Overview
EN ISO 22523:2006 - External limb prostheses and external orthoses - specifies requirements and test methods for externally worn prosthetic and orthotic devices. Adopted by CEN from ISO 22523:2006, the standard applies to items classified in ISO 9999 as:
- 06 03 – 06 15 (Orthoses)
- 06 18 – 06 27 (Limb prostheses)
The standard addresses design and performance aspects including strength, materials, restrictions on use, risk management, and the information to be supplied for normal conditions of use. Note: special seating is excluded as it is not classified as an orthosis in ISO 9999.
Key Topics and Requirements
EN ISO 22523:2006 sets out technical requirements and test methods covering:
- Risk management and intended performance: documentation, clinical evaluation and conformity to intended use.
- Mechanical strength and durability: requirements for components and assemblies; guidance and test methods (see informative and normative annexes).
- Materials and safety: flammability, toxicity of combustion products, biocompatibility, contaminants, resistance to corrosion and degradation.
- Infection control and sterility: provisions where applicable.
- Noise, vibration and ergonomics: human factors, forces on soft tissues and restrictions on use.
- Electrical safety and EMC: battery-powered devices, circuit protection, electronic programmable systems, radio equipment and EMC considerations.
- Surface temperature and moving parts: safety limits and control of hazards from moving or heated elements.
- Information and labelling: manufacturer-supplied instructions, packaging, sterilization instructions and intended use statements.
- Normative and informative annexes: e.g., Annex A (upper-limb strength guidance), Annex B (normative mechanical test for knee joint assemblies), Annex C–E (flammability guidance, operating forces, and safety principles).
Practical Applications and Users
EN ISO 22523:2006 is used by:
- Manufacturers and product designers of prosthetic and orthotic components to design, test and document compliance.
- Test laboratories and quality engineers performing mechanical, electrical and material safety testing.
- Regulatory affairs and conformity assessors - the standard supports conformity with EU Directives (notably 93/42/EEC for medical devices and aspects of 99/5/EC for radio equipment) as referenced in Annex ZA.
- Clinicians, prosthetists and orthotists for understanding device limitations, safe use and labeling requirements.
- Procurement and healthcare organizations requiring standards-based specifications for assistive devices.
Related Standards
- ISO 9999 - Classification of products for persons with disability (used for scope classification).
- ISO/TR 16142 - Reference to essential principles of safety and performance (informative linkage in annexes).
- Relevant EU Directives: 93/42/EEC (medical devices) and 99/5/EC (radio equipment).
This standard is essential for ensuring the safety, performance and regulatory compliance of external limb prostheses and external orthoses.
