International Standard

ISO 13485 Medical devices- Quality management systems- Requirements for regulatory purposes

ISO 10993-1 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process

ISO 8536-4  Infusion equipment for medical use- Part 4: Infusion sets for single use, gravity feed

ISO 15223-1 Medical devices- Symbols to be used with information to be supplied by the manufacturer- Part 1: General requirements

ISO 14971 Medical devices- Application of risk management to medical devices

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