ISO Standards

1. ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory
purposes.
2. ISO 14971 - Medical devices - Application of risk management to medical devices.
3. ISO 10993 - Biological evaluation of medical devices (Series).
IEC Standards
1. IEC 60601 - Medical electrical equipment (Series):
 IEC 60601-1 - General requirements for basic safety and essential performance.
 IEC 60601-1-2 - Electromagnetic disturbances - Requirements and tests.
 IEC 60601-1-6 - Usability.
 IEC 60601-1-8 - General requirements, tests, and guidance for alarm systems in medical
electrical equipment and medical electrical systems.
 IEC 60601-1-11 - Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment.
2. IEC 62304 - Medical device software - Software life cycle processes: This standard is crucial for
wound VAC devices that utilize software for operation, control, or monitoring.
Additional ISO Standards
4. ISO 15223-1 - Medical devices - Symbols to be used with medical device labels, labelling, and
information to be supplied - Part 1: General requirements.