BS EN 12523:1999
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
External limb prostheses and external orthoses. Requirements and test methods
Hardcopy , PDF
10-26-2018
English
02-21-2003
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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Withdrawn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 |
| ISO 8548-2:1993 | Prosthetics and orthotics Limb deficiencies Part 2: Method of describing lower limb amputation stumps |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.