GB/T 33355-2026Specification for the safe use of health care supplies (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part

1.Structure and Drafting Rules of Standardization Documents". Drafting. This document replaces GB/T 33355-2016 "Safety Specifications for the Use of Health Massage Equipment". Compared with GB/T 33355-2016, except for the following. Aside from structural adjustments and editorial changes, the main technical changes are as follows:

a) The scope of application has been changed from health massage equipment to health service supplies and equipment (see Chapter 1, Chapter 1 of the.2016 edition); (b) The terms and definitions for massage equipment, massage services, and massage service personnel have been removed (see the.2016 edition). 3.1~3.3);

c) The category of appliances has been removed (see Chapter 4 in the.2016 edition);

d) Service organizations have been added (see Chapter 4), and the original basic requirements and personnel training content have been adjusted and incorporated into this chapter (see the.2016 edition). Chapters 5 and 7);

e) Added personnel responsibilities (see Chapter 5);

f) Safe use and management have been added (see Chapter 6), and the original equipment requirements, operating procedures, and specifications have been adjusted and incorporated into this chapter (see.2016). (Chapters 6 and 8 of the edition)

g) Evaluation and improvement have been added (see Chapter 7). Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed by the State Administration of Traditional Chinese Medicine. This document is under the jurisdiction of the National Technical Committee on Standardization of Health Care Services (SAC/TC483). This document was drafted by: Beijing Guokang Health Service Research Institute, Ningbo Yangyu Health Technology Co., Ltd., and Jiangsu Baishuiyuan Health Management Co., Ltd. Limited Liability Company, Guangdong Jiangmen Vocational College of Traditional Chinese Medicine, New Era Health Industry (Group) Co., Ltd., Yantai New Era Health Industry Co., Ltd. Hunan University of Traditional Chinese Medicine, The First Affiliated Hospital of Nanchang University, Shanxi Ruizhi Biotechnology Co., Ltd., and Guozhen Health Technology (Beijing) Limited Liability Company, Shenzhen Yunmai Technology Co., Ltd., Jiqun Pediatric Massage Chain (Dalian) Co., Ltd., Wenzhou International Innovation Center for Optometry, Shanghai Huimin Health Management Consulting Co., Ltd., Beijing Huaxia Jiuzhou Traditional Chinese Medicine Hospital, Guangzhou Kedao Culture Media Co., Ltd., and Haozhiying Real Estate Management Group Group Co., Ltd., Hebei Provincial Institute for Drug and Medical Device Inspection, Nuobainian (Shanghai) Intelligent Technology Co., Ltd., Hengshui Delong Household Service Co., Ltd. Limited Company, Haozhonghao Health Technology Co., Ltd., Hangzhou Shuifang Technology Co., Ltd., Jiangsu Xintao Health Technology Co., Ltd., Aiyoubei Technology (Suzhou) Co., Ltd., Henan Provincial Health Products Industry Chamber of Commerce, Tianjin Hezhiyoude Technology Development Co., Ltd., Beijing Xuelian Biotechnology Co., Ltd. The company, Shanghai Xiangna Industrial Co., Ltd., and Kangfudao (Beijing) E-commerce Technology Co., Ltd. The main drafters of this document are. Liu Ling, Li Ping, Jia Liang, Liu Chao, Tan Xiaoyu, Mi Jianguo, Xing Yan, Yi Jiehan, Huang Yuhui, Kong Yunyuan, and Sun Guoqiang. Yin Junxian, Li Yan, Yang Yucheng, Xu Liangde, Wang Ning, Zhou Gang, Xie Shujiang, Pu Meihua, Li Hui, Zhang Biao, Guo Xuejiang, Chen Rongxi, Yang Guangyi, Du Chuankui, Song Zhaoying, Liu Yongli, Han Jinming, Li Dezhi, Zhang Bin, Zhao Rong, Chen Ling, Li Xiaoting, Liu Ge. The release history of this document and the document it replaces is as follows:

---First published in.2016 as GB/T 33355-2016;

---This is the first revision. Safety guidelines for the use of health care products and equipment

1 Scope

GB/T 33355-2026 is the Chinese national standard covering the devices used in health services - moxibustion and cupping equipment, heat and light devices, massage tools - with their safe operating conditions, the cleaning and disinfection between clients, and the contraindications. It replaces GB/T 33355-2016. It was issued on 28 January 2026 and has been in force since 1 August 2026, replacing GB/T 33355-2016. The document is under the responsibility of the National Administration of Traditional Chinese Medicine. This page is published from the official record of the 2026 edition; the clause text of a standard this recent is not yet in circulation, and the figures, limits and tables it contains are those of the document itself, delivered in full with the English translation.

This document specifies the responsibilities of service providers and personnel involved in the safe use of healthcare supplies and equipment, as well as their safety practices, management, evaluation, and improvement. The requirements describe the corresponding verification methods. This document applies to the use of health care service supplies and equipment (hereinafter referred to as "supplies and equipment") within health care service institutions (hereinafter referred to as "institutions"). Full usage and management.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document.

GB/T 30443 General Requirements for Healthcare Services

3 Terms and Definitions

The terms and definitions defined in GB/T 30443, as well as the following terms and definitions, apply to this document.

3.1 Various products used for healthcare services.

Note. See Appendix A for examples. [Source: GB/T 30444-2026, 3.15]

4 Service Providers

4.1 The organization shall comply with the requirements of GB/T 30443.

4.2 A management system (hereinafter referred to as "management system") that meets the needs of safe use and management of supplies and equipment shall be established and implemented.

4.3 A designated person should be responsible for the safe use and management of supplies and equipment.

4.4 At least one training session on the safe use and management of supplies and equipment should be conducted annually for relevant personnel, and records should be kept. The timing of the training... as follows:

---When new employees join the company;

---When purchasing new supplies and equipment;

---When changes to the original supplies and equipment may affect safe use and management;

---Other training required.

5 Personnel Responsibilities

5.1 Management Personnel Key management personnel should be the primary responsible persons for the safe use and management of the institution's supplies and equipment, and should be responsible for the formulation, revision, training, and implementation of management systems.