T/CPASE G035-2024 The requirements for compliance management of special equipment usage in medical institutions

Scope

Scope: This document specifies the basic requirements for the management of special equipment management institutions, personnel, and equipment in medical institutions, as well as the external environment related to equipment, safety signs, evaluation of qualified suppliers, safety and energy-saving technical files, fault and accident management, and emergency response mechanisms in medical institutions. Non-medical institutions such as health care centers, nursing homes, and medical or rehabilitation clubs that use special equipment may refer to this document for implementation. This document applies to the compliance management requirements for boilers, pressure vessels, pressure pipelines, elevators, and lifting machinery, as well as safety accessories (Note) used in medical institutions. The list of special equipment involved is provided in Appendix A. The management of other equipment not covered by special equipment may also refer to this document for guidance. Main technical content: 1. Standard structure and framework: The standard format follows the provisions of GB/T 1.1–2020 "Guide for Standardization Work – Part 1: Structure and Drafting Rules for Standard Documents". The main framework structure includes: a main body (11 chapters) plus 9 appendices. The main content of the main body includes: scope, normative references, terms and definitions, general principles, equipment management, external environment related to equipment, safety signs, evaluation of qualified suppliers, safety and energy-saving technical files, fault and accident management, and emergency response mechanisms. 2. Scope: It clarifies the applicable scope and types of special equipment involved. This document applies to the relevant management work involving the use of special equipment in medical institutions. Non-medical institutions such as health care centers, nursing homes, and medical or rehabilitation clubs that use special equipment may also refer to this document for use. 3

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