Biomedical Engineering Standards and Protocols

ISO 13485 is the international standard that outlines the requirements for a quality management system specific to the medical device industry.

The Declaration of Helsinki is a set of ethical principles that provides guidance for researchers conducting medical research involving human subjects.

ICH GCP (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice) is a harmonized standard that provides guidance on the design, conduct, and reporting of clinical trials.

GLP regulations aim to ensure the quality and integrity of non-clinical safety studies conducted for the evaluation of pharmaceuticals, medical devices, and other products.

ISO 13485 is the international standard that outlines the requirements for a quality management system specific to the medical device industry, including design and manufacturing processes.

ISO 14971 is a standard that provides guidance on the risk management process for medical devices, including identification, assessment, and control of risks.

ISO 10993 is a series of international standards that provide guidance on the biological evaluation of medical devices, including tests for cytotoxicity, genotoxicity, and implantation effects.

IEC 60601 is a series of international standards that specify safety requirements for medical electrical equipment, including electrical safety, mechanical safety, and electromagnetic compatibility.

IEC 62304 is a series of international standards that provide guidance on the software life cycle processes for medical device software, including validation.

FDA 21 CFR Part 11 regulations provide guidance on the use of electronic records and signatures in the pharmaceutical, medical device, and biologics industries.

ISO 18153 is a series of international standards that provide guidance on the design, development, and evaluation of in vitro diagnostic medical devices.

ASTM F2080 is a standard that provides guidance on the design and development of medical device packaging, including materials, testing, and labeling.

ISO 11137 is a series of international standards that provide guidance on the sterilization of medical devices, including methods such as steam sterilization, ethylene oxide sterilization, and radiation sterilization.

FDA 21 CFR Part 820 regulations provide guidance on the quality system requirements for the manufacturing of medical devices.

ISO 9241 is a series of international standards that provide guidance on the design and development of user interfaces for a variety of applications, including medical devices.