FDA Recognizes New Sterility Standards for Medical Devices

Currently the FDA recognizes 100’s of consensus standards from reputable organizations such as ISO, ANSI, AAMI, IEC, ASTM, etc. These consensus standards are used on a global basis to drive the safe and effective design and development of medical devices and their associated processes.

What Are the Three Key FDA-Recognized Standards Related to Sterility?

• • ISO 11140-1:2014 (ANSI AAMI ISO 11140-1:2014) – Sterilization of health care products – Chemical indicators – Part 1: General requirements
    • Provides general requirements and test methods for indicators showing exposure to sterilization processes by means of physical or chemical change of substances used to monitor one or more process parameters specified in a sterilization process.

• • ISO 11737-3:2023 – Sterilization of health care products – Microbiological methods – Part 3: Bacterial endotoxin testing
    • Contains the general criteria applicable in determining bacterial endotoxins on or in health care products, components or raw materials, by way of bacterial endotoxins test (BET) methods using amebocyte lysate reagents.

• • ISO 13004:2022 (ANSI AAMI ISO 13004:2022) Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD
    • This standard describes details related to the methods used for substantiating a selected sterilization dose (17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy), that achieves a sterility assurance level (SAL) of 10^-6 or less for radiation sterility method of health care products. The standard specifies a method of sterilization dose audit used to demonstrate the continued efficacy of the substantiated sterility dosage.

You can access all recognized consensus standards related to medical devices here.

_____________________________________________

MedEnvoy can assist you in navigating these FDA sterility standards and determining the applicability to your medical devices. Contact us so our regulatory team can assist you.

Learn How MedEnvoy Can Assist You:

• • US FDA Agent
  • US FDA Consulting
  • RA Consulting
  • QA Consulting