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IEC 60601 Electrical Safety Testing Service (Leakage/Ground) in Zambia
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IEC 60601 Electrical Safety Testing Service (Leakage/Ground) High-standard technical execution following OEM protocols and local regulatory frameworks.
Precision Leakage Current Analysis
We perform comprehensive leakage current testing according to IEC 60601 standards, ensuring your medical devices in Zambia meet stringent electrical safety requirements. Our advanced equipment precisely measures capacitive and resistive leakage currents under various fault conditions.
Robust Grounding Integrity Verification
Guaranteeing reliable protective earthing is paramount. Our service in Zambia meticulously verifies ground continuity for medical electrical equipment, adhering to IEC 60601-1 specifications to prevent shock hazards and ensure patient safety.
IEC 60601 Compliant Reporting
Receive detailed and compliant test reports for your medical devices' leakage and ground integrity, specifically tailored for regulatory submissions in Zambia. Our reports clearly document all test parameters, results, and adherence to IEC 60601-1 safety standards.
What Is Iec 60601 Electrical Safety Testing Service (Leakage/ground) In Zambia?
IEC 60601 electrical safety testing, specifically focusing on leakage current and protective earthing (ground) integrity, is a critical compliance requirement for medical electrical equipment. In Zambia, as globally, this service ensures that medical devices are designed and manufactured to minimize risks associated with electrical hazards, such as electric shock and fire, to both patients and healthcare professionals. Leakage current refers to the unintended flow of current through insulation to accessible parts of the equipment. Protective earthing (grounding) is a safety measure designed to provide a low-resistance path for fault currents to flow to the earth, preventing hazardous voltages from appearing on accessible conductive parts. This testing is performed by accredited laboratories or competent testing bodies adhering to the standards outlined in the IEC 60601 series of international standards, which are often adopted or referenced by national regulatory bodies.
| Who Needs IEC 60601 Leakage/Ground Testing? | Typical Use Cases | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Manufacturers of medical electrical equipment intending to sell or distribute within Zambia. | Infusion pumps | Ventilators | Diagnostic imaging equipment (X-ray, MRI, CT scanners) | Patient monitors | Surgical lights | Electrosurgical units | Defibrillators | Rehabilitation equipment | Laboratory diagnostic instruments used in healthcare settings | Any medical device incorporating electrical components that can come into contact with patients or operators. |
| Importers and distributors of medical electrical equipment in Zambia. | Healthcare facilities (hospitals, clinics, diagnostic centers) procuring new medical equipment. | Regulatory authorities in Zambia for market surveillance and approval processes. | Service and repair organizations during maintenance and recalibration activities. |
Key Aspects of IEC 60601 Leakage/Ground Testing Service in Zambia
- Purpose: To verify that medical electrical equipment meets stringent safety requirements regarding electrical insulation and grounding, thereby preventing patient and operator harm.
- Scope: Encompasses testing of various leakage current types (e.g., enclosure, patient, patient auxiliary) and the integrity of the protective earth connection.
- Methodology: Utilizes specialized test equipment simulating various fault conditions and human body impedance to measure current flow and earth resistance.
- Applicable Standards: Primarily IEC 60601-1 (General requirements for basic safety and essential performance) and its collateral standards.
- Certification/Verification: Successful completion of testing often leads to a test report and/or a certificate of compliance, which are essential for market access.
- Regulatory Context: While Zambia may have its own specific medical device regulations, adherence to IEC 60601 is a widely recognized international benchmark for safety.
Who Needs Iec 60601 Electrical Safety Testing Service (Leakage/ground) In Zambia?
IEC 60601 electrical safety testing, specifically focusing on leakage and ground (protective earthing) currents, is crucial for manufacturers and distributors of medical devices and equipment. In Zambia, this service is vital for ensuring the safety of patients and healthcare professionals from electrical hazards. This testing confirms that the device's insulation and earthing systems are functioning correctly to prevent dangerous current from flowing to the user or patient. Without this compliance, medical devices may pose significant risks and would likely not be approved for use in healthcare settings within Zambia.
| Customer Type | Primary Responsibility Regarding IEC 60601 Testing | Key Departments Involved in Zambia |
|---|---|---|
| Medical Device Manufacturers | Conducting and documenting IEC 60601 leakage and ground testing to meet regulatory requirements for market entry. | Quality Assurance, Research & Development, Compliance Departments. |
| Medical Equipment Importers/Distributors | Ensuring imported medical devices have undergone and passed IEC 60601 testing; potentially arranging for re-testing if local requirements differ or for older equipment. | Import/Export Compliance, Quality Control, Sales & Technical Support. |
| Healthcare Institutions | Specifying IEC 60601 compliance in procurement documents; verifying test reports for acquired equipment. | Biomedical Engineering, Procurement, Clinical Engineering. |
| Regulatory Bodies | Setting and enforcing medical device safety regulations; reviewing IEC 60601 test reports for market approval. | Ministry of Health, Zambia Bureau of Standards (ZABS) – if applicable to medical devices. |
Target Customers and Departments in Zambia Requiring IEC 60601 Electrical Safety Testing (Leakage/Ground)
- {"title":"Medical Device Manufacturers","description":"Companies that design, produce, and export medical devices and equipment intended for the Zambian market. They need to ensure their products meet international safety standards before distribution."}
- {"title":"Medical Equipment Importers and Distributors","description":"Businesses that import and distribute medical devices and equipment into Zambia. They are responsible for ensuring that the products they supply are safe and compliant with local regulations, which often align with international standards like IEC 60601."}
- {"title":"Healthcare Institutions (Hospitals, Clinics, Laboratories)","description":"While not directly performing the testing, these institutions are end-users and beneficiaries of compliant medical equipment. They rely on their procurement departments and Biomedical Engineering departments to ensure that all acquired equipment has undergone the necessary safety testing."}
- {"title":"Regulatory Bodies and Standards Organizations","description":"Government agencies and organizations responsible for regulating medical devices and ensuring public safety in Zambia. They may require evidence of IEC 60601 compliance for product registration and approval."}
- {"title":"Biomedical Engineering Departments","description":"Within healthcare institutions, these departments are responsible for the maintenance, repair, and safety of medical equipment. They often oversee procurement and require that new equipment meets established safety standards, including IEC 60601."}
- {"title":"Procurement Departments","description":"Responsible for acquiring medical devices and equipment for healthcare facilities. They need to ensure that all purchased items meet safety and regulatory requirements, including having passed IEC 60601 electrical safety testing."}
Iec 60601 Electrical Safety Testing Service (Leakage/ground) Process In Zambia
This document outlines the typical workflow for IEC 60601 electrical safety testing services, specifically focusing on leakage current and ground continuity (protective earthing) testing, within the Zambian regulatory and operational context. This process is crucial for medical device manufacturers and importers to ensure their products comply with international safety standards and are approved for use in Zambia.
| Stage | Description | Key Activities | Responsible Parties | Zambian Context/Considerations |
|---|---|---|---|---|
| The client (manufacturer/importer) contacts the testing laboratory to initiate the process. | Client provides details of the medical device (type, model, intended use). Laboratory provides information on IEC 60601 requirements, applicable standards, and testing scope. Discussion on timelines and initial cost estimation. | Client (Medical Device Manufacturer/Importer), Testing Laboratory | Understanding specific Zambian regulatory requirements or preference for certain standards. Zambia Bureau of Standards (ZABS) may be a point of reference for general safety regulations. |
| Based on the consultation, the laboratory provides a formal quotation for the testing services. | Laboratory submits a detailed quotation outlining scope of work, specific tests (leakage, ground continuity), estimated costs, turnaround time, and terms and conditions. Client reviews and accepts the quotation, leading to a formal service agreement. | Testing Laboratory, Client | Payment terms and invoicing procedures. Ensuring the quote aligns with budget and perceived value of compliance. |
| The client submits the required medical device samples to the testing laboratory. | Client prepares and ships the medical device(s) and any associated accessories or power cords. Proper packaging to prevent damage during transit. Lab receives and logs the samples, confirming receipt. | Client, Testing Laboratory | Logistics for shipping within Zambia or internationally. Customs clearance procedures may apply for imported devices if not already cleared. |
| The laboratory performs an initial review of the device and its documentation before commencing formal testing. | Visual inspection of the device for obvious defects. Review of user manuals, technical specifications, and any existing test reports. Identification of any potential hazards or aspects requiring specific attention during testing. | Testing Laboratory | Ensuring all necessary documentation is available and understandable. Local language considerations for manuals might be relevant in some cases, though English is standard in business. |
| The core testing phase where the device undergoes rigorous electrical safety evaluations. | Leakage Current Testing: Performed under various conditions (normal operation, single-fault conditions, different applied parts, AC/DC). Measurements are taken to ensure leakage current is within the limits specified by IEC 60601-1. Types of leakage current tested include earth leakage, enclosure leakage, and patient leakage (if applicable).<br>Ground Continuity (Protective Earthing) Testing: Verifies the integrity of the protective earth connection from accessible conductive parts to the mains earthing terminal. Low resistance measurements are taken to ensure effective earthing.<br>All tests are conducted using calibrated test equipment and documented meticulously. | Testing Laboratory | Adherence to IEC 60601-1 is paramount. The testing lab must be accredited or recognized to perform these tests. ZABS may have specific requirements for product registration that necessitate these reports. |
| Comprehensive documentation of all test procedures, results, and conclusions. | Laboratory generates a detailed test report including:<br>- Device identification (model, serial number).<br>- Standards tested against (e.g., IEC 60601-1:2005+A1:2012).<br>- Test setup and equipment used.<br>- Detailed results for each leakage current and ground continuity test.<br>- Pass/Fail status for each test.<br>- Any observed deviations or recommendations. | Testing Laboratory | The report must be clear and comprehensive to be accepted by regulatory bodies. ZABS often requires specific report formats or content. |
| The client reviews the test report to ensure accuracy and understanding. | Client reviews the report for completeness and accuracy. Any discrepancies or questions are addressed by the laboratory. Client formally approves the report. | Client, Testing Laboratory | Client's internal review process before proceeding with product registration or market entry. |
| Upon successful completion of testing and report approval, the laboratory issues a compliance certificate. | Testing laboratory issues a formal certificate of compliance, attesting that the device has met the specified IEC 60601 electrical safety requirements. This certificate is a key document for regulatory submissions. | Testing Laboratory | This certificate is often a prerequisite for ZABS product registration and market approval in Zambia. |
| Addressing any issues identified or changes made to the device. | If the device fails any tests, the client may need to make modifications and resubmit for re-testing. If the device design or components change significantly after initial testing, re-testing may be required to ensure continued compliance. | Client, Testing Laboratory | Cost implications of re-testing. Ensuring any modifications are properly documented and re-tested according to the standard. |
IEC 60601 Electrical Safety Testing Service (Leakage/Ground) Process in Zambia: Workflow from Inquiry to Execution
- 1. Initial Inquiry and Consultation:
- 2. Quotation and Agreement:
- 3. Sample Submission:
- 4. Pre-testing Assessment and Documentation Review:
- 5. Test Execution (Leakage Current & Ground Continuity):
- 6. Test Reporting:
- 7. Review and Approval:
- 8. Certificate Issuance:
- 9. Follow-up and Re-testing (if applicable):
Iec 60601 Electrical Safety Testing Service (Leakage/ground) Cost In Zambia
IEC 60601 electrical safety testing is a critical process for medical devices to ensure patient and operator safety by identifying potential hazards like leakage current and ensuring proper grounding. In Zambia, the cost of these services can vary significantly based on several factors. These factors influence the overall price, making it important for manufacturers and importers to get detailed quotes. Understanding these elements helps in budgeting and selecting the most suitable testing provider.
Key Pricing Factors for IEC 60601 Electrical Safety Testing (Leakage/Ground) in Zambia:
| Service Component | Estimated Cost Range (ZMW) | Notes |
|---|---|---|
| Basic Leakage Current Testing (per device, per configuration) | 1,500 - 4,000 | Covers essential leakage tests under normal and single-fault conditions. Range depends on device complexity. |
| Ground Continuity/Resistance Testing (per device) | 1,000 - 2,500 | Ensures effective grounding path. Simple to integrate with leakage testing. |
| Comprehensive IEC 60601-1 Testing (including leakage & ground) | 4,000 - 15,000+ | This is a broader package covering multiple safety aspects. The higher end is for complex, high-risk devices. May include multiple standards. |
| Re-testing / Troubleshooting | 500 - 2,000 (per hour/issue) | Charged for addressing non-compliance issues or re-testing after modifications. |
| Documentation and Report Generation | Included in test fees, but complex reports may add 500 - 2,000 | Standard reports are usually part of the service. Extra charges for highly customized or detailed reports. |
| Expedited Service Surcharge | 1,000 - 5,000+ | A percentage or flat fee applied for urgent testing. |
Factors Influencing IEC 60601 Electrical Safety Testing Costs in Zambia
- {"title":"Device Complexity and Type","description":"More complex medical devices with multiple power inputs, intricate circuitry, or a higher risk profile will generally require more extensive testing, leading to higher costs. The type of device (e.g., diagnostic, therapeutic, life-support) also plays a role in the perceived risk and thus the thoroughness of testing."}
- {"title":"Number of Test Points and Configurations","description":"Each individual test point and configuration on a device needs to be assessed. A device with numerous potential failure points or requiring testing under various operational modes will naturally incur higher testing fees."}
- {"title":"Testing Standards and Scope","description":"While IEC 60601 is the overarching standard, specific parts (e.g., IEC 60601-1 for general safety, IEC 60601-1-2 for electromagnetic compatibility) and sub-parts will dictate the exact tests performed. A broader scope of testing will increase the cost."}
- {"title":"Laboratory Accreditation and Reputation","description":"Well-established and accredited testing laboratories (e.g., those recognized by national metrology institutes or international bodies) often command higher prices due to their expertise, quality control, and the credibility they offer. Unaccredited or less established labs might offer lower prices but with potential risks."}
- {"title":"Volume of Testing","description":"Manufacturers or importers with a large volume of devices to test may be able to negotiate bulk discounts with testing service providers."}
- {"title":"Urgency of Testing","description":"Rush orders or expedited testing services typically come with a premium fee. Standard turnaround times are usually more cost-effective."}
- {"title":"Location and Overhead Costs","description":"The operating costs of the testing facility in Zambia, including rent, utilities, and skilled personnel, will be factored into the pricing. Labor costs for qualified technicians are a significant component."}
- {"title":"Reporting Requirements","description":"The detail and format of the test reports can vary. Comprehensive reports with detailed analysis and recommendations may incur additional charges compared to basic compliance reports."}
Affordable Iec 60601 Electrical Safety Testing Service (Leakage/ground) Options
Ensure your medical devices meet the stringent safety standards of IEC 60601 with our affordable electrical safety testing services. We specialize in leakage current and ground continuity testing, crucial parameters for device safety and patient well-being. Our cost-effective solutions are designed to help manufacturers, designers, and distributors achieve compliance without breaking the bank.
| Value Bundle Name | Included Services | Ideal For | Estimated Cost Savings (vs. individual testing) |
|---|---|---|---|
| Basic Compliance Bundle | Leakage Current Testing (Earth & Enclosure), Ground Continuity Testing | Startups, low-volume manufacturers, initial prototypes | 15-20% |
| Standard Compliance Bundle | Basic Bundle + Patient Leakage & Patient Auxiliary Leakage Testing | Most general medical devices, manufacturers needing comprehensive testing | 20-25% |
| Advanced Compliance Bundle | Standard Bundle + Application-Specific Leakage Scenarios (if applicable) | Devices with direct patient contact, complex designs, higher risk applications | 25-30% |
| Prototype & Pre-Compliance Bundle | Initial Leakage & Ground Testing, Identification of potential non-compliance issues | Early-stage product development, risk mitigation before formal testing | Cost varies greatly, but can save significant re-design costs (potentially 50%+) |
| Volume Discount Program | Applicable to any bundle for a high volume of devices or repeated testing needs | Manufacturers with ongoing production, multiple product lines | Tiered discounts starting at 10% for bulk orders |
Our IEC 60601 Electrical Safety Testing Services Include:
- Leakage Current Testing (Earth, Enclosure, Patient, Patient Auxiliary)
- Ground Continuity Testing (Protective Earth Resistance)
- Comprehensive Reporting and Documentation
- Pre-compliance Testing and Guidance
- Re-testing and Verification Services
Verified Providers In Zambia
Navigating the healthcare landscape in Zambia can be a challenge. Identifying truly verified providers who offer exceptional quality and reliable services is paramount for your well-being. Franance Health stands out as a beacon of trust, offering a curated network of healthcare professionals and facilities that have undergone rigorous vetting. Their commitment to patient-centric care, ethical practices, and adherence to international standards makes them the undisputed best choice for your healthcare needs in Zambia.
| Provider Type | Franance Health Verification | Key Benefits for Patients |
|---|---|---|
| Hospitals & Clinics | Accredited based on infrastructure, equipment, and staff qualifications. | Access to advanced medical technology and specialized departments. |
| Specialist Doctors | Verified medical licenses, board certifications, and peer reviews. | Expert diagnosis and treatment from leading medical professionals. |
| General Practitioners | Certified by relevant medical boards and screened for patient satisfaction. | Reliable primary care, preventive services, and health management. |
| Diagnostic Centers | Equipped with modern technology and staffed by experienced technicians. | Accurate and timely diagnostic results. |
Why Franance Health is the Best Choice:
- Rigorous Verification Process: Franance Health employs a multi-stage credentialing process, ensuring all listed providers meet stringent quality and ethical benchmarks.
- Patient-Centric Approach: They prioritize patient experience, focusing on accessibility, affordability, and personalized care.
- Access to Top Medical Talent: Franance Health connects you with highly qualified doctors, specialists, and state-of-the-art medical facilities across Zambia.
- Transparency and Trust: Their commitment to open communication and verifiable credentials builds unwavering trust.
- Comprehensive Healthcare Solutions: From routine check-ups to specialized treatments, Franance Health offers a holistic approach to your health.
Scope Of Work For Iec 60601 Electrical Safety Testing Service (Leakage/ground)
This Scope of Work (SOW) outlines the requirements for Electrical Safety Testing services specifically focusing on leakage current and ground continuity (also known as Protective Earthing/Bonding) for medical electrical equipment as per IEC 60601 series standards. The objective is to ensure the safety of patients, operators, and the environment from potential electrical hazards.
| Task | Description | Applicable Standards | Deliverables |
|---|---|---|---|
| Test Plan Development | Creation of a detailed test plan outlining the specific tests to be performed, test conditions, equipment settings, and pass/fail criteria based on the product's intended use and relevant IEC 60601 standards. | IEC 60601-1, applicable collateral standards, client-provided specifications. | Approved Test Plan. |
| Leakage Current Measurement | Measurement of touch current (operator/patient) and patient leakage current for both AC and DC components. This includes tests under normal conditions and single-fault conditions (e.g., open neutral, short circuit). | IEC 60601-1 (Clauses related to leakage current testing, e.g., 8.7, 19.4, 20.4), relevant collateral standards. | Measured leakage current values (mA), comparison to limits, indication of pass/fail for each test point. |
| Protective Earthing/Ground Continuity Testing | Measurement of the resistance of the protective earth/ground connection to ensure it is within the specified limits, typically <0.1 Ohm for Class I equipment. | IEC 60601-1 (Clause related to protective earthing, e.g., 8.6), relevant collateral standards. | Measured earth/ground resistance values (Ohm), comparison to limits, indication of pass/fail. |
| Earth/Ground Wire Strength Test | For certain equipment, verification of the mechanical integrity of the protective earth/ground conductor under strain. | IEC 60601-1 (Clause related to protective earthing, e.g., 8.6.3). | Indication of pass/fail for the strength test. |
| Test Report Generation | Comprehensive report detailing all performed tests, test conditions, equipment used, measured results, limits, and conclusions. The report will include photographic evidence where necessary. | IEC 60601-1, client-specific reporting requirements. | Detailed Electrical Safety Test Report, including test logs, raw data, and summary of findings. |
| Non-conformance Identification and Reporting | Identification and reporting of any test results that do not meet the specified limits or requirements. | IEC 60601-1, relevant collateral standards. | Clear documentation of any non-conformances, including specific test parameters and the nature of the failure. |
Key Standards and Test Categories
- IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
- IEC 60601-1-2: Electromagnetic compatibility (EMC) - Part 1-2: General requirements, tests and guidance for medical electrical equipment - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- IEC 60601-1-6: Usability - Part 1-6: General requirements, tests and guidance for medical electrical equipment - Collateral Standard: Usability.
- IEC 60601-1-8: Alarms - Part 1-8: General requirements, tests and guidance for medical electrical equipment - Collateral Standard: Alarm systems.
- IEC 60601-1-10: Physiological closed-loop controllers - Part 1-10: General requirements, tests and guidance for medical electrical equipment - Collateral Standard: Physiological closed-loop controllers.
- IEC 60601-1-11: Medical electrical equipment used in the home healthcare environment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Medical electrical equipment used in the home healthcare environment.
- IEC 60601-1-12: Medical electrical equipment used in emergency medical services environments - Part 1-12: General requirements for basic safety and essential performance - Collateral standard: Medical electrical equipment used in emergency medical services environments.
- IEC 60601-1-14: Medical electrical equipment - Part 1-14: General requirements for basic safety and essential performance - Collateral Standard: Medical electrical equipment employing anaesthetic and/or respiratory care functions.
- IEC 60601-2-xx (Specific Collateral Standards): Applicable for specialized medical equipment.
- Leakage Current Testing (Class I & Class II Equipment): Encompasses measurements of touch current and patient leakage current under normal and single-fault conditions.
- Protective Earthing/Ground Continuity Testing: Verification of the integrity and resistance of the protective earth/ground connection to prevent dangerous voltages from appearing on accessible conductive parts.
Service Level Agreement For Iec 60601 Electrical Safety Testing Service (Leakage/ground)
This Service Level Agreement (SLA) outlines the response times and uptime guarantees for the IEC 60601 Electrical Safety Testing Service, specifically focusing on Leakage/Ground current testing. This SLA applies to all services provided by [Your Company Name] (hereinafter referred to as "Provider") to [Client Company Name] (hereinafter referred to as "Client") for the aforementioned testing.
| Service Level Metric | Target | Measurement Period | Client Notification/Escalation |
|---|---|---|---|
| Uptime Guarantee (Leakage/Ground Testing Service) | 99.5% | Monthly | Downtime notifications will be sent via email within [Number] hours of detection. Client can escalate issues through [Escalation Contact/Method] if resolution is not met within target. |
| Response Time (Critical Issue - Service Unavailability) | < 1 hour | Per Incident | Immediate notification via [Method, e.g., phone, email]. Provider will acknowledge receipt and assign a technician within [Timeframe, e.g., 30 minutes]. |
| Response Time (High Priority Issue - Degraded Performance) | < 2 hours | Per Incident | Email notification. Provider will acknowledge receipt and begin investigation within [Timeframe, e.g., 1 hour]. |
| Response Time (Normal Priority Issue - Minor Fault/Inquiry) | < 4 business hours | Per Incident | Email notification. Provider will acknowledge receipt and begin investigation within [Timeframe, e.g., 2 business hours]. |
| Resolution Time (Critical Issue) | Within 4 hours (target) | Per Incident | Provider will provide status updates every [Frequency, e.g., 2 hours] until resolution or a new target is agreed upon. |
| Resolution Time (High Priority Issue) | Within 8 business hours (target) | Per Incident | Provider will provide status updates every [Frequency, e.g., 4 business hours] until resolution or a new target is agreed upon. |
| Resolution Time (Normal Priority Issue) | Within 2 business days (target) | Per Incident | Provider will provide status updates as needed. |
Key Definitions
- Scheduled Maintenance: Planned downtime for system updates, upgrades, or preventive maintenance, communicated to the Client at least [Number] days in advance.
- Unscheduled Downtime: Any period when the testing service is unavailable to the Client due to unforeseen issues, excluding scheduled maintenance, force majeure events, or Client-induced issues.
- Response Time: The maximum time allowed for the Provider to acknowledge and begin working on a reported issue.
- Resolution Time: The maximum time allowed for the Provider to resolve a reported issue and restore the service to normal operation. This is contingent on the complexity of the issue.
- Service Hours: The period during which the testing service is available and monitored by the Provider. Typically, this will be [Specify your standard service hours, e.g., 24/7, business hours (9 AM - 5 PM)] excluding weekends and public holidays unless otherwise specified.
- Availability: The percentage of time the testing service is operational and accessible to the Client during Service Hours.
In-Depth Guidance
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