LNE services designed for medical electrical devices
LNE offers an extensive range of electrical safety tests in accordance with the IEC 60601-1 standard
intended for medical electrical devices or systems, as well as expert assessment, technical support
and techno-regulatory assistance, standards and regulations watch and training services.
LNE offers the following tests:
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Electrical safety tests in accordance with the IEC 60601-1 standard, covering medical
electrical devices and medical electrical systems
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Mechanical tests on MDs: static and dynamic tests (fatigue, impact)
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Mechanical tests on packaging materials (falls, impacts, vibrations, jolts)
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Simulation of transport constraints
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Weathering and ageing resistance tests
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Physicochemical tests
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Chemical analyses (example for IMPs: shell salting out, silicone release)
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Fire tests
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Acoustic tests, etc.
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Assessment, Technical Support and Techno-Regulatory Assistance
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Standards and regulations watch
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Training
Additional collateral standards may apply to certain product types:
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IEC 60601-1-2:Electromagnetic Compatibility
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IEC 60601-1-3:Diagnostic X-ray equipment
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IEC 60601-1-6:Usability (2007/47/EC directive)
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IEC 60601-1-8:Alarm systems in medical electrical equipment and medical electrical systems
The collateral standards supplement the general standard covering the characteristics that are not
fully covered.
For certain types of equipment, these rules will be supplemented or modified by the special
requirements of one of more special part 2 standards, which must be read in conjunction with the
part 1 rules:
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IEC 60601-2-18:Endoscopic equipment
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IEC 60601-2-22:Surgical, cosmetic, therapeutic and diagnostic laser equipment
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IEC 60601-2-24:Infusion pumps and controllers
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IEC 60601-2-37:Ultrasonic medical diagnostic and monitoring equipment
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IEC 60601-2-54:X ray equipment
These special standards contain particular requirements that can modify, replace or cancel the
requirements contained in the general standard.
The CB Scheme programme
This programme, in which LNE participates, is an international system for mutual acceptance of test
reports and certificates dealing with the safety of electric and electronic products (components,
equipment, products) between member National Certification Bodies.It thus serves to avoid
repeating the compliance evaluations required by each country.The CB Scheme is based on the use
of CB Test Certificates, providing evidence that the representative samples of a product submitted
for testing meet the requirements of applicable IEC (International Electrotechnical Commission)
standards.
In the context of the CB Scheme international agreements, LNE is recognised by the IECEE both as a
National Certification Body and as a Certification Body and Testing Laboratory (CBTL).
Medical electrical device manufacturers can either use LNE certificates to market their products in
the 52 signatory countries, or submit the certificates obtained in other countries to LNE as part of
their application for CE marking or NF medical marking.
The North American market
LNE has set up an agreement with the Canadian body QPS Evaluation Services, accredited as an NRTL
(National Recognised Testing Laboratory) by the Canadian and American authorities, such that the
Laboratory's electrical safety tests can be used for QPS certifications.This agreement enables LNE's
customers to market their products more easily in American and Canadian markets.
Certification process
- Complete tests as per applicable IEC safety standards including US and Canadian deviations.
- Prepare CB reports and certificates.
- Sign forms by the customer and LNE (as the agent acting between the customer and the NRTL).
- Send all reports, the certificate and forms to QPS, as well as the application for marking with the
QPS logo.
- QPS initiates the audit of the manufacturing site(s): the purpose of the audit is to ensure that the
resources used to manufacture products identical to that evaluated are in place.As an example,
procurement procedures are controlled.Where it is required, inspection devices at the end of the
chain (dielectrometry) are checked.Depending on the location of the production site, audits will be
carried out by LNE employees, previously trained by QPS.
- QPS issues the mark: periodic audits of production sites are conducted every 3 months (whether or
not there was production).
Maintain the mark: the mark is maintained as long as annual costs are paid and inspections made
and as long as non-compliances are not identified during audits or in the market.In the event of
changes to technical requirements or a new edition of the standard, for example, the customer must
re-submit the product for re-evaluation.
The Brazilian market
LNE is accredited by INMETRO as a PCB (Product Certification Body) for assessing the compliance of
tests performed on products according to Brazilian standards, and may replace INMETRO to directly
deliver the compliance certificates required to register medical electrical devices, a mandatory
procedure for bringing its products to the Brazilian market.
The INMETRO - LNE certificate is issued based on electrical safety tests conducted at the Laboratory
and in the manufacturer's plant on each device unit, and on an audit of the manufacturer's quality
system.
Operating procedure
INMETRO certificates are issued for a 5-year cycle (1 initial audit and 4 follow-up audits) and cover
the following services:
- Device feasibility study,
- Documentary audit to check that the product conforms to applicable standards, with accompanying
report,
- Submission to a review committee,
- Issuing a certificate.
The service also includes an annual on-site audit combined with the ISO/EC audits.
ISO 13485 certification is mandatory for and complementary to INMETRO certification.
Consequently, if the company is already ISO 13485 certified, LNE shall audit the ancillary
requirements essential for obtaining INMETRO certification.If this is not the case, LNE offers initial
ISO 13485 certification, followed by INMETRO certification.