ASTM Section 13 covers various standards for medical devices and services, organized across two volumes:
- Volume 13.01: Focuses on medical and surgical materials and devices, which includes a broad range of specifications such as:
- Standards for thermometers and temperature measurement devices (e.g., direct-reading liquid crystal thermometers, clinical thermometers, and infrared thermometers).
- Specifications for accessories such as probe covers for clinical thermometers.
- Guides for testing and performance criteria for medical equipment like thermometers.
- Volume 13.02: Expands to include emergency medical services, search and rescue operations, and anesthetic and respiratory equipment. It also includes standards for the performance and testing of medical devices used in critical care and emergency settings.
Some key standards in these volumes include:
- E1061 for liquid crystal forehead thermometers.
- E1104 for clinical thermometer probe covers.
- E1202 for infrared thermometers.
- E2502 for anesthetic and respiratory equipment.
These volumes provide essential guidelines to ensure medical devices meet safety, performance, and reliability standards for use in clinical and emergency healthcare settings
