Wire harnesses for medical devices
Typical requirements
Medical device applications place high demands on the biocompatibility of materials used, cleanroom assembly, and complete documentation of manufacturing steps.
Relevant standards
ISO 13485 for quality management and ISO 14971 for risk management are common. Depending on the device, electrical safety standards such as the IEC 60601 series may also apply.
Traceability
Many medical devices require end-to-end traceability of materials and manufacturing batches.
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