Standards for the Medical Device Industry

IEC-80002-1 Medical Device software - Part 1: Guidance on the application of ISO 14971 to medical device software
IEC-62354 General testing procedures for medical electrical equipment
IEC-60601 Series on Medical Electrical Equipment
ISO-10993 Series Biological Evaluation of Medical Devices
ISO-13485 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO/TR 14969 Medical Devices - Quality management systems guidance on the application of ISO 13485
ISO-14971 Medical devices - Application of risk management to medical devices
ISO-11137-1 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO-11137-2 Sterilization of health care products - Radiation -Part 2: Establishing the sterilization dose
ISO-11137-3 Sterilization of health care products - Radiation -Part 3: Guidance on dosimetric aspects
ISO-11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO-11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO-11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Estimation of population of microorganisms on products
ISO-11737-2 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS-EN-556-1 Sterilization Of Medical Devices. Requirements For Medical Devices To Be Designated Sterile. Requirements For Terminally Sterilized Medical Devices
BS-EN-980 Symbols for use in the labelling of medical devices
BS-EN-55011 Limits & Methods of Measurement of Radio Disturbance Characteristics of Industrial, Scientific & Medical (ISM) Radio-Frequency Equipment
AAMI-ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
AAMI-TIR12 Designing, Testing, & Labeling Reusable Medical Devices for Reprocessing in Health Care
AAMI-HE75 Human Factors Engineering - Design of Medical Devices
UL-60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety
NFPA-99 Health Care Facilities Code
93/42/EEC Medical Device Directive
93/42/EEC Harmonized Standards List The Complete List of Harmonized Standards for the Medical Device Directive
ISO-9000 Quality Standards ISO 9000 Standards for Quality Management
ASTM Standards on Surgical Implants ASTM Standards on Surgical Implants
ASQ-Z1.4 Sampling Procedures and Tables for Inspection by Attributes
ASQ-Z1.9 Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
ANSI-Z540.3 Requirements for the Calibration of Measuring and Test Equipment
IEC-61025 Fault Tree Analysis (FTA)
ISO-14644-1 Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness
ISO-14644-2 Cleanrooms and associated controlled environments -- Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1