GB/T 45265-2025 General technical requirements for additive manufacturing of lower limb prostheses English, Anglais, Englisch, Inglés, えいご
This is a draft translation for reference among interesting stakeholders. The finalized translation (passing through draft translation, self-check, revision and verification) will be delivered upon being ordered.
ICS 11.180.01; 25. 030
CCS C 45; J 39
National Standard of the People's Republic of China
GB/T 45265-2025
General technical requirements for additive manufacturing of lower limb prostheses
下肢假肢增材制造通用技术要求
(English Translation)
Issue date: 2025-02-28 Implementation date: 2025-06-01
Issued by the State Administration for Market Regulation
the Standardization Administration of the People's Republic of China
Contents
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Technical requirements
6 Test methods
Bibliography
General technical requirements for additive manufacturing of lower limb prostheses
1 Scope
This document specifies the technical requirements for additive manufacturing of lower limb prostheses and describes the corresponding test methods.
This document applies to the manufacture of sockets for lower limb prostheses of different amputation levels produced by additive manufacturing.
Note: Including sockets for hip disarticulation prostheses, thigh prostheses, knee disarticulation prostheses, calf prostheses, and Syme prostheses.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 13461 Modular calf prostheses
GB/T 14191.2 Prosthetics and orthotics - Terminology - Part 2: Terms relating to prostheses and prosthesis users
GB 14722 Modular hip, knee and thigh prostheses
GB 14723 General components for lower limb prostheses
GB/T 16432 Assistive products for rehabilitation - Classification and terminology
GB/T 35351 Additive manufacturing - Terminology
3 Terms and definitions
The terms and definitions defined in GB/T 14191.2, GB/T 16432 and GB/T 35351 as well as the following apply to this document.
3.1
data collection of lower limb stump
process of obtaining shape data of the lower limb stump using data collection tools
3.2
digital design of stump socket
process of designing a digital model of the stump socket through computer-aided design based on the collected data
3.3
additive manufacturing
process of manufacturing parts or physical objects by material accumulation based on three-dimensional model data
3.4
additive manufacturing of stump socket
process of conducting digital design of the stump socket based on lower limb stump data collection, and obtaining the stump socket using additive manufacturing technology with special additive manufacturing materials such as polymers and metals
3.5
lower limb prostheses assembled with additive manufactured stump socket
customized product delivered for use after assembling, aligning, etc., the additive manufactured stump socket with general components of lower limb prostheses and confirming the fit is qualified
3.6
surface model
mathematical or digital expression method that describes a physical object using a collection of planes and/or curved surfaces
4 Abbreviations
The following abbreviations apply to this document.
ABS: acrylonitrile-butadiene-styrene
AMF: additive manufacturing file format
CT: computed tomography
IGES: initial graphics exchange specification
MRI: magnetic resonance imaging
PA: polyamide
PETG: polyethylene terephthalate-1,4-cyclohexane dimethanol ester
PEEK: polyetheretherketone
PP: polypropylene
STL: standard triangulation language
TPU: thermoplastic urethane
5 Technical requirements
5.1 Requirements for lower limb stump data collection
5.1.1 Data collection methods
Data collection shall include but not be limited to one or more of the following methods:
a) Through 3D scanner;
b) Through CT or MRI tomography;
c) Through multi-angle photo synthesis;
d) Through fitting of discrete circumference measurements of the stump.
5.1.2 Data collection modes
Data collection shall include but not be limited to the following modes:
a) Collecting stump data: Using collection tools (including MRI) to collect data on the surface of the lower limb stump to directly obtain the digital model of the stump;
b) Collecting data of the plaster bandage negative mold: Using collection tools to collect data on the inner surface of the plaster bandage negative mold to indirectly obtain the digital model of the stump;
c) Collecting data of the plaster positive mold: Using collection tools to collect data on the surface of the plaster positive mold to indirectly obtain the digital model of the stump.
5.1.3 Process requirements for data collection
The following requirements shall be noted during the data collection process:
a) Digital collection equipment shall adopt a non-invasive acquisition method and shall not cause harm to the collector and the collected patient's human body;
b) Patient privacy shall be protected during the data collection process;
c) Appropriate positions and angles shall be selected for collection according to the patient's different conditions, the scanned part shall not be blocked, and the data collection shall be complete;
d) Collection markers shall be pasted on bony prominences and pressure-sensitive weight-bearing areas;
e) For patients with calf amputation, sagittal and frontal plane photos of the patient's seated stump and thigh area shall be taken; for patients with hip disarticulation amputation, thigh amputation, knee disarticulation amputation, and Syme amputation, sagittal and frontal plane photos of the lower body in the standing position shall be taken;
f) For complex stumps, videos may be taken;
g) According to the actual situation, the surface contour data of the stump may be collected repeatedly to analyze data differences.
GB/T 45265-2025 General technical requirements for additive manufacturing of lower limb prostheses English, Anglais, Englisch, Inglés, えいご
This is a draft translation for reference among interesting stakeholders. The finalized translation (passing through draft translation, self-check, revision and verification) will be delivered upon being ordered.
ICS 11.180.01; 25. 030
CCS C 45; J 39
National Standard of the People's Republic of China
GB/T 45265-2025
General technical requirements for additive manufacturing of lower limb prostheses
下肢假肢增材制造通用技术要求
(English Translation)
Issue date: 2025-02-28 Implementation date: 2025-06-01
Issued by the State Administration for Market Regulation
the Standardization Administration of the People's Republic of China
Contents
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Technical requirements
6 Test methods
Bibliography
General technical requirements for additive manufacturing of lower limb prostheses
1 Scope
This document specifies the technical requirements for additive manufacturing of lower limb prostheses and describes the corresponding test methods.
This document applies to the manufacture of sockets for lower limb prostheses of different amputation levels produced by additive manufacturing.
Note: Including sockets for hip disarticulation prostheses, thigh prostheses, knee disarticulation prostheses, calf prostheses, and Syme prostheses.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 13461 Modular calf prostheses
GB/T 14191.2 Prosthetics and orthotics - Terminology - Part 2: Terms relating to prostheses and prosthesis users
GB 14722 Modular hip, knee and thigh prostheses
GB 14723 General components for lower limb prostheses
GB/T 16432 Assistive products for rehabilitation - Classification and terminology
GB/T 35351 Additive manufacturing - Terminology
3 Terms and definitions
The terms and definitions defined in GB/T 14191.2, GB/T 16432 and GB/T 35351 as well as the following apply to this document.
3.1
data collection of lower limb stump
process of obtaining shape data of the lower limb stump using data collection tools
3.2
digital design of stump socket
process of designing a digital model of the stump socket through computer-aided design based on the collected data
3.3
additive manufacturing
process of manufacturing parts or physical objects by material accumulation based on three-dimensional model data
3.4
additive manufacturing of stump socket
process of conducting digital design of the stump socket based on lower limb stump data collection, and obtaining the stump socket using additive manufacturing technology with special additive manufacturing materials such as polymers and metals
3.5
lower limb prostheses assembled with additive manufactured stump socket
customized product delivered for use after assembling, aligning, etc., the additive manufactured stump socket with general components of lower limb prostheses and confirming the fit is qualified
3.6
surface model
mathematical or digital expression method that describes a physical object using a collection of planes and/or curved surfaces
4 Abbreviations
The following abbreviations apply to this document.
ABS: acrylonitrile-butadiene-styrene
AMF: additive manufacturing file format
CT: computed tomography
IGES: initial graphics exchange specification
MRI: magnetic resonance imaging
PA: polyamide
PETG: polyethylene terephthalate-1,4-cyclohexane dimethanol ester
PEEK: polyetheretherketone
PP: polypropylene
STL: standard triangulation language
TPU: thermoplastic urethane
5 Technical requirements
5.1 Requirements for lower limb stump data collection
5.1.1 Data collection methods
Data collection shall include but not be limited to one or more of the following methods:
a) Through 3D scanner;
b) Through CT or MRI tomography;
c) Through multi-angle photo synthesis;
d) Through fitting of discrete circumference measurements of the stump.
5.1.2 Data collection modes
Data collection shall include but not be limited to the following modes:
a) Collecting stump data: Using collection tools (including MRI) to collect data on the surface of the lower limb stump to directly obtain the digital model of the stump;
b) Collecting data of the plaster bandage negative mold: Using collection tools to collect data on the inner surface of the plaster bandage negative mold to indirectly obtain the digital model of the stump;
c) Collecting data of the plaster positive mold: Using collection tools to collect data on the surface of the plaster positive mold to indirectly obtain the digital model of the stump.
5.1.3 Process requirements for data collection
The following requirements shall be noted during the data collection process:
a) Digital collection equipment shall adopt a non-invasive acquisition method and shall not cause harm to the collector and the collected patient's human body;
b) Patient privacy shall be protected during the data collection process;
c) Appropriate positions and angles shall be selected for collection according to the patient's different conditions, the scanned part shall not be blocked, and the data collection shall be complete;
d) Collection markers shall be pasted on bony prominences and pressure-sensitive weight-bearing areas;
e) For patients with calf amputation, sagittal and frontal plane photos of the patient's seated stump and thigh area shall be taken; for patients with hip disarticulation amputation, thigh amputation, knee disarticulation amputation, and Syme amputation, sagittal and frontal plane photos of the lower body in the standing position shall be taken;
f) For complex stumps, videos may be taken;
g) According to the actual situation, the surface contour data of the stump may be collected repeatedly to analyze data differences.
