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
ANNEX ZA (informative) Clauses of this European Standard addressing
                       essential requirements or other provisions
                       of EU Directives
Bibliography