ISO 11334-1:2007 PDF

Assistive products for walking manipulated by one arm — Requirements and test methods — Part 1: Elbow crutches

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Title (English):

ISO 11334-1:2007

Assistive products for walking manipulated by one arm — Requirements and test methods — Part 1: Elbow crutches

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 17
Publication date:: January 17, 2007
Edition:: ISO IS 11334 edition 2 version 1
ICS:: 11.180.10

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Description (English):

ISO 11334-1:2007 specifies requirements and test methods for elbow crutches fully equipped with handgrip and tip. The methods specify testing of separation, static load capacity, fatigue and resistance to low temperature embrittlement. ISO 11334-1:2007 also gives the requirements relating to safety, ergonomics, performance, and information to be supplied by the manufacturer, including marking and labelling. The requirements and tests are based on every-day usage of elbow crutches when performing the through-swing gait, for a maximum user mass as specified by the manufacturer. ISO 11334-1:2007 is applicable to elbow crutches specified for a user mass of not less than 35 kg. Requirements and test methods for friction of rubber tips against the walking surface are dealt with separately.

Technical details

Technical committee: ISO/TC 173 - Assistive products
SKU: ISO 11334-1:2007

Abstract

Overview - ISO 11334-1:2007 (Elbow crutches)

ISO 11334-1:2007 specifies requirements and test methods for elbow crutches (assistive products for walking manipulated by one arm) fully equipped with handgrip and tip. The standard defines safety, ergonomics, performance and manufacturer information (marking and labelling) and establishes mechanical tests that reflect everyday use during the through-swing gait. It is applicable to elbow crutches intended for users of not less than 35 kg. Friction testing of rubber tips against walking surfaces is covered separately.

Key topics and technical requirements

Scope and definitions: terms such as cuff, handgrip, arm/leg section, tip, support and grip angles are defined to ensure consistent measurements.
Cuff requirements:
- Cuff internal depth must be > half the internal width.
- Front opening must be able to expand to 75 mm under a pulling force up to 120 N, with permanent deformation ≤ 5 mm.
Handgrip:
- May be adjustable but must remain secure after testing.
- Width requirement: 25–50 mm (except anatomical grips).
Leg section and tip:
- Tip must prevent penetration by the leg section and be replaceable and secure.
- Contact face diameter minimum: 35 mm.
Adjusting devices:
- Height adjustments must not loosen after mechanical tests and must be marked with maximum allowable elongation.
Materials:
- Structural components made from recycled plastics must have strength equivalent to virgin materials throughout the crutch life.
Mechanical durability and tests:
- Tests include separation, static loading, fatigue, and low-temperature falling.
- Typical test environment: 21°C ± 5°C.
- Test sequence: measurements → separation → static loading → fatigue → low temperature falling.

Practical applications - who uses ISO 11334-1:2007

Manufacturers and product designers of elbow crutches for design validation, conformity and product specification.
Testing laboratories and quality assurance teams to perform standardized mechanical, durability and safety tests.
Procurement and regulatory bodies for compliance verification and purchasing specifications in healthcare settings.
Clinicians and rehabilitation specialists who need assurance of ergonomics, safety and suitability for patient use.
Suppliers and retailers for accurate marking, labelling and documentation to meet regulatory expectations.

Related standards

ISO 9999 - Classification and terminology for assistive products.
EN 1041 - Information supplied by the manufacturer with medical devices.
ISO 11334 (other parts) - e.g., Part 4 for walking sticks with three or more legs.

Keywords: ISO 11334-1:2007, elbow crutches, assistive products, test methods, cuff, handgrip, static load, fatigue testing, low temperature embrittlement, safety, ergonomics, manufacturer information.

Related standards

Mentioned in the description and other ISO standards

Abstract

Overview - ISO 11334-1:2007 (Elbow crutches)

Key topics and technical requirements

Scope and definitions: terms such as cuff, handgrip, arm/leg section, tip, support and grip angles are defined to ensure consistent measurements.
Cuff requirements:
- Cuff internal depth must be > half the internal width.
- Front opening must be able to expand to 75 mm under a pulling force up to 120 N, with permanent deformation ≤ 5 mm.
Handgrip:
- May be adjustable but must remain secure after testing.
- Width requirement: 25–50 mm (except anatomical grips).
Leg section and tip:
- Tip must prevent penetration by the leg section and be replaceable and secure.
- Contact face diameter minimum: 35 mm.
Adjusting devices:
- Height adjustments must not loosen after mechanical tests and must be marked with maximum allowable elongation.
Materials:
- Structural components made from recycled plastics must have strength equivalent to virgin materials throughout the crutch life.
Mechanical durability and tests:
- Tests include separation, static loading, fatigue, and low-temperature falling.
- Typical test environment: 21°C ± 5°C.
- Test sequence: measurements → separation → static loading → fatigue → low temperature falling.

Practical applications - who uses ISO 11334-1:2007

Manufacturers and product designers of elbow crutches for design validation, conformity and product specification.
Testing laboratories and quality assurance teams to perform standardized mechanical, durability and safety tests.
Procurement and regulatory bodies for compliance verification and purchasing specifications in healthcare settings.
Clinicians and rehabilitation specialists who need assurance of ergonomics, safety and suitability for patient use.
Suppliers and retailers for accurate marking, labelling and documentation to meet regulatory expectations.

Related standards

ISO 9999 - Classification and terminology for assistive products.
EN 1041 - Information supplied by the manufacturer with medical devices.
ISO 11334 (other parts) - e.g., Part 4 for walking sticks with three or more legs.

ISO 11334-1:2007 PDF

Technical details

Abstract

Overview - ISO 11334-1:2007 (Elbow crutches)

Key topics and technical requirements

Practical applications - who uses ISO 11334-1:2007

Related standards

Related standards

Abstract

Overview - ISO 11334-1:2007 (Elbow crutches)

Key topics and technical requirements

Practical applications - who uses ISO 11334-1:2007

Related standards

Related standards

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