Overview

ISO 21065:2017 is an international standard providing a comprehensive vocabulary for the treatment and rehabilitation of persons with lower limb amputation. Developed by the International Organization for Standardization (ISO), this document standardizes terminology related to clinical phases and treatments, facilitating clear communication among healthcare professionals globally. By defining terms relevant to each stage of care, ISO 21065:2017 helps unify clinical practices and improves the consistency of medical records and rehabilitation outcomes.

This standard covers all essential phases-from pre-operative care to continuing care-and the treatments used during these phases, addressing common complications and their management. It targets healthcare providers specializing in prosthetics and orthotics, rehabilitation therapists, surgeons, and clinical teams involved in amputation care.

Key Topics

Phases of Care:
- Pre-operative care: Assessment, counseling, and preparation before surgery.
- Surgery: Anaesthesia, amputation procedure, infection and thromboembolism prevention.
- Immediate post-operative care: Recovery focus, pain management, stump care, psychological support.
- Early rehabilitation: Strengthening, stump conditioning, early walking aids training, prosthetic suitability assessment.
- Rehabilitation with or without prosthesis: Prosthetic fitting, gait training, activities of daily living (ADL) training, specialized rehabilitation.
- Continuing care: Ongoing medical care, prosthetic maintenance, social support, secondary complications prevention.
Treatments and Interventions:
- Medical, surgical, nursing, physical therapy, occupational therapy, and psychological support.
- Use of early walking aids, preparatory and definitive prostheses.
- Complication management such as infection control, pain relief (including phantom pain), revision surgeries, and rehabilitation therapies.
Complications Covered:
- Surgical site infections, excessive edema, wound dehiscence.
- Phantom pain, pressure ulcers, venous thrombosis, joint stiffness, depression.
- Neuromata, heterotopic ossification, adherent scar tissue, and stump-related issues.
Terminology Standardization:
- Uniform definitions for terms like stump (residuum), pre-operative care, early rehabilitation, temporary vs. definitive prostheses.
- Clarification of treatment modes and rehabilitation phases, enabling consistent documentation and communication.

Applications

ISO 21065:2017 is crucial for improving clinical practice and interdisciplinary coordination in prosthetics and orthotics by:

Enhancing Clinical Documentation:
- Using standardized vocabulary in patient records for accurate description of treatment stages and rehabilitation progress.
Facilitating Outcome Analysis:
- Allowing researchers and clinicians to compare treatment methods and rehabilitation outcomes internationally due to consistent terminology.
Supporting Treatment Planning:
- Assisting healthcare teams in designing phased treatment and rehabilitation programs tailored to individual patients.
Training and Education:
- Serving as a reference for training practitioners in prosthetics, orthotics, rehabilitation therapies, and amputation care.
Quality Assurance:
- Promoting standardized care, reducing ambiguity, and minimizing risks of miscommunication between multidisciplinary teams.

Related Standards

ISO 21065:2017 complements and relates to various other prosthetics and orthotics standards, such as:

ISO 8549 Series: Vocabulary for prosthetics and orthotics, providing general terminology and definitions.
ISO 22523: Requirements and test methods for prosthetic components.
ISO 16840: Body scanning and modeling for prosthetics fitting.
ISO 10993: Biological evaluation of medical devices, relevant for prosthetic materials.
ISO 13485: Quality management systems for medical devices, supporting manufacturing of prosthetics.

These related standards assist in ensuring safety, quality, and interoperability within the field of prosthetics and rehabilitation.

Keywords: ISO 21065, lower limb amputation, prosthetics terminology, orthotics, amputation rehabilitation, clinical phases, treatment vocabulary, prosthetic care, rehabilitation standard, medical terminology, healthcare documentation, prosthetic fitting, stump care, rehabilitation complications.

Overview

Key Topics

Phases of Care:
- Pre-operative care: Assessment, counseling, and preparation before surgery.
- Surgery: Anaesthesia, amputation procedure, infection and thromboembolism prevention.
- Immediate post-operative care: Recovery focus, pain management, stump care, psychological support.
- Early rehabilitation: Strengthening, stump conditioning, early walking aids training, prosthetic suitability assessment.
- Rehabilitation with or without prosthesis: Prosthetic fitting, gait training, activities of daily living (ADL) training, specialized rehabilitation.
- Continuing care: Ongoing medical care, prosthetic maintenance, social support, secondary complications prevention.
Treatments and Interventions:
- Medical, surgical, nursing, physical therapy, occupational therapy, and psychological support.
- Use of early walking aids, preparatory and definitive prostheses.
- Complication management such as infection control, pain relief (including phantom pain), revision surgeries, and rehabilitation therapies.
Complications Covered:
- Surgical site infections, excessive edema, wound dehiscence.
- Phantom pain, pressure ulcers, venous thrombosis, joint stiffness, depression.
- Neuromata, heterotopic ossification, adherent scar tissue, and stump-related issues.
Terminology Standardization:
- Uniform definitions for terms like stump (residuum), pre-operative care, early rehabilitation, temporary vs. definitive prostheses.
- Clarification of treatment modes and rehabilitation phases, enabling consistent documentation and communication.

Applications

ISO 21065:2017 is crucial for improving clinical practice and interdisciplinary coordination in prosthetics and orthotics by:

Enhancing Clinical Documentation:
- Using standardized vocabulary in patient records for accurate description of treatment stages and rehabilitation progress.
Facilitating Outcome Analysis:
- Allowing researchers and clinicians to compare treatment methods and rehabilitation outcomes internationally due to consistent terminology.
Supporting Treatment Planning:
- Assisting healthcare teams in designing phased treatment and rehabilitation programs tailored to individual patients.
Training and Education:
- Serving as a reference for training practitioners in prosthetics, orthotics, rehabilitation therapies, and amputation care.
Quality Assurance:
- Promoting standardized care, reducing ambiguity, and minimizing risks of miscommunication between multidisciplinary teams.

Related Standards

ISO 21065:2017 complements and relates to various other prosthetics and orthotics standards, such as:

ISO 8549 Series: Vocabulary for prosthetics and orthotics, providing general terminology and definitions.
ISO 22523: Requirements and test methods for prosthetic components.
ISO 16840: Body scanning and modeling for prosthetics fitting.
ISO 10993: Biological evaluation of medical devices, relevant for prosthetic materials.
ISO 13485: Quality management systems for medical devices, supporting manufacturing of prosthetics.

These related standards assist in ensuring safety, quality, and interoperability within the field of prosthetics and rehabilitation.

ISO 21065:2017 PDF

Technical details

Abstract

Overview

Key Topics

Applications

Related Standards

Related standards

Abstract

Overview

Key Topics

Applications

Related Standards

Related standards

Prosthetics and orthotics. Vocabulary - Terms relating to limb amputation

External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)

Wheelchair seating — Part 2: Determination of physical and mechanical characteristics of devices intended to…

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of…

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)