Certification Process Standards for Medical Equipment: Ensuring Safety, Performance, and Market Success
- Valentina Bosenko
- Feb 17
- 7 min read
Meeting the demands of today’s fast-evolving health care marketplace is more than just an issue of regulatory box-ticking—it’s a strategic imperative. Medical device manufacturers, suppliers, and health care providers face the challenge of delivering safe, reliable, and innovative equipment while continuously building public trust and market access. International standards for medical equipment certification have become vital milestones for achieving these goals. In this guide, we’ll review four key standards—covering contact lenses, medical X-ray diagnostic systems, radiotherapy treatment planning software, and sleep apnoea therapy equipment. By understanding and adopting these standards, businesses can boost productivity, enhance safety, and pave the way for secure, scalable operations.
Overview / Introduction
Health care is an industry where trust, safety, and consistent quality aren’t just virtues—they’re absolute necessities. The modern certification process for medical equipment isn’t simply about passing technical tests; it’s a rigorous journey to demonstrate the safety, performance, and reliability of products that millions of patients and professionals rely on every day.
With standards increasingly reflecting international consensus and technological progress, medical equipment manufacturers and providers are required to align with evolving expectations in shelf-life testing, radiation safety protocols, medical device software integrity, and home-care therapy device performance.
In this article, you will learn:
Why these standards matter in health care today
Key requirements of each covered standard
Implementation benefits and best practices
The clear pathway to robust, compliant, and competitive medical device operations
Detailed Standards Coverage
ISO 11987:2026 - Reliable Shelf-Life for Contact Lenses
Ophthalmic Optics — Contact Lenses — Determination of Shelf-Life
In the global vision care market, contact lens safety and efficacy depend greatly on the manufacturer’s ability to accurately determine and communicate product shelf-life. ISO 11987:2026 sets out the essential procedures for determining contact lens stability once sealed in their final packaging and held under controlled storage and distribution conditions.
What does this standard cover?
Scope: Defines test procedures (both real-time and accelerated studies) to ensure contact lenses remain stable, safe, and fully functional throughout storage and until use.
Key Requirements:
Risk assessment for material stability and packaging integrity
Testing under various environmental conditions (temperature, humidity)
Use of appropriate test media and industry-relevant measurement methods
Expression of results and full documentation in a comprehensive test report
Applicable To: Manufacturers, suppliers, and distributors of contact lenses worldwide, including regulatory authorities overseeing product approvals.
Practical Implications: Implementing ISO 11987:2026 allows companies to confidently establish realistic product expiry dates, minimize recalls, and ensure end users receive lenses at peak quality. By following these rigorous test protocols, businesses not only comply with market and regulatory demands but also prove their commitment to wearer safety.
Key highlights:
Detailed protocol for real-time and accelerated shelf-life testing
Focus on both lens material and packaging stability
Encourages robust risk management and traceable documentation
Access the full standard: View ISO 11987:2026 on iTeh Standards
SIST EN IEC 61267:2026 - Radiation Conditions for Medical Diagnostic X-ray Equipment
Medical Diagnostic X-ray Equipment - Radiation Conditions for Use in the Determination of Characteristics (IEC 61267:2025)
Safe, accurate, and reproducible diagnostic imaging depends on the ability to test and verify equipment under standardized radiation conditions. SIST EN IEC 61267:2026 provides globally accepted methods for generating, controlling, and verifying X-ray radiation conditions applicable in test laboratories and manufacturing plants.
What does this standard cover?
Scope: Establishes procedures for defining and reproducing X-ray radiation conditions required to determine the characteristics of medical diagnostic X-ray systems and components.
Key Requirements:
Definitions and verification of X-ray beam parameters (e.g., voltage, filtration, filtering materials)
Revised methods for radiation condition verification (new to the 2026 edition)
Tabulated signal-to-noise ratios and updates for mammography testing
Updated terminology and expanded coverage for multiple radiographic applications
Applicable To: Diagnostic X-ray machine manufacturers, quality assurance labs, regulatory bodies, radiological service equipment suppliers.
Practical Implications: Utilizing this standard ensures that diagnostic X-ray equipment consistently delivers reliable imaging quality while minimizing patient exposure. Adhering to SIST EN IEC 61267:2026 is critical to secure certification, streamline regulatory approvals, and meet industry safety benchmarks.
Key highlights:
Harmonized X-ray test conditions streamline certification and quality assurance
Supports consistent manufacturing and equipment comparison
Integrates standards for advanced applications like mammography
Access the full standard: View SIST EN IEC 61267:2026 on iTeh Standards
SIST EN IEC 62083:2026 - Safety of Radiotherapy Treatment Planning Software
Medical Device Software - Requirements for the Safety of Radiotherapy Treatment Planning Systems (IEC 62083:2025)
Radiotherapy depends on highly sophisticated software to plan and validate complex treatment regimens. SIST EN IEC 62083:2026 addresses both hardware and software elements, specifying key requirements to ensure robust, reliable, and secure operation of all radiotherapy treatment planning systems (TPS), including modern adaptive and cloud-based implementations.
What does this standard cover?
Scope: Sets out requirements for the design, manufacturing, installation, use, and maintenance of software used in radiotherapy TPS, regardless of whether it is stand-alone or integrated in broader systems.
Key Requirements:
Secure communication and data exchange between systems and devices
User qualifications and training, including clear instructions for use
Adaptive treatment planning and verification processes
Comprehensive documentation, configuration management, and audit trails for software changes
Rigorous testing during development and at the clinical site
Applicable To: Developers and manufacturers of radiotherapy TPS software, clinical IT managers, medical physicists, and regulators overseeing therapeutic medical device safety.
Practical Implications: Implementing this standard significantly reduces the risk of incorrect dosage, hardware/software integration faults, or unauthorized data manipulation. Compliance fosters greater confidence among clinicians and patients alike, and accelerates international market access for advanced therapeutic platforms.
Key highlights:
Adds requirements for adaptive radiotherapy methods
Highlights interfaces, user training, and comprehensive software management
Ensures quality, cyber-security, and operational reliability throughout the software life-cycle
Access the full standard: View SIST EN IEC 62083:2026 on iTeh Standards
SIST EN ISO 80601-2-70:2026 - Sleep Apnoea Breathing Therapy Equipment
Medical Electrical Equipment - Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnoea Breathing Therapy Equipment (ISO 80601-2-70:2025)
For millions living with obstructive sleep apnoea, reliable therapy devices are essential to restoring healthy sleep and preventing serious complications. SIST EN ISO 80601-2-70:2026 specifies the essential safety and performance requirements for breathing therapy equipment used both in hospitals and home-care environments.
What does this standard cover?
Scope: Outlines design, testing, and safety standards for sleep apnoea therapy equipment, focusing on CPAP (Continuous Positive Air Pressure) and bi-level positive airway pressure devices, as well as accessories that could impact safety and performance.
Key Requirements:
Basic safety features (protection from electrical, mechanical, and radiation hazards)
Essential performance under normal and single-fault conditions
Pressure accuracy, flowrate stability, and reliable alarm systems
Biocompatibility and hygiene (cleaning and disinfection protocols)
Clear marking, user documentation, and instructions for lay/home users
Applicable To: Manufacturers and importers of sleep apnoea therapy devices, hospitals, clinics, sleep centres, and home-care providers.
Practical Implications: Conformance with this standard gives users—both professionals and patients—confidence in device safety, while enabling manufacturers to access regulated markets globally. The standard is key for successful certification, minimizing risk of device failure, and maintaining a competitive edge in the home health care technology sector.
Key highlights:
Detailed criteria for both basic safety and essential performance
Covers home and professional use, including user training and documentation
Integrates requirements for both main equipment and critical accessories
Access the full standard: View SIST EN ISO 80601-2-70:2026 on iTeh Standards
Industry Impact & Compliance
Implementing international standards for medical equipment is no longer an optional extra but a prerequisite for successful business and public health assurance. Organizations that prioritize compliance with certification requirements built on these standards realize substantial advantages:
Business Benefits:
Market Access: Achieve and maintain market access in regulated territories worldwide, including the EU, US, and beyond.
Patient Safety: Demonstrate commitment to patient well-being, an essential driver for trust and brand reputation.
Productivity & Efficiency: Streamlined processes for shelf-life determination, equipment validation, and documentation save time and reduce costly rework.
Security: Advanced requirements help prevent unauthorized intervention, data leakage, and equipment misuse.
Risk Reduction: Reduced liability and insurance premiums by minimizing device failures or recalls.
Scaling: Standardized design, testing, and documentation make rapid product iteration and scaling easier as business grows.
Risks of Non-Compliance:
Withdrawal from key markets, product recalls, legal action, and loss of public trust
Increased vulnerability to security breaches and clinical errors
Disruption to innovation and R&D investments due to non-alignment with global best practices
Implementation Guidance
Adopting and implementing international medical equipment standards takes planning, teamwork, and a commitment to ongoing improvement. Here are effective strategies:
Gap Analysis:
Assess current products, processes, and documentation against the requirements of each applicable standard.
Stakeholder Training:
Train engineers, quality assurance teams, and regulatory officers on standard requirements and the rationale behind them.
Process Integration:
Incorporate standard-specific procedures in research, design, manufacturing, and post-market surveillance workflows.
Robust Documentation:
Keep thorough, auditable documentation for all tests, procedures, and risk assessments relevant to device certification.
Regular Audits & Updates:
Schedule internal and external audits; monitor and implement updates as standards evolve.
Engage with Certification Bodies:
Early engagement with notified bodies or regulatory authorities accelerates approval cycles and reduces compliance risks.
Leverage Expert Resources:
Consult standard-specific guidance documents, industry working groups, and online learning platforms for the latest interpretations and practical advice.
Best Practices:
Foster a company-wide culture of safety, quality, and regulatory awareness.
Prioritize digital tools for traceability, data management, and change control.
Involve end-users in feedback cycles to refine usability documentation and training materials.
Conclusion / Next Steps
Adherence to medical equipment standards is the cornerstone of a successful, responsible, and future-ready business strategy in health care. As technology and policy requirements rapidly evolve, staying compliant not only secures your organization against legal and operational risk, but actively enhances productivity, security, and scalability.
Key Takeaways:
Medical equipment certification standards provide a clear pathway to safety, quality, and market success.
Each standard—whether for contact lenses, diagnostic X-ray systems, radiotherapy software, or sleep apnoea devices—brings unique, practical benefits.
Implementation is a team effort: integrate standards-based thinking into design, manufacturing, support, and business strategy.
Your Next Steps:
Review which of these standards apply to your products or supply chain.
Access the full version of each standard to ensure you are working with up-to-date, authoritative requirements.
Position your organization at the forefront of health care innovation by building a strong, standards-based compliance framework.
Stay current, stay compliant, and lead the way in delivering safe, effective, and competitive medical equipment.
Comments