material.
— Judging equivalence of a final device to a prototype device to check the relevance of data on the latter to be used to support the assessment of the former.
Screening of potential new materials for suitability in a medical device for a proposed clinical application.
This part of ISO 10993 does not address the identification or quantification of degradation products, which is covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.BS EN ISO 10993-18:2009 pdf free download.
The ISO 10993 series of standards is applicable when the material or device comes into contact with the body directly or indirectly (see 4.2.1 of ISO 10993-1:2003).