BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES (ISO 10993-17:2002, IDT)
This Malaysian Standard specifies a method for the determination of allowable limits for substances leach able from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.
This Malaysian Standard is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).
Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This Malaysian Standard does not address the potential for exposure from such sources.
Published
• (none) / (none) / (none)
PDF
29/05/2019
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NSC 18 - Medical Devices and Facilities for Healthcare
