ISO 22523:2006
Current
Current
The latest, up-to-date edition.
External limb prostheses and external orthoses — Requirements and test methods
Available format(s)
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, French, Russian
Published date
14-09-2006
Important note : All end users must be registered with an Account prior to user licenses being assigned.
ISO 22523:2006 specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999:
- 06 03 - 06 15 Orthoses
- 06 18 - 06 27 Limb prostheses
It covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components.
This International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn.
| Committee |
ISO/TC 168
|
| DevelopmentNote |
Supersedes ISO/DIS 22523 (09/2006)
|
| DocumentType |
Standard
|
| Pages |
82
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| NF EN ISO 22523 : 2006 | Identical |
| GOST R ISO 22523 : 2007 | Identical |
| NBN EN ISO 22523 : 2006 | Identical |
| NEN EN ISO 22523 : 2006 | Identical |
| NS EN ISO 22523 : 1ED 2007 | Identical |
| I.S. EN ISO 22523:2006 | Identical |
| PN EN ISO 22523 : 2007 | Identical |
| SAC GB/T 30659 : 2014 | Identical |
| SN EN ISO 22523 : 2007 | Identical |
| UNI EN ISO 22523 : 2007 | Identical |
| SS-EN ISO 22523 : 2006 | Identical |
| UNE-EN ISO 22523:2007 | Identical |
| BS EN ISO 22523:2006 | Identical |
| EN ISO 22523:2006 | Identical |
| DIN EN ISO 22523:2007-04 | Identical |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| BS EN ISO 10328:2016 | Prosthetics. Structural testing of lower-limb prostheses. Requirements and test methods |
| I.S. EN ISO 22675:2016 | PROSTHETICS - TESTING OF ANKLE-FOOT DEVICES AND FOOT UNITS - REQUIREMENTS AND TEST METHODS (ISO 22675:2016) |
| VDI 5703:2015-09 | Systematical development for a model-based testing of medical devices |
| ISO/TS 16955:2016 | Prosthetics — Quantification of physical parameters of ankle foot devices and foot units |
| UNE-EN ISO 22675:2017 | Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016) |
| I.S. EN ISO 10328:2016 | PROSTHETICS - STRUCTURAL TESTING OF LOWER-LIMB PROSTHESES - REQUIREMENTS AND TEST METHODS (ISO 10328:2016) |
| PD IEC/TR 60601-4-1:2017 | Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy |
| BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| IEC TR 60601-4-1:2017 | Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy |
| ISO 10328:2016 | Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods |
| 13/30251846 DC : 0 | BS ISO 16955 - PROSTHETICS - QUANTIFICATION OF PHYSICAL PARAMETERS OF ANKLE FOOT DEVICES AND FOOT UNITS |
| ISO 22675:2016 | Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods |
| UNE-EN ISO 10328:2017 | Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016) |
| BS EN ISO 22675:2006 | Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods |
| EN ISO 22675:2016 | Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016) |
| EN ISO 10328:2016 | Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016) |
| PD ISO/TS 16955:2016 | Prosthetics. Quantification of physical parameters of ankle foot devices and foot units |
| ISO 8548-1:1989 | Prosthetics and orthotics — Limb deficiencies — Part 1: Method of describing limb deficiencies present at birth |
| EN 894-3:2000+A1:2008 | Safety of machinery - Ergonomics requirements for the design of displays and control actuators - Part 3: Control actuators |
| ISO 8548-3:1993 | Prosthetics and orthotics Limb deficiencies Part 3: Method of describing upper limb amputation stumps |
| ISO 8549-2:1989 | Prosthetics and orthotics Vocabulary Part 2: Terms relating to external limb prostheses and wearers of these prostheses |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| ISO 10328:2016 | Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods |
| ISO 13488:1996 | Quality systems — Medical devices — Particular requirements for the application of ISO 9002 |
| ISO 8191-2:1988 | Furniture — Assessment of ignitability of upholstered furniture — Part 2: Ignition source: match-flame equivalent |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 13405-2:2015 | Prosthetics and orthotics Classification and description of prosthetic components Part 2: Description of lower limb prosthetic components |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| EN 614-1:2006+A1:2009 | Safety of machinery - Ergonomic design principles - Part 1: Terminology and general principles |
| ISO 13405-1:2015 | Prosthetics and orthotics Classification and description of prosthetic components Part 1: Classification of prosthetic components |
| IEC 60335-2-17:2012+AMD1:2015 CSV | Household and similar electrical appliances - Safety - Part 2-17:Particular requirements for blankets, pads, clothing and similar flexible heating appliances |
| ISO 15032:2000 | Prostheses — Structural testing of hip units |
| ISO 8549-3:1989 | Prosthetics and orthotics Vocabulary Part 3: Terms relating to external orthoses |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ISO 8549-1:1989 | Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and external orthoses |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| BS 2574-3:1990 | Lower limb orthoses Method for the determination of mechanical properties of metal knee joint and side member assemblies |
| EN 12184:2014 | Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
| IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
| ISO 7176-21:2009 | Wheelchairs Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 16201:2006 | Technical aids for persons with disability — Environmental control systems for daily living |
| EN 50082-2 : 95 AC 95 | ELECTROMAGNETIC COMPATIBILITY - GENERIC IMMUNITY STANDARD - INDUSTRIAL ENVIRONMENT |
| ISO 554:1976 | Standard atmospheres for conditioning and/or testing — Specifications |
| ISO 9999:2016 | Assistive products for persons with disability Classification and terminology |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 13404:2007 | Prosthetics and orthotics — Categorization and description of external orthoses and orthotic components |
| ISO 13405-3:2015 | Prosthetics and orthotics Classification and description of prosthetic components Part 3: Description of upper limb prosthetic components |
| BS DD180(1989) : 1989 | GUIDE FOR THE ASSESSMENT OF TOXIC HAZARDS IN FIRE IN BUILDINGS AND TRANSPORT |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| ISO 22675:2016 | Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods |
| ISO 8548-2:1993 | Prosthetics and orthotics Limb deficiencies Part 2: Method of describing lower limb amputation stumps |
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