ISO 10993-18 Testing

Material Analysis in Medical Device Development

ISO 10993-18 - Biological evaluation of medical devices -- Part 18: Chemical characterization of materials, is the key reference standard for assessing the biocompatibility of the morphology and chemical nature of medical devices.

According to ISO 10993-1, the chemical and material risks for medical devices, delivery systems and combination devices must be defined. This can lead to a need for laboratory analysis.

A toxicity risk analysis is required for all marketed products. It might be possible to use publically known information and component supplier data to confirm low risk levels for transient or short term contact devices. In the case of drug delivery systems, it is necessary to conform to ICH, PRQI and FDA Guidelines.

MET’s analytical service helps you with your initial data gathering and material risk analysis using our material characterisation flow chart. Armed with this information, we will propose a test programme according to which service level applies to your product. The service levels are described on our extractables and leachables page.

Once all the chemical and material data is gathered, we can proceed to the Toxicological Risk Analysis (TRA) for submission. The TRA is carried out using allowable limits, Safety Concern Thresholds (SCT) and Analytical Evaluation Thresholds (AET).

Medical device materials testing services provided by MET include:

Assessment of processing residuals
Batch-to-batch verifications
ISO 10993-18 materials characterisation
Cleaning fluid analysis
Goods inwards materials identification
Measurement of extractable and leachable materials from medical devices
Measurement of extractable and leachable materials from pharmaceutical containers
Verification of process changes
USP PhysicoChemical tests
USP <381>, USP <661>, USP <232>
Food migration tests for oral products
Medical device standards which give chemical analysis requirements, such as ISO 1547 and ISO 8536

Major regulatory authorities agree that biological testing should be reduced when possible:

FDA Guidance May 1, 1995 Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing

'Some devices are made of materials that have been well-characterised, both chemically and physically, in the published literature and have a long history of safe use. For the purposes of demonstrating the substantial equivalence of such devices to other marketed products, it may not be necessary to conduct all the tests suggested in the FDA matrix of this guidance.'

EN/ISO 14971 requires that 'relevant characteristics that could affect safety are listed and, from these, possible hazards are identified. For a biological safety assessment, the first step comprises characterisation of materials. Data relating to formulations, additives, processing aids, degradation products, effects of processing, residue levels, etc. allow the chemical nature of the material(s) to be fully characterised. Toxicological hazards can be identified from a knowledge of the toxicity of the chemicals or materials listed.'

MHRA Guidance 5 EC MEDICAL DEVICES DIRECTIVES GUIDANCE ON THE BIOLOGICAL SAFETY ASSESSMENT - Updated February 2011

Biocompatibility test data should, therefore, be used to complement an assessment based on materials characterisation, rather than as a replacement for it.

It may not be necessary to perform tests suggested by the standard (ISO 10993, 2005 matrix) in all cases. Where the proposed materials have already been extensively used or tested, little or no biological testing may be necessary to judge the biological safety of the device.' Brackets added by MET.

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Extractables and Leachables Testing

Extractables and Leachables Testing

Biocompatibility

Biocompatibility

Material Analysis in Medical Device Development

Material Analysis in Medical Device Development

Toxicological Risk Analysis

Toxicological Risk Analysis