IEC 62353 Recurrent Test Service (In-Service Testing) in Nigeria
Engineering Excellence & Technical Support
IEC 62353 Recurrent Test Service (In-Service Testing) High-standard technical execution following OEM protocols and local regulatory frameworks.
Ensuring Patient Safety through IEC 62353 Compliance
Our recurrent testing service for medical electrical equipment in Nigeria strictly adheres to IEC 62353 standards. We meticulously verify electrical safety parameters like protective earthing, enclosure leakage current, and touch current, minimizing risks of electric shock to patients and operators. This proactive approach safeguards critical healthcare operations.
Performance Verification for Optimal Medical Device Functionality
Beyond basic safety, our IEC 62353 recurrent testing in Nigeria includes functional and performance verifications. We assess key parameters and device outputs against manufacturers' specifications, ensuring accurate diagnoses and effective treatments. This commitment to performance optimizes medical device reliability and patient care outcomes.
Comprehensive Documentation & Traceability for Regulatory Adherence
We provide detailed, tamper-proof documentation for all IEC 62353 recurrent tests conducted on medical equipment across Nigeria. This includes test results, calibration records, and device history, facilitating seamless regulatory compliance and providing a robust audit trail. Ensure your facility meets national and international standards with our transparent reporting.
What Is Iec 62353 Recurrent Test Service (In-service Testing) In Nigeria?
IEC 62353, titled "Medical electrical equipment – Routine kiểm tra and grounds for recurrent kiểm tra" (in-service testing), establishes standardized procedures for the recurrent electrical safety testing of medical devices after initial installation and during their operational lifespan. This standard is crucial for ensuring the continued safety and performance of medical equipment within healthcare facilities, mitigating risks associated with device malfunction or degradation that could lead to patient or operator harm. In Nigeria, the implementation and adherence to IEC 62353 principles for recurrent testing are paramount for regulatory compliance, patient safety assurance, and maintaining the integrity of healthcare delivery.
The service involves a systematic series of electrical safety tests performed at regular intervals. These tests are designed to verify that the medical device continues to meet the safety requirements it was designed and certified to, particularly concerning protection against electric shock. Key aspects of the testing include:
- Protective Earth Resistance (Earthing) Test: Measures the continuity and integrity of the protective earth connection to ensure fault currents are safely dissipated.
- Enclosure Leakage Current Test: Assesses the current that could flow through the external conductive parts of the device to earth under normal and single-fault conditions.
- Patient Leakage Current Test: Evaluates the current that could flow from applied parts (patient connections) to earth under normal and single-fault conditions, categorized by Type B, BF, and CF applied parts.
- Patient Auxiliary Current Test: For devices with powered applied parts, this test measures currents that could flow through the patient from applied parts to other conductive parts of the device.
- Insulation Resistance Test: Verifies the integrity of the insulation between conductive parts and the chassis.
- Functional Tests: While primarily focused on electrical safety, IEC 62353 may also include basic functional checks to ensure the device is operating as intended, as a compromised function can sometimes lead to safety hazards.
The specific test parameters and acceptable limits are defined within IEC 62353, often referencing requirements from IEC 60601 series standards. The frequency of recurrent testing is typically determined by the manufacturer's recommendations, regulatory requirements, the type of device, its usage intensity, and the prevailing environmental conditions.
| Typical Use Case | Description | Relevance to IEC 62353 Recurrent Testing |
|---|---|---|
| Routine Maintenance Schedule | Hospitals typically have scheduled maintenance for all medical equipment. IEC 62353 testing is integrated into these schedules. | Ensures that all tested equipment consistently meets electrical safety benchmarks as part of a proactive maintenance strategy. |
| Post-Repair Verification | After a medical device has undergone repairs or servicing, electrical safety tests are mandatory to confirm that the repairs did not introduce any new safety hazards. | Confirms that the device remains electrically safe after intervention, aligning with the 'grounds for recurrent testing' aspect of the standard. |
| Pre-Purchase Assessment of Used Equipment | When acquiring second-hand medical equipment, performing an IEC 62353 test provides assurance of its current safety status. | Validates the safety of equipment that may have undergone significant operational use and potential undocumented maintenance. |
| Compliance Audits | Healthcare facilities may undergo audits by internal or external bodies to verify adherence to safety regulations and standards. | Provides documented evidence that the facility is meeting its obligations for ensuring the electrical safety of its medical equipment. |
| Risk Management Programs | Incorporating IEC 62353 testing into a facility's broader risk management framework helps to systematically identify and mitigate potential electrical hazards. | Contributes to a comprehensive patient safety strategy by addressing a specific category of medical device-related risks. |
| Equipment Retirement Decisions | While not the primary purpose, recurring test results can inform decisions about when a device may no longer be safe or cost-effective to maintain. | Provides objective data that can support the justification for replacing older, potentially less safe equipment. |
Who Needs IEC 62353 Recurrent Test Service in Nigeria?
- Hospitals and Clinics: All healthcare facilities, regardless of size or specialization, that utilize medical electrical equipment require this service to ensure the safety of their patients and staff.
- Diagnostic Centers: Facilities offering imaging, laboratory, and other diagnostic services rely heavily on a wide array of medical devices that must be regularly tested.
- Government and Private Healthcare Providers: Both public and private healthcare institutions are mandated or strongly advised to comply with these safety standards.
- Medical Device Manufacturers and Distributors (for after-sales support): While they certify devices initially, they may offer or recommend recurrent testing services as part of their comprehensive support packages.
- Third-Party Biomedical Engineering Service Providers: These organizations specialize in providing maintenance, repair, and testing services for medical equipment, including IEC 62353 compliant testing.
- Regulatory Bodies (as a compliance measure): Although not directly requiring the service, regulatory bodies responsible for healthcare facility oversight and medical device safety often mandate evidence of such testing.
- Users of High-Risk Medical Equipment: Devices classified as high-risk or those with direct patient contact are prime candidates for rigorous and frequent recurrent testing.
Who Needs Iec 62353 Recurrent Test Service (In-service Testing) In Nigeria?
IEC 62353, also known as "Medical electrical equipment – Part 2: Particular requirements for the basic safety and essential performance of medical equipment in service," is a critical international standard for ensuring the safety and performance of medical devices once they are in use. In Nigeria, the recurrent testing (in-service testing) mandated by this standard is crucial for a wide range of healthcare facilities and organizations. These tests are designed to identify potential hazards that may arise during the normal operation of medical equipment due to wear and tear, environmental factors, or other operational issues. By adhering to IEC 62353, healthcare providers can significantly reduce the risk of equipment failure, patient harm, and staff injury. The implementation of these regular checks is vital for maintaining the integrity and reliability of the medical technology that underpins patient care.
| Target Customer | Relevant Departments / Personnel |
|---|---|
| Hospitals (Public and Private) | Biomedical Engineering Department, Clinical Engineering Department, Quality Assurance Department, Ward Managers, Department Heads (e.g., Radiology, Cardiology, ICU), Maintenance Teams |
| Clinics and Medical Centers | Chief Medical Officer, Clinic Administrators, Lead Nurses, Technicians responsible for equipment |
| Diagnostic Laboratories | Laboratory Managers, Quality Control Managers, Biomedical Technicians, Lab Technologists |
| Specialized Healthcare Facilities | Facility Directors, Department Supervisors, Biomedical Staff, Technical Operators |
| Ambulatory Surgical Centers | Surgical Department Heads, Nursing Supervisors, Biomedical Technicians, Facility Administrators |
| Dental Clinics with advanced equipment | Lead Dentist, Clinic Manager, Dental Assistants responsible for equipment maintenance |
| Research Institutions | Principal Investigators, Research Facility Managers, Technical Support Staff, Lab Managers |
| Medical Equipment Manufacturers and Distributors | After-Sales Service Department, Technical Support Teams, Field Service Engineers |
| Third-Party Biomedical Engineering Service Providers | Service Managers, Biomedical Engineers, Field Service Technicians, Sales and Business Development Teams |
| Government Health Agencies and Regulators | Regulatory Compliance Officers, Health Facility Inspectors, Quality Management Units |
| Non-Governmental Organizations (NGOs) | Program Managers, Operations Managers, Healthcare Facility Coordinators, Biomedical Technicians (if employed) |
Who Needs IEC 62353 Recurrent Test Service (In-Service Testing) in Nigeria?
- Hospitals (Public and Private)
- Clinics and Medical Centers
- Diagnostic Laboratories
- Specialized Healthcare Facilities (e.g., Dialysis Centers, Physiotherapy Clinics)
- Ambulatory Surgical Centers
- Dental Clinics with advanced equipment
- Research Institutions with medical devices
- Medical Equipment Manufacturers and Distributors (for their service departments)
- Third-Party Biomedical Engineering Service Providers
- Government Health Agencies and Regulators
- Non-Governmental Organizations (NGOs) involved in healthcare delivery
Iec 62353 Recurrent Test Service (In-service Testing) Process In Nigeria
IEC 62353, also known as "Medical electrical equipment - Routine checks and test after repair of medical electrical equipment," is a crucial international standard for ensuring the safety and proper functioning of medical devices while they are in service. In Nigeria, the implementation of this standard for recurrent testing (in-service testing) involves a structured process that ensures compliance and patient safety. This workflow outlines the typical journey of a medical facility or organization seeking IEC 62353 recurrent test services.
| Stage | Description | Key Activities | Responsible Parties | Typical Timeline |
|---|---|---|---|---|
| The medical facility or organization identifies the need for IEC 62353 recurrent testing and initiates contact with a qualified service provider. | Contacting service providers, discussing testing requirements, understanding the scope of services, inquiring about qualifications and accreditations. | Medical Facility/Organization (Client), Service Provider (Vendor) | 1-3 business days |
| Based on the inquiry, the service provider prepares a detailed proposal and quotation for the testing services. A formal agreement is established. | Receiving and reviewing quotation, negotiating terms and pricing, signing a service agreement or contract, defining payment terms. | Service Provider (Vendor), Medical Facility/Organization (Client) | 2-5 business days |
| The testing schedule is agreed upon, and the medical facility prepares the equipment and environment for testing. | Coordinating testing dates and times with the facility, identifying specific equipment for testing, ensuring equipment is accessible and in a safe operational state, designating a point of contact at the facility. | Medical Facility/Organization (Client), Service Provider (Vendor) | 1-2 weeks (depending on availability and scale) |
| Trained technicians from the service provider visit the facility and conduct the IEC 62353 recurrent tests according to the standard's requirements. | Performing visual inspections, electrical safety tests (e.g., protective earth continuity, enclosure leakage current, patient leakage current), functional tests, documentation of test results using calibrated equipment, adhering to safety protocols. | Service Provider (Vendor) - Certified Technicians | Varies significantly based on the number and type of devices (can range from hours to days) |
| The collected test data is analyzed by the service provider to determine compliance with IEC 62353 requirements. | Reviewing raw test data, comparing results against standard limits, identifying any deviations or failures, compiling a comprehensive test report. | Service Provider (Vendor) - Technical Staff | 2-7 business days after testing completion |
| The generated test report is submitted to the medical facility, often accompanied by recommendations for any necessary corrective actions. | Submitting the test report to the client, explaining the findings, providing clear recommendations for repair or maintenance if equipment fails, advising on next steps for non-compliant devices. | Service Provider (Vendor), Medical Facility/Organization (Client) | 1-2 business days |
| Upon satisfactory completion of testing and any necessary remediation, a formal test certificate is issued, confirming compliance. | Issuing a formal IEC 62353 recurrent test certificate, providing documentation for regulatory or internal audit purposes, indicating that the equipment has passed the in-service tests. | Service Provider (Vendor) | Concurrent with or immediately after report approval |
| The service provider maintains records of the testing, and the medical facility integrates these into their asset management and safety compliance systems. | Archiving test reports and certificates, advising on re-testing intervals, providing ongoing support or consultation if needed, ensuring the facility maintains its own records for regulatory compliance. | Service Provider (Vendor), Medical Facility/Organization (Client) | Ongoing |
IEC 62353 Recurrent Test Service (In-Service Testing) Process in Nigeria: Workflow
- 1. Inquiry and Initial Consultation:
- 2. Quotation and Service Agreement:
- 3. Scheduling and Pre-Test Preparations:
- 4. On-Site Testing Execution:
- 5. Data Analysis and Report Generation:
- 6. Report Review and Remediation Recommendations:
- 7. Issuance of Test Certificate and Compliance Documentation:
- 8. Post-Test Follow-up and Record Keeping:
Iec 62353 Recurrent Test Service (In-service Testing) Cost In Nigeria
IEC 62353, also known as "Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of medical electrical equipment in service," mandates recurrent testing for medical devices to ensure their safety and performance. This in-service testing is crucial for patient safety and regulatory compliance. In Nigeria, the cost of IEC 62353 recurrent test services can vary significantly based on several factors. These services are typically provided by specialized biomedical engineering firms, calibration laboratories, or accredited third-party testing bodies. The pricing is usually determined on a per-device basis, but larger contracts or bulk testing can often secure better rates.
| Device Category (Example) | Estimated Cost Range (NGN) | Notes |
|---|---|---|
| Basic Diagnostic Devices (e.g., BP Monitors, Thermometers) | ₦15,000 - ₦40,000 per device | Relatively simple electrical systems, quick testing time. |
| Patient Monitoring Systems (e.g., ECG Monitors, Pulse Oximeters) | ₦30,000 - ₦75,000 per device | Involve multiple parameters and slightly more complex circuitry. |
| Therapeutic Devices (e.g., Infusion Pumps, Syringe Pumps) | ₦40,000 - ₦100,000 per device | Critical for patient care, requiring precise performance and electrical safety checks. |
| Imaging Equipment (e.g., X-ray Machines, Ultrasound Machines - specific modules) | ₦75,000 - ₦250,000+ per module/unit | Complex, high-voltage equipment. Costs are highly variable depending on the specific unit and its components. Full system testing can be significantly higher. |
| Anesthesia Machines & Ventilators | ₦70,000 - ₦200,000 per device | Life-support equipment with stringent safety and performance requirements. |
| Large, Complex Medical Systems (e.g., MRI, CT Scanners) | ₦200,000 - ₦1,000,000+ per system | Extremely complex and expensive to test. Pricing is often on a project basis and requires specialized expertise and equipment. This range is a rough estimate and can vary dramatically. |
Key Pricing Factors for IEC 62353 Recurrent Test Services in Nigeria:
- Type of Medical Device: The complexity and classification of the medical device are primary drivers of cost. A simple blood pressure monitor will cost less to test than a sophisticated MRI machine or an anesthesia delivery system. Devices with multiple safety features or intricate electrical pathways require more time and expertise.
- Number of Devices: As mentioned, the quantity of devices requiring testing significantly influences the overall cost. Hospitals or clinics with a large inventory of medical equipment can negotiate volume discounts.
- Location of Testing: Whether the testing is conducted on-site at the healthcare facility or at the service provider's laboratory can impact the price. On-site testing usually incurs additional charges for travel, logistics, and technician time.
- Frequency of Testing: While IEC 62353 specifies recurrent testing intervals, the specific manufacturer's recommendations or the healthcare facility's risk management policies might dictate more frequent testing, potentially leading to higher cumulative costs over time.
- Urgency of Service: Expedited testing services, where immediate turnaround is required, will generally command a premium price.
- Service Provider's Expertise and Accreditation: Reputable service providers with certified technicians, advanced testing equipment, and relevant accreditations (e.g., ISO 17025 for calibration laboratories) may charge higher fees due to their proven competence and quality assurance.
- Scope of Testing: The extent of the IEC 62353 testing can vary. Some providers might offer basic safety checks, while others provide comprehensive performance validation and electrical safety assessments. A more in-depth assessment will naturally cost more.
- Reporting and Documentation: The level of detail and format of the test reports can also influence pricing. Comprehensive reports with detailed findings, calibration certificates, and recommendations are more valuable and may be priced accordingly.
- Calibration of Test Equipment: The service provider's own test equipment must be regularly calibrated and certified to traceable standards. This ongoing cost is factored into their service pricing.
Affordable Iec 62353 Recurrent Test Service (In-service Testing) Options
Ensuring medical device safety through IEC 62353 recurrent testing (in-service testing) is crucial for patient well-being and regulatory compliance. We offer affordable and comprehensive service options designed to meet your budget without compromising on quality. Our value bundles and cost-saving strategies are tailored to provide maximum benefit and minimize your operational expenses.
| Value Bundle | Description | Key Cost-Saving Benefit |
|---|---|---|
| Basic Compliance Bundle | Includes essential IEC 62353 testing for a defined number of devices with standard reporting. | Economical entry point for essential safety compliance. |
| Standard Efficiency Bundle | Combines IEC 62353 testing with basic preventative maintenance for increased device reliability. | Reduces risk of breakdowns and costly emergency repairs. |
| Comprehensive Care Bundle | Includes full IEC 62353 testing, advanced preventative maintenance, and priority scheduling. | Maximizes uptime, ensures compliance, and offers peace of mind at a competitive price. |
| Network-Wide Solution | Customized testing and maintenance plans for entire healthcare networks with centralized reporting and dedicated account management. | Achieves significant economies of scale and streamlined management. |
Affordable IEC 62353 Recurrent Test Service Options
- Tiered Service Packages: We provide flexible packages based on the volume of devices, testing frequency, and required reporting detail. This allows you to choose the level of service that best suits your needs.
- Multi-Device Discounts: Significant discounts are applied when you bundle multiple devices for testing, making it more cost-effective to manage your entire medical equipment inventory.
- Annual Service Agreements: Lock in preferential pricing and predictable budgeting with our annual service agreements, which often include priority scheduling and dedicated support.
- Remote Support & Consultation: For certain aspects of compliance and preparation, we offer remote support and consultation services to reduce on-site visit costs.
- Bundled Preventative Maintenance: Combine your IEC 62353 testing with our preventative maintenance services for a holistic approach to device upkeep, leading to greater efficiency and reduced future repair costs.
- Proactive Scheduling: Our team works with you to proactively schedule tests, avoiding costly emergency call-outs and ensuring compliance well in advance of deadlines.
- Consolidated Reporting: Receive consolidated, easy-to-understand reports for all your tested devices, simplifying your record-keeping and audit preparation.
- Training & Best Practice Guidance: We offer guidance and training on best practices for in-service testing and device management, empowering your internal teams and potentially reducing the need for external services in the long run.
- Partnership Programs: For larger healthcare facilities or networks, we offer partnership programs with exclusive pricing and customized service level agreements.
- Flexible Payment Options: Discuss our flexible payment plans to find an option that aligns with your financial cycle.
Verified Providers In Nigeria
In Nigeria's evolving healthcare landscape, identifying and choosing truly Verified Providers is paramount for individuals and families seeking reliable medical services. This is where Franance Health distinguishes itself. Franance Health is not just another healthcare directory; it is a rigorous vetting platform dedicated to ensuring that every provider listed has met stringent credentialing standards. This meticulous process guarantees that you are accessing healthcare professionals and facilities that are not only licensed but also adhere to best practices and ethical guidelines. Understanding Franance Health's credentialing process reveals why they represent the best choice for finding verified healthcare in Nigeria. Their commitment to transparency and quality assurance directly translates to peace of mind for patients, reducing the risk of encountering unqualified or substandard care. By prioritizing these verified providers, you are investing in your health with confidence.
| Benefit for Patients | Franance Health's Role | Why it's the Best Choice |
|---|---|---|
| Access to Qualified Professionals: Ensures you see doctors, nurses, and specialists who are legitimately trained and licensed. | Franance Health meticulously verifies each practitioner's license and academic credentials. | Reduces the risk of encountering quacks or unqualified individuals, prioritizing your safety and well-being. |
| Reliable and Ethical Care: Promotes confidence in the ethical conduct and professional standards of healthcare providers. | Their vetting process includes checks for disciplinary records and adherence to professional conduct. | Ensures you receive respectful, professional, and morally sound medical treatment. |
| Improved Patient Outcomes: Connects you with providers who have proven experience and are committed to quality. | Validation of experience and ongoing quality checks by Franance Health. | Increases the likelihood of accurate diagnoses, effective treatments, and positive health results. |
| Peace of Mind and Reduced Stress: Alleviates the anxiety of searching for healthcare in an unregulated environment. | Franance Health provides a trusted, curated list of verified providers. | Allows you to focus on your health needs without the added burden of uncertainty and extensive personal verification. |
| Transparency and Trust: Builds a foundation of trust between patients and healthcare providers. | Franance Health's transparent credentialing methodology is openly communicated. | Empowers patients with clear information, fostering a trusting relationship with their chosen healthcare providers. |
Franance Health Credentialing Process - What it Means for You
- Licensing Verification: Ensuring all listed practitioners hold valid and current licenses issued by the relevant Nigerian medical regulatory bodies (e.g., Medical and Dental Council of Nigeria, Nursing and Midwifery Council of Nigeria).
- Educational Background Check: Validating academic qualifications and professional training from recognized institutions.
- Experience Validation: Confirming the professional experience claimed by healthcare providers through reference checks and verifiable employment history.
- Reputation and Disciplinary Record Review: Conducting due diligence to identify any adverse actions, sanctions, or disciplinary proceedings against providers.
- Facility Standards Assessment (where applicable): For clinics and hospitals, assessing compliance with health and safety regulations, equipment availability, and operational protocols.
- Continuous Monitoring: Implementing mechanisms for ongoing review and updates of provider credentials to ensure continued compliance.
- Patient Feedback Integration: Incorporating verified patient feedback as part of a comprehensive quality assessment.
Scope Of Work For Iec 62353 Recurrent Test Service (In-service Testing)
This Scope of Work (SOW) outlines the requirements for providing IEC 62353 recurrent testing services for medical electrical equipment (MEE) currently in service within your facility. The objective is to ensure continued safety and compliance of MEE through periodic in-service testing.
| Category | Description | Standard/Specification | Deliverable |
|---|---|---|---|
| Test Scope Definition | Identification and confirmation of all MEE requiring recurrent testing, including model numbers, serial numbers, and locations. | IEC 62353:2014 (Medical electrical equipment - Procedures for the basic safety and essential performance testing after repair and”! before use) | Comprehensive list of MEE to be tested. |
| Test Execution | Performance of all required safety tests as per IEC 62353, including but not limited to: Protective Earthing/Bonding Resistance, Enclosure Leakage Current, Patient Leakage Current (Type B, BF, CF), Applied Parts Leakage Current, Insulation Resistance, Functional Tests (as applicable). | IEC 62353:2014 (Section 5 & 6) | On-site testing of individual MEE units. |
| Test Equipment | Utilization of calibrated and validated test equipment suitable for IEC 62353 testing. | Manufacturer's specifications for test equipment, relevant calibration certificates. | Test equipment logs and calibration records. |
| Documentation and Reporting | Detailed recording of all test results for each MEE, including measured values, pass/fail status, and any observed anomalies. | IEC 62353:2014 (Section 7) | Individual test reports for each MEE, summarized test report, and recommendations for corrective actions. |
| Non-Conformance Reporting | Prompt reporting of any MEE failing to meet the safety requirements of IEC 62353, including detailed descriptions of the failures and recommendations for repair or decommissioning. | IEC 62353:2014 (Section 7.3) | Non-conformance reports (NCRs) for failed equipment. |
| Calibration Status | Verification and documentation of the calibration status of tested MEE where applicable. | Manufacturer's recommendations for calibration intervals. | Record of MEE calibration status. |
| Training (Optional) | Provision of basic training to in-house biomedical engineering staff on IEC 62353 requirements and basic safety testing procedures. | IEC 62353:2014 | Training materials and attendance records. |
Objectives of IEC 62353 Recurrent Test Service
- Verify the safety of in-service medical electrical equipment (MEE) according to IEC 62353.
- Identify and document any potential safety hazards or deviations from acceptable limits.
- Provide recommendations for remediation of identified issues.
- Ensure compliance with relevant regulatory requirements and hospital policies.
- Minimize the risk of electrical shock or other electrical hazards to patients and operators.
Service Level Agreement For Iec 62353 Recurrent Test Service (In-service Testing)
This Service Level Agreement (SLA) outlines the response times and uptime guarantees for the IEC 62353 Recurrent Test Service (In-Service Testing). This service ensures medical devices are tested according to the IEC 62353 standard, confirming their safety for continued in-service use. The objective is to minimize disruption to clinical operations while maintaining the highest safety standards.
| Service Component/Incident Type | Response Time Guarantee | Resolution Time Target (for Critical Incidents) | Uptime Guarantee (Monthly) |
|---|---|---|---|
| Scheduled Testing Request (Non-Urgent) | Acknowledge within 8 business hours. Schedule within 5 business days. | N/A | N/A |
| Unscheduled/Ad-Hoc Testing Request (Non-Urgent) | Acknowledge within 4 business hours. Schedule within 7 business days. | N/A | N/A |
| Reporting of Service Disruption (Critical Incident) | Acknowledge within 1 hour (24/7) | Within 8 business hours | 99.5% |
| Reporting of Service Disruption (Standard Incident) | Acknowledge within 4 business hours | Within 24 business hours | 99.5% |
| Routine Service/Preventative Maintenance | As per agreed schedule. | N/A | N/A |
Key Definitions
- Service Provider: The entity offering the IEC 62353 Recurrent Test Service.
- Customer: The healthcare organization or entity procuring the IEC 62353 Recurrent Test Service.
- In-Service Testing: The testing of medical devices while they are in active clinical use, following the IEC 62353 standard.
- Scheduled Maintenance: Pre-planned maintenance activities performed by the Service Provider to ensure optimal performance of testing equipment and systems. Customers will be notified at least 48 hours in advance of scheduled maintenance windows, which will be performed during off-peak hours whenever possible.
- Downtime: A period where the IEC 62353 Recurrent Test Service is unavailable to the Customer, rendering it impossible to conduct scheduled or unscheduled testing. Scheduled maintenance is excluded from Downtime calculations.
- Response Time: The maximum time elapsed between the Customer reporting an issue or requesting a service and the Service Provider acknowledging and initiating a response (e.g., assigning a technician, beginning remote diagnostics).
- Resolution Time: The maximum time elapsed between the Service Provider initiating a response and the issue being resolved, allowing the service to be fully functional.
- Uptime Guarantee: The percentage of time the IEC 62353 Recurrent Test Service is available and operational to the Customer over a given period.
- Critical Incident: A service outage that significantly impacts the ability to conduct essential IEC 62353 recurrent testing for a substantial portion of the Customer's medical device inventory.
- Standard Incident: A service disruption that causes a minor inconvenience but does not critically impact the overall testing schedule or safety of a large number of devices.
Frequently Asked Questions
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