Medical Device General Standards

Electrospinning and its constructs may be used in a various biomedical applications. Depending on its intended use, different international standards will apply. Most countries will require ISO 13485 compliance from the product owner and the final product assembly plant. For US, it will be GMP (Good Manufacturing Practice) certification. Since ISO 13485 is the more commonly adhered standard, this article shall focus more on its requirements.

ISO 13485 is the guidance document for the quality management system of the medical device company. This is similar to the more commonly known ISO 9001 standard except that this is specifically for medical device. It covers all aspects of the device such as product development, control documentation, risk management, traceability, complains management, labeling and manufacturing. Further, having this certificate is a requirement for registering the product under CE mark. This certification requires annual external audit from the certification body and it is the basic requirements for a medical device company.

Apart from having a quality system in place, there are other specific standards and guidelines for addressing compatibility and safety requirements for the medical device. ISO 10993 contains various parts describing test protocols relevant to medical devices. Part one of ISO 10993 describes the evaluation and testing required of a medical device that comes into direct contact with the body. The tests are listed as follows,

• Cytotoxicity
• Sensitization
• Irritation or intracutaneous reactivity
• Systemic/Acute toxicity
• Subacute and subchronic toxicity
• Genotoxicity
• Implantation
• Haemocompatibility
• Chronic toxicity
• Carcinogenicity
• Reproductive/developmental
• Biodegradation

Selection of the appropriate test is dependent on the nature of body contact (eg. skin, blood contact, bones and tissue) and duration of contact (less than 24 h, 24 h to 30 days or more than 30 days).

These tests are commonly carried out in GLP (Good Laboratory Practice) certified laboratory so that the results may be used for FDA registration. Materials claimed to be "medical grade" generally means that selected tests under ISO 10993 have been performed. For a medical device, the parts and materials need not be of "medical grade" but the final assembly needs to be verified for biocompatibility in accordance to applicable parts of ISO 10993. Further, the product used for testing shall come from a "production lot" which means it is fabricated under production condition and controls.

Where the medical device is an electrical appliance, it has to satisfy IEC 60601 requirements. This document specifies the limitation and test compliance requirements for electrical (eg. air gap and creepage distance between electrical traces on PCB), mechanical design (eg trapping zone gap, transportation tests) and materials (eg. fire rating, safety factor). Therefore, it is recommended that the engineers designing a medical electrical device be familiar with IEC 60601 requirements so that re-design (if necessary) is minimized. This document also mentions the documentation requirements for software and program used in the electrical medical device. The details of the software and program requirements are found in IEC 62304. For the 3rd edition of IEC 60601, it is necessary to establish a risk management file where compliance with many of the requirements shall be based upon. Details of the risk management are found in ISO 14971.

Table 1. Applicable standards according to medical device application

Application description	Applicable standard
Implants	ISO 13485, Medical devices - Quality management systems Note: Generally required for regulatory submission in EU and most other countries ISO 10993, Biological evaluation of medical devices Supplementary standards: ISO 14971, Medical devices - Application of risk management to medical devices Other readings: ISO 14969, Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003
Device in contact with body	ISO 13485, Medical devices - Quality management systems Note: Generally required for regulatory submission in EU and most other countries ISO 10993, Biological evaluation of medical devices Supplementary standards: ISO 14971, Medical devices - Application of risk management to medical devices Other readings: ISO 14969, Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003
Electrical device	ISO 13485, Medical devices - Quality management systems Note: Generally required for regulatory submission in EU and most other countries IEC 60601, Medical electrical equipment Supplementary standards: ISO 14971, Medical devices - Application of risk management to medical devices Other readings: ISO 14969, Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003
Program and software	ISO 13485, Medical devices - Quality management systems Note: Generally required for regulatory submission in EU and most other countries IEC 62304, Medical device software - Software life cycle processes Supplementary standards: ISO 14971, Medical devices - Application of risk management to medical devices Other readings: ISO 14969, Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003

 

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