GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices

Scope

This part of GB 18278 specifies the requirements for the development, validation, and routine control of wet heat sterilization of medical devices.
Note: Although the scope of this part is limited to medical devices, the requirements and guidelines it stipulates can be applied to other health-related products.
This part includes the following wet heat sterilization processes, but is not limited to them:
a) saturated steam gravity exhaust system;
b) saturated steam power exhaust system;
c) air-steam mixed gas;
d) water spraying;
e) water immersion.

Development Information

Replace the following standards

Referenced Standards

Adopt standards

Related Standards