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BS EN 12523:1999

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

External limb prostheses and external orthoses. Requirements and test methods
Available format(s)

Hardcopy , PDF

Withdrawn date

26-10-2018

Language(s)

English

Published date

21-02-2003

Foreword
1 Scope
2 Normative references
3 Definitions
4 General requirements
5 Requirements for materials
6 Noise and vibration
7 Electromagnetic compatibility (EMC)
8 Electrical safety
9 Surface temperature
10 Sterility
11 Design requirements
12 Mechanical requirements
13 Information supplied by the manufacturer
14 Packaging
Annex A (informative) Guidance on methods of determining
the strength of upper limb prosthetic devices
Annex B (normative) Method of determining the mechanical
properties of knee joint assemblies for lower limb orthotic
devices
Annex C (informative) Guidance on methods of determining
the flammability and toxicity of combustion products of
lower limb prosthetic devices
Annex D (informative) Guidance on methods of establishing
the force required to operate the controls on prosthetic and
orthotic devices
Annex E (informative) Bibliography
Annex Z (informative) Clauses of this European Standard
addressing essential requirements or other provisions of EU
Directives

Covers test methods and requirements for external limb prostheses and external orthoses, including the following classifications from EN ISO 9999: 06 03 - 06 15 Orthoses, 06 18 - 06 27 Limb prostheses. Covers materials, strength, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components. Does not cover special seating as it is not classified as an orthosis in EN ISO 9999 and it is not normally body-worn.

Committee
CH/168
DevelopmentNote
Supersedes BS 2574-3(1990) and 96/563185 DC (03/2003)
DocumentType
Standard
Pages
60
PublisherName
British Standards Institution
Status
Withdrawn
SupersededBy
Supersedes

Standards Relationship
NS EN 12523 : 1ED 1999 Identical
NBN EN 12523 : 1999 Identical
NF EN 12523 : 1999 Identical
DIN EN 12523:1999-05 Identical
NEN EN 12523 : 1999 Identical
UNI EN 12523 : 2001 Identical
UNE-EN 12523:1999 Identical
I.S. EN 12523:1999 Identical
SN EN 12523 : 1999 Identical
EN 12523 : 1999 Identical

ISO 8548-1:1989 Prosthetics and orthotics — Limb deficiencies — Part 1: Method of describing limb deficiencies present at birth
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
EN ISO 9999:2016 Assistive products for persons with disability - Classification and terminology (ISO 9999:2016)
ISO 10328-1:1996 Prosthetics Structural testing of lower-limb prostheses Part 1: Test configurations
ISO 10328-4:1996 Prosthetics Structural testing of lower-limb prostheses Part 4: Loading parameters of principal structural tests
ISO 10328-3:1996 Prosthetics Structural testing of lower-limb prostheses Part 3: Principal structural tests
ISO 8191-2:1988 Furniture — Assessment of ignitability of upholstered furniture — Part 2: Ignition source: match-flame equivalent
EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
ISO 10328-8:1996 Prosthetics Structural testing of lower-limb prostheses Part 8: Test report
ISO 10328-5:1996 Prosthetics — Structural testing of lower-limb prostheses — Part 5: Supplementary structural tests
ISO 13405-2:2015 Prosthetics and orthotics Classification and description of prosthetic components Part 2: Description of lower limb prosthetic components
EN 540 : 1993 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
ISO 13405-1:2015 Prosthetics and orthotics Classification and description of prosthetic components Part 1: Classification of prosthetic components
ISO 8549-3:1989 Prosthetics and orthotics Vocabulary Part 3: Terms relating to external orthoses
ISO 8549-1:1989 Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and external orthoses
ISO 10328-2:1996 Prosthetics Structural testing of lower-limb prostheses Part 2: Test samples
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
EN 60967:1992/A51:1994 SAFETY OF ELECTRICALLY HEATED BLANKETS, PADS AND SIMILAR FLEXIBLE HEATING APPLIANCES FOR HOUSEHOLD USE
ISO 10328-7:1996 Prosthetics Structural testing of lower-limb prostheses Part 7: Test submission document
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
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
EN 60601-1-4:1996/A1:1999 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
ISO 10328-6:1996 Prosthetics Structural testing of lower-limb prostheses Part 6: Loading parameters of supplementary structural tests
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
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
ISO 8548-2:1993 Prosthetics and orthotics Limb deficiencies Part 2: Method of describing lower limb amputation stumps

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