YY/T 1934-2025 English PDF

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YY/T 1934-2025: Human factors design requirement and evaluation methods of orthopedic implants and surgical instruments
Status: Valid

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Basic data

Standard ID: YY/T 1934-2025 (YY/T1934-2025)
Description (Translated English): Human factors design requirement and evaluation methods of orthopedic implants and surgical instruments
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 22,241
Date of Issue: 2025-02-26
Date of Implementation: 2026-03-01
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the terms and definitions, human factors design requirements, human factors evaluation methods, etc. for human factors design and evaluation of orthopedic implants and orthopedic surgical instruments. This standard applies to orthopedic implants and surgical instruments.

YY/T 1934-2025: Human factors design requirement and evaluation methods of orthopedic implants and surgical instruments

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.40 CCSC35 Pharmaceutical Industry Standards of the People's Republic of China Human factors design requirements and Evaluation Method Released on 2025-02-26 2026-03-01 Implementation The State Drug Administration issued

Table of contents

Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 General requirements for human factor design 1 5 Detailed requirements for human factors design 2 6 Human Factors Assessment 4 Appendix A (Informative) Human Factors Design of Orthopedic Implant Boxes/Orthopedic Surgical Instrument Boxes 9 Appendix B (Informative) Subjective Questionnaire (Example. Intramedullary Nail Surgical Instrument Satisfaction Questionnaire) 10 Reference 17

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110). This document was drafted by. Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Fule Technology Development Co., Ltd., National Medical Products Administration Medical Device Technology Review Center, National Medical Products Administration Medical Device Technology Review Center The Greater Bay Area Center, Peking University Shougang Hospital, Peking University First Hospital, Tongji Hospital Affiliated to Huazhong University of Science and Technology, Yunnan Province First Hospital People's Hospital, Tianjin Hospital, the Fourth Medical Center of the General Hospital of the Chinese People's Liberation Army, Shanghai Changzheng Hospital, Affiliated Hospital of Zhejiang University School of Medicine Run Run Shaw Hospital, Qilu Hospital of Shandong University, First Affiliated Hospital of Xinjiang Medical University, Shengjing Hospital of China Medical University, Inner Mongolia Medical University The Second Affiliated Hospital of Beijing University, Beijing Jishuitan Hospital, and Beijing Lidakang Technology Co., Ltd. The main drafters of this document are. Zhao Yu, Wang Li, Jing Ming, Hu Huanyu, Zhang Jiazhen, Shen Hainan, Guan Zhenpeng, Cao Yongping, Xiao Jun, Lu Sheng, Yang Qiang, Zhang Lihai, Chen Huajiang, Xiangfangqian, Liu Xinyu, Sheng Weibin, Li Lei, Zhao Yan, Sun Zhijian, Li Wenjing, Zhai Jiliang, Qi Jianli, Ma Shuqin, Li Xiaoyun, Zhang Yidan and Zhao Binghui. Human factors design requirements and Evaluation Method

1 Scope

This document specifies the human factors design and evaluation of orthopedic implants and orthopedic surgical instruments (hereinafter referred to as "orthopedic implants and surgical instruments"). Terms and definitions, human factors design requirements, human factors assessment methods, etc. This document applies to orthopedic implants and surgical instruments. Note. For the human factors design requirements for orthopedic implant boxes/surgical instrument boxes, see Appendix A.

2 Normative references

This document has no normative references.

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Orthopedic implants Implanted in whole or in part by surgery (permanent or temporary) to assist in the repair of bones/related tissues, temporarily Or a medical device that permanently replaces the function of bone/related tissue. 3.2 Orthopedic surgical instrumentssurgicalinstruments Medical devices that participate in and assist the process of orthopedic implants being placed into the human body during surgery. 3.3 Human factors design Through the study of human behavior needs, functional needs, and operational capabilities, we can rationally design orthopedic implants and surgical instruments. Design, so as to achieve the purpose of functional recovery, safety, comfort and efficiency. 3.4 Perform validation testing of human factors design for orthopedic implants and surgical instruments.

4 General requirements for human factors design

4.1 General requirements for human factors design of orthopedic implants The general requirements for human factors design of orthopedic implants are as follows. a) Osteosynthesis implants should be compatible with the patient’s bone tissue structure; b) Spinal implants should be compatible with the patient's spinal tissue structure; ......

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