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GBZ40986-2021: General technical conditions for assembly of upper extremity prosthesis
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/Z 40986-2021 | English | 479 |
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General technical conditions for assembly of upper extremity prosthesis
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GB/Z 40986-2021
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Basic data | Standard ID | GB/Z 40986-2021 (GB/Z40986-2021) | | Description (Translated English) | General technical conditions for assembly of upper extremity prosthesis | | Sector / Industry | National Standard | | Classification of Chinese Standard | C45 | | Word Count Estimation | 22,269 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GBZ40986-2021: General technical conditions for assembly of upper extremity prosthesis---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.
GB /Z 40986-2021
General technical conditions for assembly of upper extremity prosthesis
ICS 11.040.40
CCSC45
National Standardization Guiding Technical Documents of the People's Republic of China
General technical conditions for assembly of upper limb prostheses
Released on 2021-11-26
2021-11-26 implementation
State Administration for Market Regulation
Issued by the National Standardization Management Committee
Table of contents
Foreword Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Category 2
5 Technical requirements 2
6 Inspection method 5
7 Inspection rules 7
8 Delivery 8
9 Marking, packaging, transportation, storage 9
Appendix A (normative) Prosthetic configuration medical record home page 10
Appendix B (Normative) Prosthesis Configuration Checklist 11
Appendix C (Normative) Prosthetic Limb Configuration Prescription 12
Appendix D (Normative) Some hand prosthetic configuration size measurement records 13
Appendix E (Normative) Measurement record of discontinued wrist prosthesis configuration size 14
Appendix F (Normative) Measurement record of forearm prosthesis configuration size 15
Appendix G (Normative) Measurement record of elbow discontinued prosthesis configuration size 16
Appendix H (Normative) Measurement record of upper arm prosthesis configuration size 17
Appendix I (Normative) Measurement record of shoulder prosthesis configuration size 18
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 of Standardization Documents"
Drafting.
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents.
This document was proposed by the Ministry of Civil Affairs of the People's Republic of China.
This document is under the jurisdiction of the National Standardization Technical Committee for Rehabilitation and Special Equipment for the Disabled (SAC/TC148).
This document was drafted by. Huaibei Feilong Disabled Prosthetics Co., Ltd., Anhui Quality and Standardization Research Institute, Ottobock (China) Engineering Co., Ltd.
Industry Co., Ltd., National Research Center for Rehabilitation Aids, Shanghai Kesheng Prosthetics Co., Ltd., Danyang Prosthetic Factory Co., Ltd., Danyang Runben Rehabilitation Appliance
Co., Ltd., Beijing Ruiha International Prosthetic Orthotics Trading Co., Ltd., Jinhua Deren Prosthetic Orthotics Rehabilitation Equipment Co., Ltd., Beijing Hui
Ci Prosthetic Medical Supplies Development Co., Ltd., Information Research Institute of Huaibei City Quality and Technical Supervision Bureau.
The main drafters of this document. Ma Haitao, Ding Changdong, Gao Tiecheng, Zhao Liwei, Luo Yongzhao, Yang Dongqing, Wu Jian, Wu Xihan, Jiang Luohui, Hou Ligang,
Wu Qian and Zhang Guangfeng.
General technical conditions for assembly of upper limb prostheses
1 Scope
This document specifies the classification, assembly technical requirements, inspection methods, inspection rules, delivery, marking, packaging, transportation and
store.
This document applies to decorative upper limb prostheses, self-powered upper limb prostheses (cable controlled upper limb prostheses), electric upper limb prostheses, and hybrid upper limb prostheses
The finished product of the limb.
2 Normative references
The content of the following documents constitutes an indispensable clause of this document through normative references in the text. Among them, dated quotations
Only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
This document.
GB/T 191 Packaging, storage and transportation pictorial signs
GB/T 1447 Test method for tensile properties of fiber reinforced plastics
GB/T 1449 Test method for bending performance of fiber reinforced plastics
GB/T 1451 Fiber-reinforced plastic simply supported beam impact toughness test method
GB/T 3768 Acoustic sound pressure method is used to determine the sound power level and sound energy level of noise sources using the simple envelope measurement surface above the reflecting surface.
Easy method
GB/T 9174 General technical requirements for general cargo transportation packaging
GB/T 14191.1 Terminology of prosthetics and orthotics-Part 1.Basic terminology of external limb prostheses and external orthoses
GB/T 18027 Electric upper limb prosthesis parts
GB 22457 Prosthesis configuration service
MZ002 Self-powered upper limb prosthesis
MZ007 Skeleton-style decorative upper limb prosthesis general parts
3 Terms and definitions
The following terms and definitions defined in GB/T 14191.1 apply to this document.
3.1
Decorative upper limb prosthesis cosmeticarm
The main purpose of decoration is the upper limb prosthesis which pays attention to the appearance and shape of the limbs.
Note. Decorative upper limb prostheses are commonly known as cosmetic hands.
3.2
Body-powered upper limb prosthesis
The movement of the upper limbs or torso is the manipulating power to control the upper limb prosthesis of special joints and hand devices.
Note. Self-powered upper limb prostheses are commonly known as cable-controlled upper limb prostheses.
3.3
Electric upper limb prosthesis electricarm
The upper-limb prosthesis using micro-motors to drive the prosthetic joints and hand devices.
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