Medical Standards

Standards for the Medical Device Industry



Answer your questions on Quality Management, Medical Equipment & Test Methods
  • ISO-9000 Compendium ISO 9000 Standards for Quality Management
  • 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 & 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
  • IEC-60601 Series on Medical Electrical Equipment
  • ISO-10993 Series Biological Evaluation of Medical Devices
  • UL-544 Medical & Dental Equipment
  • AAMI-TIR12 Designing, Testing, & Labeling Reusable Medical Devices for Reprocessing in Health Care
  • ISO-11137 Sterilization of Health Care Products - Requirements for Validation & Routine Control - Radiation Sterilization
  • 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-980 Graphical Symbols for Use in the Labelling of Medical Devices
  • ISO-13485 Medical devices - Quality management systems - Requirements for regulatory purposes
  • ISO-14971 Medical devices - Application of risk management to medical devices
  • BS-EN-55011 Limits & Methods of Measurement of Radio Disturbance Characteristics of Industrial, Scientific & Medical (ISM) Radio-Frequency Equipment
  • 93/42/EEC Medical Device Directive