ISO 23158

ISO 23158:2021 is an international standard that specifies the requirements and testing methods for high-intensity therapeutic ultrasound (HITU) equipment used in medical treatments. This standard ensures that the devices meet safety, performance, and reliability parameters essential for patient care. With the increasing global focus on quality healthcare and medical device compliance, ISO 23158 certification plays a crucial role for manufacturers, importers, and healthcare institutions dealing with therapeutic ultrasound systems.

At Quality Asia Certification, we provide ISO 23158:2021 certification to companies manufacturing, distributing, or implementing high-intensity therapeutic ultrasound (HITU) equipment. Our certification process ensures your equipment complies with international safety norms and gains global market acceptance.

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What is ISO 23158?

ISO 23158:2021 is an international standard titled:

"Ultrasonics — High intensity therapeutic ultrasound (HITU) — Fields — Specification and methods of measurement in water."

It outlines the technical guidelines and validation procedures required to assess the acoustic fields produced by HITU devices. These devices are widely used for non-invasive medical procedures such as tumor ablation, drug delivery enhancement, and other therapeutic applications.

This standard:

  1. Defines methods to measure ultrasonic output in water.
  2. Ensures safety and consistency in therapy applications.
  3. Applies to medical manufacturers, regulatory bodies, and clinical users.


Why is ISO 23158 important?

ISO 23158:2021 certification is essential for manufacturers and stakeholders of HITU systems for several reasons:

  1. Global Recognition: Meet internationally accepted benchmarks and ease entry into regulated global markets.
  2. Patient Safety Assurance: Ensure that your ultrasound devices do not pose risks during therapeutic use.
  3. Compliance with MDR/FDA: Align with European MDR and US FDA quality expectations for medical equipment.
  4. Competitive Advantage: Build trust with buyers and distributors by showcasing compliance with this niche but critical standard.

In an industry where non-compliance can lead to recalls, legal issues, or patient harm, this certification offers a preventive, credible, and strategic advantage.

What are the benefits of ISO 23158?

  1. Standardized Testing Protocols: Offers uniform procedures to test and validate high-intensity therapeutic ultrasound equipment.
  2. Device Performance Verification: Ensures that HITU equipment delivers consistent therapeutic outcomes across clinical applications.
  3. Minimized Clinical Risk: Reduces the chances of equipment malfunction or inaccurate delivery of ultrasound energy.
  4. Supports R&D and Innovation: Establishes a strong foundation for the development of advanced therapeutic ultrasound technologies.

What kind of businesses can benefit from ISO 23158?

Implementing and getting certified for ISO 23158:2021 helps your business in multiple strategic and operational ways:

✅ Expand International Market Reach

ISO certification increases the credibility of your product across North America, Europe, and Asia-Pacific regions.

✅ Strengthen Regulatory Compliance

Comply with international regulations like MDR (EU), FDA (USA), and CDSCO (India) for medical devices.

✅ Enhance Product Reliability and Brand Trust

Certification assures stakeholders, hospitals, and clinicians of product quality and reliability.

✅ Facilitate Technical Dossiers and Audits

Aids in smoother audits and preparation of technical files for regulatory submission.

✅ Reduce Product Liability Risk

Demonstrating adherence to safety and performance standards lowers legal and operational risks.

✅ Enable Faster Product Launches

With certification, your product gets quicker approvals in regulated markets, speeding up time-to-market.

✅ Attract Strategic Partnerships

Certified products are often prioritized by procurement agencies, OEM clients, and government tenders.


Top Tips on making ISO 9001 effective for you.

#1

Top management commitment while practicing and accomplishing the standard is the key to success.

#2

Keeping staff informed about the ongoing practices, a well-communicated plan would increase the motivation and zeal of working in them.

#3

Making sure that the various departments of the organization work as a team for the benefit of the organization and customers as well.

#4

Review systems, policies, processes, and procedures for a smooth working of QMS.

#5

Speaking to customers & suppliers while getting feedback & working on improvements.

#6

Training staff carrying out the internal audits with the opportunity for improvement.

#7

Celebrate your achievement and use the QualityAsia Assurance Mark on your literature, promotional material, and website.

#8

Ensure continuous improvement by regularly reviewing and updating your quality management practices.

#9

Promote a culture of quality by encouraging innovation, accountability, and employee involvement at every level of the organization.

Why QualityAsia?

QualityAsia always vanguard in the auditing and governing of internationally acclaimed standards practices. At QualityAsia, we focus on driving the success of our clients through creating excellence with our trained professional auditors. The content of our service provision, comply with international certification rules defined by the accreditation bodies without burning a hole in your pocket. We will take you through the journey of audits with our best kept audit practices, viz.:

Initial Certification – Stage 1 (Preparatory Phase)
  • Thorough documented information review.
  • Exchange of information with staff through online or onsite presence.
  • Identification of key performances, processes & objectives as per the standard requisites.
  • Analysis of facilities, infrastructure, systems and processes in regard with the requested certification scope with a resource allocation review.

Initial Certification – Stage 2 (On-site Audit)
  • Measurement, reporting & reviewing the performances against key performances objectives.
  • Reviewing the suitability of the system meeting the legal, regulatory & contractual requirements.
  • Operational control of processes, internal audits & management reviews while understanding the responsibilities for the policies.
  • Conclusion based on prescriptive requirements, policy, performance objectives, staff skill, operations, procedures, internal audits, etc.


    Surveillance & Certification Renewal

    Drawing out the scrutiny on various aspects of the previously done audits on effectiveness while reviewing the various processes and control of the operations in the QMS and finally going for the recertification.

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