DIN EN ISO 22523:2007-04
External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006); English version of DIN EN ISO 22523:2007-04

Standard No.

DIN EN ISO 22523:2007-04

Release Date

2007

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 22523:2022-05

Latest

DIN EN ISO 22523:2022-05

Replace

DIN EN ISO 22523:2004 DIN EN 22523:2004 DIN EN 12523:1999

Scope

This International Standard specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999: 0603-06 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. NOTE 1 It is intended to cover orthopaedic footwear (classification 06 33) in the future. NOTE 2 The application of Quality Systems as described or referred to in ISO 13485 and ISO 13488 may be appropriate.

DIN EN ISO 22523:2007-04 Referenced Document

• EN 1041 Information supplied by the manufacturer of medical devices*， 2013-09-01 Update
• EN 50082-2 Electromagnetic Compatibility Generic Immunity Standard Part 2: Industrial Environment
• IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests*， 2024-04-18 Update
• IEC 60601-1:1988 Medical electrical equipment; part 1: general requirements for safety
• IEC 61000-4-3 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test*， 2020-09-08 Update
• ISO 10328 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods*， 2016-06-01 Update
• ISO 13405-1 Prosthetics and orthotics - Classification and description of prosthetic components - Part 1: Classification of prosthetic components*， 2015-01-01 Update
• ISO 13405-2 Prosthetics and orthotics - Classification and description of prosthetic components - Part 2: Description of lower limb prosthetic components*， 2015-01-01 Update
• ISO 13405-3 Prosthetics and orthotics - Classification and description of prosthetic components - Part 3: Description of upper limb prosthetic components*， 2015-01-01 Update
• ISO 15032 Prostheses - Structural testing of hip units
• ISO 22675 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods*， 2016-06-01 Update
• ISO 8548-1 Prosthetics and orthotics; limb deficiencies; part 1: method of describing limb deficiencies present at birth
• ISO 8548-2 Prosthetics and orthotics — Limb deficiencies — Part 2: Method of describing lower limb amputation stumps*， 2020-04-01 Update
• ISO 8548-3 Prosthetics and orthotics; limb deficiencies; part 3: method of describing upper limb amputation stumps
• ISO 8549-1 Prosthetics and orthotics — Vocabulary — Part 1: General terms for external limb prostheses and external orthoses*， 2020-09-15 Update
• ISO 8549-2 Prosthetics and orthotics — Vocabulary — Part 2: Terms relating to external limb prostheses*， 2023-10-01 Update
• ISO 8549-3 Prosthetics and orthotics — Vocabulary — Part 3: Terms relating to orthoses*， 2020-09-15 Update

DIN EN ISO 22523:2007-04 history

• 2022 DIN EN ISO 22523:2022-05 External limb prostheses and external orthoses - Requirements and test methods (ISO/DIS 22523:2022); German and English version prEN ISO 22523:2022 / Note: Date of issue 2022-04-15*Intended as replacement for DIN EN ISO 22523 (2007-04).
• 2007 DIN EN ISO 22523:2007-04 External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006); English version of DIN EN ISO 22523:2007-04
• 2007 DIN EN ISO 22523:2007 External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
• 0000 DIN EN 22523:2004
• 1970 DIN EN 12523:1999

DIN EN ISO 22523:2007-04 External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006); English version of DIN EN ISO 22523:2007-04 has been changed from DIN EN 12523:1999 .