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