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IEC 62353 Recurrent Test Service (In-Service Testing) in Niger Engineering Excellence & Technical Support

IEC 62353 Recurrent Test Service (In-Service Testing) High-standard technical execution following OEM protocols and local regulatory frameworks.

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Enhanced Patient Safety through Grounding Continuity Assurance

Our IEC 62353 recurrent tests in Niger meticulously verify grounding continuity for all connected medical devices. This critical step ensures that leakage currents are safely channeled away from patients, significantly reducing the risk of electrical shock and upholding the highest standards of patient safety during medical procedures.

Mitigation of Electrical Hazards via Insulation Resistance Verification

We perform rigorous insulation resistance testing as per IEC 62353, validating the integrity of electrical insulation within medical equipment. This proactive measure in Niger's healthcare facilities prevents unintended electrical pathways and safeguards both patients and healthcare professionals from potential electrical hazards.

Early Detection of Equipment Faults to Prevent Malfunctions

Our in-service testing service employs comprehensive diagnostic checks to identify subtle insulation degradation and potential fault conditions before they escalate. This early detection capability in Niger ensures medical equipment operates reliably, minimizing the likelihood of critical malfunctions during patient care and maintaining uninterrupted service delivery.

What Is Iec 62353 Recurrent Test Service (In-service Testing) In Niger?

IEC 62353 is an international standard that specifies the requirements for the recurrent (in-service) testing of medical electrical equipment. In Niger, this standard provides a framework for ensuring the continued safety and performance of medical devices after they have been placed into service and are in regular use. The core objective is to identify and mitigate potential hazards that may arise from the aging, wear and tear, or damage of equipment, or from improper maintenance or modification. This testing is a crucial component of a comprehensive medical equipment management program, aiming to protect patients, operators, and the public from electrical, mechanical, and other hazards.

AspectDescriptionSignificance in Niger
Service DefinitionIEC 62353 recurrent testing involves periodic, systematic testing of medical electrical equipment while it is in operational use. This is distinct from initial type testing (performed by manufacturers) or routine preventative maintenance (which may involve cleaning, calibration, and minor adjustments). Recurrent testing specifically focuses on verifying the continued compliance of the equipment with applicable safety standards, particularly regarding electrical safety (e.g., protective earthing, insulation, leakage currents) and performance characteristics essential for safe operation. The testing procedures are generally based on the original design and manufacturing specifications, as well as any relevant updates or modifications.Ensures ongoing patient safety and the reliability of diagnostic and therapeutic procedures in healthcare facilities across Niger. Supports regulatory compliance and risk management for healthcare providers.
Testing PerformedThe service involves a structured set of tests, typically including:
  • Visual inspection for physical damage or deterioration.
  • Electrical safety tests (e.g., protective earth resistance, insulation resistance, touch current, patient leakage current, applied part leakage current).
  • Functional checks to verify critical operational parameters and safety mechanisms.
  • Mechanical safety checks (where applicable).
  • Documentation review, including service manuals and previous test records.
Provides objective data on the safety status of medical devices, enabling informed decisions regarding maintenance, repair, or decommissioning.
Who Needs It?Healthcare facilities in Niger, including:
  • Public and private hospitals.
  • Clinics and health centers.
  • Diagnostic imaging centers.
  • Dental practices.
  • Veterinary clinics (for equipment used in a medical context).
  • Medical device manufacturers and their authorized service representatives (for equipment under warranty or service contracts).
  • Regulatory bodies overseeing healthcare infrastructure.
Mandatory for most healthcare institutions to ensure a safe and effective healthcare environment. Essential for demonstrating due diligence in patient care and risk mitigation.
Typical Use Cases
  1. Routine Safety Assurance: After a defined period (e.g., annually), all critical medical electrical equipment undergoes testing to confirm its continued safety.
  2. Post-Repair Verification: Following any repair or significant maintenance, recurrent testing is performed to ensure the repair has not compromised the equipment's safety or performance.
  3. Pre-Acquisition Assessment: Before purchasing used medical equipment, recurrent testing can be conducted to assess its safety and operational status.
  4. Compliance Audits: For internal or external audits, demonstrating compliance with IEC 62353 through recurrent testing records is crucial.
  5. Risk Management: Identifying potential hazards early through regular testing helps prevent adverse events and associated liabilities.
Reduces the incidence of medical device-related accidents and injuries. Optimizes the lifespan and operational efficiency of medical equipment. Contributes to a culture of safety within healthcare institutions.
Service ProvidersTypically provided by specialized third-party biomedical engineering service companies, in-house biomedical engineering departments within larger healthcare institutions, or accredited testing laboratories. Service providers must possess qualified personnel, calibrated test equipment traceable to national or international standards, and a comprehensive understanding of IEC 62353 requirements.Availability of skilled technicians and accredited service providers is key to widespread implementation. Government and professional bodies may play a role in accrediting service providers.

IEC 62353 Recurrent Test Service (In-Service Testing) in Niger

  • Definition and Scope
  • Who Needs IEC 62353 Testing?
  • Typical Use Cases
  • Key Testing Categories

Who Needs Iec 62353 Recurrent Test Service (In-service Testing) In Niger?

IEC 62353 recurrent test service, also known as in-service testing, is crucial for ensuring the ongoing safety and reliability of medical electrical equipment after it has been put into use. In Niger, like any other country, the need for such services extends across various healthcare facilities and government entities responsible for public health and safety. These tests are vital to prevent equipment failures that could lead to patient harm, misdiagnosis, or operational disruptions within healthcare settings. The service is not just a regulatory compliance measure but a proactive approach to patient care and operational efficiency.

Target Customer/DepartmentWhy They Need IEC 62353 Recurrent TestingKey Benefits
Public Hospitals and ClinicsTo ensure patient safety, comply with national health regulations, and maintain the operational integrity of life-saving medical devices.Reduced risk of equipment-related patient harm, extended equipment lifespan, improved diagnostic accuracy, avoidance of costly emergency repairs.
Private Hospitals and ClinicsTo uphold a high standard of patient care, maintain reputation, mitigate liability risks, and ensure optimal functionality of diagnostic and therapeutic equipment.Enhanced patient trust, competitive advantage through reliable services, reduced insurance premiums, efficient use of capital investments.
Specialized Medical Centers (e.g., diagnostic labs, imaging centers)To guarantee the accuracy and reliability of diagnostic tests and imaging procedures, which are directly dependent on calibrated and safe equipment.Accurate and timely diagnoses, prevention of repeat tests due to equipment malfunction, consistent service quality.
Non-Governmental Organization (NGO) Healthcare ProvidersTo maximize the impact of limited resources by ensuring the longevity and safety of donated or procured medical equipment, particularly in remote areas.Sustainable healthcare delivery, efficient use of donor funds, improved health outcomes in underserved populations.
Government Ministries (Ministry of Health, Ministry of Public Safety)To set and enforce safety standards for medical equipment across the nation, protect public health, and ensure effective healthcare system functioning.Regulatory compliance, standardization of healthcare quality, public trust in the healthcare system, informed policy-making.
Medical Equipment Distributors and Service ProvidersTo offer comprehensive maintenance and support services to their clients, fulfill contractual obligations, and maintain their professional accreditation and reputation.Customer satisfaction, recurring revenue streams, avoidance of warranty claims, market differentiation, professional credibility.

Who Needs IEC 62353 Recurrent Test Service (In-Service Testing) in Niger?

  • Public Hospitals and Clinics
  • Private Hospitals and Clinics
  • Specialized Medical Centers (e.g., diagnostic labs, imaging centers)
  • Non-Governmental Organization (NGO) Healthcare Providers
  • Government Ministries responsible for Health and Public Safety
  • Medical Equipment Distributors and Service Providers

Iec 62353 Recurrent Test Service (In-service Testing) Process In Niger

The IEC 62353 recurrent test service, also known as in-service testing, is a critical process for ensuring the safety and reliability of medical electrical equipment in Niger. This process involves a series of steps designed to verify that equipment continues to meet safety standards after it has been put into use. The workflow typically begins with an inquiry from a healthcare facility and culminates in the successful completion and documentation of the tests.

StageDescriptionKey ActivitiesResponsible PartiesTypical Timeline
Inquiry and Initial ContactThe healthcare facility recognizes the need for recurrent testing and initiates contact with a qualified service provider in Niger.Contacting service providers, expressing need for IEC 62353 testing, initial discussion of equipment inventory.Healthcare Facility, Potential Service Provider1-3 business days
Quotation and Service AgreementThe service provider assesses the scope of work and provides a detailed quotation. Upon agreement, a service contract is established.Reviewing equipment list, assessing complexity, preparing quotation, negotiating terms, signing service agreement.Potential Service Provider, Healthcare Facility3-7 business days
Scheduling and LogisticsDates and times for the on-site testing are agreed upon, and necessary logistical arrangements are made.Confirming availability of equipment and testing personnel, arranging access to facilities, planning travel and accommodation (if required).Service Provider, Healthcare Facility1-2 weeks
Pre-Test PreparationThe service provider prepares the necessary testing equipment, documentation, and ensures their personnel are briefed on the specific equipment to be tested.Calibrating testing equipment, reviewing equipment manuals and previous test reports, assigning qualified technicians.Service ProviderOngoing until the scheduled date
On-Site Testing and InspectionQualified technicians visit the healthcare facility to perform visual inspections and functional safety tests according to IEC 62353 standards.Visual inspection (e.g., cables, connectors, casing), protective earth resistance testing, insulation resistance testing, patient leakage current testing, touch current testing, functional tests.Service Provider (Technicians)Varies based on the number and type of equipment (e.g., 1-5 days per site)
Data Analysis and ReportingTest results are analyzed, compared against acceptance criteria, and compiled into a comprehensive report.Reviewing raw test data, identifying deviations, documenting all findings, compiling the IEC 62353 test report.Service Provider (Technicians/Engineers)2-5 business days after testing
Corrective Actions (if necessary)If equipment fails to meet safety standards, recommendations for repairs or replacements are provided and, if agreed, corrective actions are undertaken.Identifying root cause of failure, recommending repairs or replacement, obtaining approval for corrective actions, performing repairs, re-testing.Service Provider, Healthcare FacilityVaries greatly depending on the nature of the corrective action
Certification and DocumentationUpon successful completion of testing and any necessary corrective actions, the equipment is certified as safe, and all documentation is provided.Issuing test certificates, providing copies of the full test report, labeling equipment with the test date and next due date.Service Provider1-2 business days after finalization
Follow-up and Record KeepingService providers maintain records of all tests performed, and healthcare facilities ensure these records are integrated into their equipment management system.Archiving test reports and certificates, scheduling future recurrent tests, responding to any post-test queries.Service Provider, Healthcare FacilityOngoing

IEC 62353 Recurrent Test Service Workflow in Niger

  • Inquiry and Initial Contact
  • Quotation and Service Agreement
  • Scheduling and Logistics
  • Pre-Test Preparation
  • On-Site Testing and Inspection
  • Data Analysis and Reporting
  • Corrective Actions (if necessary)
  • Certification and Documentation
  • Follow-up and Record Keeping

Iec 62353 Recurrent Test Service (In-service Testing) Cost In Niger

The cost of IEC 62353 recurrent testing services, also known as in-service testing, in Niger can vary significantly. Several factors influence the pricing, making it difficult to provide a single definitive cost. These services are crucial for ensuring the safety and performance of medical electrical equipment after it has been put into use, adhering to international standards and local regulations.

Pricing Factors:

  • Type and Complexity of Medical Equipment: Different devices have varying testing requirements. A simple device like a blood pressure monitor will be less expensive to test than a complex imaging system or a ventilator. The number of tests required by IEC 62353 for each device type is a primary cost driver.
  • Number of Devices to be Tested: Bulk testing often leads to a per-unit cost reduction. Larger healthcare facilities with many devices will likely negotiate better rates than smaller clinics.
  • Testing Location: Whether the testing is conducted on-site at the healthcare facility or at the testing provider's laboratory can impact costs due to travel, logistics, and potential disruption.
  • Testing Provider's Reputation and Expertise: Established, accredited testing laboratories with experienced technicians may command higher prices due to their reliability and quality of service.
  • Urgency of Testing: Rush services or testing required outside of normal business hours may incur additional charges.
  • Geographic Location within Niger: While Niger is a large country, the concentration of testing service providers might be higher in major cities like Niamey. Travel costs to more remote areas could increase the overall price.
  • Inclusion of Calibration Services: Some IEC 62353 testing packages may include basic calibration of certain parameters. If extensive or specialized calibration is required, it will add to the cost.
  • Annual Maintenance Contracts: Healthcare facilities often enter into annual contracts for regular testing and maintenance, which can offer discounted rates compared to one-off services.
  • Regulatory Compliance and Documentation: The rigor of the reporting and documentation provided can also influence pricing, especially if it needs to meet specific ministerial requirements.

Estimated Cost Ranges (in Nigerian Naira - XOF, Communauté Financière Africaine Franc):

Given the variability of factors, providing precise figures is challenging. However, based on general market trends for similar technical services in West Africa, the following ranges can be considered as an indicative guide. These are estimates and actual quotes should be obtained from service providers.

  • For a single, relatively simple medical device (e.g., patient monitor, infusion pump): Expect costs to range from XOF 30,000 to XOF 75,000 per device.
  • For a moderately complex medical device (e.g., ECG machine, defibrillator): The cost could range from XOF 60,000 to XOF 150,000 per device.
  • For highly complex medical equipment (e.g., diagnostic imaging systems, surgical lasers): Testing costs can be significantly higher, potentially ranging from XOF 150,000 to XOF 500,000 or more per device, depending on the specific system and the extent of testing required.
  • For bulk testing (e.g., a hospital with 50+ devices): The per-device cost is likely to be on the lower end of the respective ranges, with potential for further negotiation.

Note: These prices are indicative and can fluctuate. It is essential for healthcare facilities in Niger to solicit quotes from multiple accredited service providers to ensure competitive pricing and to fully understand the scope of services included.

Device ComplexityEstimated Cost Range (XOF)
Simple (e.g., BP Monitor, Infusion Pump)30,000 - 75,000
Moderate (e.g., ECG, Defibrillator)60,000 - 150,000
Complex (e.g., Imaging Systems, Surgical Lasers)150,000 - 500,000+

Key Pricing Factors for IEC 62353 Recurrent Test Service in Niger

  • Type and Complexity of Medical Equipment
  • Number of Devices to be Tested
  • Testing Location (On-site vs. Lab)
  • Service Provider's Reputation and Accreditation
  • Urgency and Scheduling Requirements
  • Geographic Location within Niger
  • Inclusion of Ancillary Services (e.g., Calibration)
  • Contractual Agreements (e.g., Annual Maintenance)
  • Level of Documentation and Reporting

Affordable Iec 62353 Recurrent Test Service (In-service Testing) Options

Ensuring medical equipment safety through IEC 62353 recurrent testing (in-service testing) is a critical regulatory requirement and vital for patient well-being. Finding affordable options without compromising on quality is a common challenge for healthcare facilities. This service ensures that medical electrical equipment continues to meet safety standards after installation and throughout its operational life. We offer flexible service packages and cost-saving strategies to make compliance manageable and economical.

Value Bundle NameIncludesTypical Cost Savings (%)Ideal For
Basic Compliance BundleIEC 62353 recurrent testing for a defined number of essential equipment types, digital reporting.5-10%Smaller clinics, budget-conscious facilities with standard equipment.
Standard Efficiency BundleIEC 62353 recurrent testing for a larger equipment inventory, on-site service, basic preventive checks, extended reporting features.10-15%Medium-sized hospitals, facilities requiring on-site convenience and some added value.
Premium Management BundleComprehensive IEC 62353 recurrent testing across all equipment categories, on-site or off-site flexibility, proactive maintenance scheduling, detailed asset management reports, priority scheduling.15-20%+Large healthcare systems, facilities with complex equipment portfolios and a focus on proactive risk management.
Multi-Year PartnershipCustomizable testing frequency, dedicated account manager, significant discounts on bundled services, early access to new service offerings.Up to 25%+Any facility committed to long-term safety and compliance, seeking predictable costs and a strategic partnership.

Affordable IEC 62353 Recurrent Test Service Options

  • On-Site Testing: Our technicians visit your facility, minimizing downtime and logistical challenges for your equipment.
  • Off-Site Testing: For non-critical equipment or when significant downtime is acceptable, we can perform testing at our specialized facility, often allowing for bulk processing and economies of scale.
  • Multi-Year Contracts: Committing to longer-term service agreements unlocks significant discounts and predictable budgeting.
  • Managed Service Packages: Integrate IEC 62353 testing with other planned maintenance activities for comprehensive and cost-effective equipment management.
  • Tiered Service Levels: Choose from basic, standard, or premium packages based on your facility's specific needs and budget constraints.
  • Bulk Testing Discounts: The more equipment you have tested at once, the lower the per-unit cost.
  • Proactive Maintenance Integration: Combine recurrent testing with preventive maintenance to identify and address potential issues before they lead to failures or necessitate more expensive repairs.
  • Digital Record Keeping: Receive comprehensive digital reports, reducing administrative overhead and ensuring easy retrieval of compliance documentation.

Verified Providers In Niger

Ensuring access to quality healthcare is paramount, especially in regions where reliable and trustworthy providers are crucial. In Niger, identifying healthcare facilities and professionals with verifiable credentials is key to making informed decisions about your health and well-being. Franance Health stands out as a platform dedicated to connecting individuals with such verified providers, offering a range of benefits that make them the best choice for your healthcare needs.

FeatureFranance Health VerificationBenefit to Patients
Licensing and CertificationMandatory verification of all relevant medical licenses and certifications.Ensures providers are legally qualified and possess the necessary formal training.
Educational BackgroundVerification of degrees and diplomas from accredited institutions.Confirms providers have a solid academic foundation in their medical discipline.
Professional ExperienceReview of work history and references where applicable.Provides insight into a provider's practical skills and track record.
Ethical ComplianceAdherence to established codes of conduct and ethical guidelines.Promotes patient-centered care and builds trust through professional integrity.
Specialty ConfirmationVerification of credentials specific to chosen medical specializations.Guarantees access to qualified specialists for targeted health needs.

Why Franance Health Credentials Represent the Best Choice:

  • Rigorous Vetting Process: Franance Health implements a stringent verification process for all its listed providers. This includes thorough checks of medical licenses, educational qualifications, professional certifications, and adherence to ethical standards. This ensures that only competent and legitimate healthcare professionals are included on their platform.
  • Patient Safety and Trust: The verification process directly translates to enhanced patient safety. By choosing a Franance Health-verified provider, you can be confident that you are receiving care from individuals who have met established benchmarks for expertise and practice. This builds trust and reduces the anxiety associated with seeking medical attention.
  • Access to Specialized Care: Franance Health often categorizes providers based on their specializations, making it easier for patients to find the right expert for their specific medical condition. Their verification process extends to ensuring these specialists have the necessary credentials in their chosen fields.
  • Transparency and Information: Franance Health provides comprehensive profiles of their verified providers, including their areas of expertise, experience, and sometimes even patient reviews (where applicable and ethically permissible). This transparency empowers patients with the information they need to make educated choices.
  • Commitment to Quality Standards: The credentialing process employed by Franance Health is designed to align with international best practices for healthcare provider verification. This commitment to high standards ensures that patients in Niger have access to a level of care that meets global expectations.
  • Facilitating Informed Decisions: By presenting clearly verified providers, Franance Health simplifies the decision-making process for individuals seeking healthcare. It eliminates the guesswork and allows patients to focus on their recovery rather than worrying about the credibility of their caregiver.

Scope Of Work For Iec 62353 Recurrent Test Service (In-service Testing)

This Scope of Work (SOW) outlines the requirements for providing recurrent in-service testing (IST) services for medical electrical equipment in accordance with IEC 62353:2014+A1:2020. This service ensures the continued safety and performance of medical devices after they have been put into use. The SOW details the technical deliverables, standard specifications, and reporting requirements.

Test ParameterStandard Reference (IEC 62353)Acceptance Criteria (General Guidance)
Visual InspectionClause 5.2No physical damage, legible labels, secure connections, proper grounding.
Protective Earth ResistanceClause 5.4Typically ≤ 0.1 Ω (refer to specific standards for exact values)
Enclosure Leakage CurrentClause 5.5Class I: ≤ 0.5 mA (3.5 mA for permanent wired), Class II: ≤ 0.1 mA (refer to specific standards for exact values)
Patient Leakage Current (AP)Clause 5.6.1Type B: ≤ 0.1 mA, Type BF: ≤ 0.1 mA, Type CF: ≤ 0.01 mA (Refer to specific standards for exact values and single-fault conditions)
Patient Auxiliary Current (AP)Clause 5.6.2Refer to specific standards for exact values and single-fault conditions.
Insulation ResistanceClause 5.7Typically ≥ 1 MΩ (refer to specific standards for exact values)
Functional PerformanceClause 5.8Device operates as per manufacturer's specifications and intended use.

Scope of Work for IEC 62353 Recurrent Test Service (In-Service Testing)

  • 1. Introduction & Purpose: To define the framework and requirements for recurrent in-service testing (IST) of medical electrical equipment to ensure ongoing safety and compliance with IEC 62353.
  • 2. Service Objectives:
  • ["Verify the electrical safety of medical devices.","Confirm the functional performance of medical devices.","Identify potential hazards and risks introduced during operational use.","Ensure continued compliance with regulatory requirements.","Provide accurate and comprehensive documentation of test results."]
  • 3. Applicable Standards:
  • ["IEC 62353:2014+A1:2020 - Medical electrical equipment – In-service inspection and testing after repair and before use.","Relevant manufacturer's service manuals and specifications.","Local regulatory requirements for medical device safety and maintenance."]
  • 4. Scope of Testing: The service shall cover the recurrent in-service testing of specified medical electrical equipment. The exact list of equipment to be tested will be provided in a separate annex.
  • 5. Testing Procedure:
  • ["All tests will be performed by qualified and competent personnel.","Testing will be conducted during planned maintenance windows to minimize disruption to clinical operations.","Testing will be performed using calibrated test equipment traceable to national or international standards.","The testing methodology will adhere strictly to the procedures outlined in IEC 62353, including but not limited to:",["Visual Inspection","Protective Earth Resistance","Enclosure Leakage Current","Patient Leakage Current (Applicable Parts A, B, CF)","Patient Auxiliary Current","Insulation Resistance","Functional Performance Tests (as specified by manufacturer)"],"Where applicable, tests will be performed in both normal and single-fault conditions."]
  • 6. Equipment Requiring Testing: A detailed inventory of the medical electrical equipment requiring testing, including model numbers, serial numbers, and location, will be provided as an attachment to this SOW.
  • 7. Test Equipment: The service provider shall supply all necessary calibrated test equipment required to perform the IEC 62353 compliant tests. A list of primary test equipment used will be provided in the final report.
  • 8. Reporting Requirements: Upon completion of the testing, the service provider shall deliver a comprehensive test report for each tested device. The report shall include, at a minimum:
  • ["Unique identification of the tested device (Model, Serial Number, Asset Tag).","Date of testing.","Name and signature of the testing technician.","List of test equipment used with calibration dates.","Results of all tests performed, clearly indicating PASS/FAIL status for each parameter.","Any deviations from the standard test procedure and the reasons for such deviations.","Recommendations for corrective actions or further investigation if any issues are identified.","A summary of the overall condition of the device.","The report shall be provided in both electronic (PDF) and hardcopy format."]
  • 9. Non-Conformance and Corrective Actions: In the event of a device failing any of the safety or performance tests, the service provider shall immediately notify the designated contact person. Depending on the nature of the failure and prior agreement, the service provider may be required to:
  • ["Attempt minor corrective actions if within their capability and authorized.","Provide a detailed recommendation for repair or replacement.","Isolate the non-conforming device to prevent its use."]
  • 10. Project Timeline: The testing shall be completed within the agreed-upon timeframe as specified in the project schedule. This SOW assumes regular access to the equipment during the defined testing periods.

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) provided by [Your Company Name] (hereinafter referred to as "Provider") to [Client Company Name] (hereinafter referred to as "Client").

Service LevelDescriptionGuaranteed Response TimeUptime Guarantee
Standard Recurrent Testing (Scheduled)Routine testing performed during agreed-upon maintenance windows or scheduled downtimes.Within 24 hours of receiving a confirmed test request and scheduling confirmation.99.5% Availability of testing technicians and equipment during scheduled testing windows.
Priority Recurrent Testing (On-Demand)Testing required outside of scheduled maintenance due to immediate operational needs or compliance deadlines.Within 8 business hours of receiving a confirmed, urgent test request.99.0% Availability of testing technicians and equipment during the response window for priority requests.
Emergency Recurrent Testing (Critical Device Failure)Testing required for critical medical devices that have failed or are suspected of failure, posing an immediate risk.Within 4 business hours of receiving a confirmed emergency test request.100% Availability of testing technicians and equipment to initiate diagnosis and testing within the response window. Uptime for the device itself is not guaranteed by this SLA, only the rapid availability of testing.
Reporting AvailabilityAccessibility and delivery of completed test reports.Within 48 business hours of test completion for standard and priority tests, and 24 business hours for emergency tests.99.9% Availability of the reporting system and personnel for report generation and distribution.

Service Scope

  • The Service includes scheduled and on-demand recurrent testing of medical devices in accordance with IEC 62353 standards, performed while the devices are in operational use or during scheduled maintenance windows.
  • Testing will be conducted by certified technicians using calibrated equipment.
  • Reporting will be provided detailing test results, any identified deviations, and recommended corrective actions.
In-Depth Guidance

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