BS EN ISO 22523:2006

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
   4.1 Risk management
   4.2 Intended performance and technical documentation
   4.3 Clinical evaluation
   4.4 Strength and related conditions of use
5 Requirements for materials
   5.1 Flammability of materials and toxicity of combustion
       products
   5.2 Biocompatibility, contaminants and residues
       5.2.1 General
       5.2.2 Contaminants and residues
   5.3 Infection and microbiological contamination
   5.4 Resistance to corrosion and degradation
6 Noise and vibration
7 Electromagnetic compatibility (EMC)
8 Electrical safety
   8.1 Battery-powered prosthetic and orthotic devices
        8.1.1 Battery housings and connections
        8.1.2 Charge level indicators
   8.2 Circuit protection
   8.3 Electronic programmable systems
   8.4 Electrically heated blankets, pads and similar
        flexible heating appliances
   8.5 Prosthetic and orthotic devices with skin contact
        electrodes
   8.6 Prosthetic and orthotic devices with radio equipment
        8.6.1 General
        8.6.2 Frequency spectrum of radio equipment
        8.6.3 Operation of radio equipment by the user
9 Surface temperature
10 Sterility
11 Design requirements
   11.1 Safety of moving parts
   11.2 Safety of connections
12 Mechanical requirements
   12.1 Restrictions on use
   12.2 Forces in soft tissues of the human body
   12.3 Ergonomic principles
13 Information supplied by the manufacturer
   13.1 General
   13.2 Labelling
   13.3 Intended use
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 or moment required to operate the
                      control and actuating mechanisms on
                      prosthetic and orthotic devices
Annex E (informative) Reference to the essential principles
                      of safety and performance of medical
                      devices in accordance with ISO/TR 16142
Bibliography

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.

This International Standard specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO9999:

0603 - 0615 Orthoses

0618 - 0627 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 ISO9999 and it is not normally body worn.

NOTE1 It is intended to cover orthopaedic footwear (classification 0633) in the future.

NOTE2 The application of Quality Systems as described or referred to in ISO13485 and ISO13488 may be appropriate.