DB62/T 5036-2024 The technical specifications for on-site inspection of carbon ion treatment systems

Scope

This document establishes the working procedures for on-site inspections of carbon ion therapy systems and stipulates the technical requirements for such inspections. This document applies to on-site inspections of carbon ion therapy system manufacturers and users by technical inspection agencies, as well as self-inspections by manufacturers to ensure compliance with quality management standards and comparative inspections by users. Note 1: The on-site locations of carbon ion therapy systems typically include manufacturing sites, installation sites, and operation and maintenance sites. The manufacturing site is usually the registered address of the manufacturer, while the installation and operation and maintenance sites are the places where the carbon ion therapy system, as a medical device, fulfills its intended purpose in medical institutions. These are terms used to refer to the carbon ion therapy system at different stages of its life cycle. Note 2: Products of various specifications and models refer to carbon ion therapy systems that include multiple specifications and models. Note 3: Various types of inspections include registration quality management system verification and supervision inspections.

Development Information

Related Standards