REGULATORY TESTING OF MEDICAL GRADE PLASTICS, RUBBERS & PACKAGING MATERIALS

7. Stability testing of Raw Material / Components of Medical device (As per ISO & ASTM standards)

The medical devices stability testing is the extent to which a device holds-on, within specified limits, and throughout its period of storage and use, the same properties, and characteristics that it possessed at its time of manufacture.

Similar to pharmaceutical products, medical devices have a set of criteria to evaluate stability such as Chemical (Degradation, Interaction, Device packaging and interaction, Radioactive decay, Manufacturing), Physical (Physical characteristics, Manufacturing process, Storage conditions), Microbiological (Sterility, Environmental control, Antimicrobial effectiveness), Therapeutic, Toxicological, Biocompatibility Testing.

Zones of stability testing are Accelerated stability study (ASTM F1980, ASTM D7160), Real Time stability study (ASTM F1980, ASTM D7160) and Transport stability testing / shipment system performance testing (ASTM D4169).

8. Electrical testing of Raw Material of Medical device (As per IEC & ASTM standards)

The International Organization for Standardization (ISO) and the International Electro-technical Commission (IEC) organizations based in Europe provide standards worldwide in partnership with the World Trade Organization. These include standards for electro-medical equipment. There are general and specific standards for medical device electrical safety. IEC 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment. The primary standard governing medical device design is formally known as IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.

ASTM is one of the leading standards developers for medical devices. With 24 categories, addressing everything from surgical implements to automated analysis, ASTM medical device standards cover a truly wide range.

Electrical testing of raw materials includes Dielectric Constant/Dissipation Factor, Power Factor (ASTM D150, IEC 60250), Dielectric Strength (ASTM D149, IEC 243-1, IEC 60243), Volume Resistivity (ASTM D257, IEC 60093) and Surface Resistivity (ASTM D257, IEC 60093).

All above types of testing are schematically represented in Figure-1.

Conclusion:

After the enactment of Indian MDR, 2017 Act, CDSCO has frequently published various notifications to cover up 24 broad category of medical devices, which include approximate 2500+ devices, which are as of now not notified and have not regulated. CDSCO has given transition period till 30.09.2022 to all such class A & B devices (includes their raw materials) and till upto 30.09.2023 to all class C & D devices (includes their raw materials), after which any manufacturer of raw material as well as finished medical devices have to comply Indian MDR Rules, 2017 by doing all above mentioned testing.

References

1. Steps to be followed by the manufacturers/ importers for registration of non-notified medical devices. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_i=NzcwMQ==

2. Classification of non-notified medical devices – reg. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_i=NjQ1MA==.