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What is ISO 21856:2022?

ISO 21856:2022 specifies general requirements and associated test methods for assistive products not covered by other specific ISO standards. It applies to a wide range of non-invasive assistive technologies used at home, in institutions, or public environments.

Key elements covered include:

  1. Structural safety and stability
  2. Risk mitigation for users
  3. Environmental durability
  4. Labelling and documentation requirements
  5. Testing procedures to verify performance

This standard plays a critical role in enhancing accessibility, user safety, and global market acceptance.

Why is ISO 21856:2022 important?

As the demand for accessible and inclusive technologies increases worldwide, ISO 21856:2022 has become a cornerstone for manufacturers aiming to ensure their products are safe, compliant, and fit for diverse user needs.

Whether you're targeting healthcare, elder care, rehabilitation, or public infrastructure sectors, compliance with ISO 21856:

  1. Builds trust with customers and caregivers
  2. Ensures your assistive product stands up to international scrutiny
  3. Helps avoid costly recalls or regulatory issues
  4. Supports entry into global markets with harmonized standards


What are the benefits of ISO 21856:2022?

  1. Enhanced product safety – Minimize the risk of injury or malfunction in high-dependency devices.
  2. Validated product quality – Ensure consistency across design, materials, and usability.
  3. Global market acceptance – Meet international buyer expectations and regulatory requirements.
  4. Faster approvals in regulated sectors – Ease compliance with local and national authorities.
  5. Reduced liability risks – Show documented commitment to quality and safety.

What kind of businesses can benefit from ISO 21856:2022?

Implementing ISO 21856:2022 can bring powerful advantages to your organization:

  1. Win International Contracts: Demonstrate global compliance to buyers and regulatory bodies.
  2. Increase Customer Confidence: Boost user and caregiver trust with certified safety and durability.
  3. Support R&D with Standards-Driven Innovation: Guide product development with robust, testable criteria.
  4. Improve Market Positioning: Stand out in tenders and B2B procurement through verified quality.
  5. Reduce Operational Risks: Avoid product failures, legal disputes, and reputational damage.
  6. Streamline Quality Management: Integrate ISO 21856 with your existing QMS (like ISO 9001) for better process control.
  7. Faster Time to Market: Pre-certify product elements to speed up regulatory approvals.


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