Testing and documenting compliance to the medical device and laboratory equipment safety standards
Medical Electrical Equipment standards: IEC 60601-1 with national differences, etc. : US (AAMI ES), Europe (EN), Canada (CSA)
Laboratory Equipment standards: IEC 61010-1 with national differences, etc. : US (UL), Europe (EN), Canada (CSA)
Accredited Compliance Reports
The most effective path to demonstrating compliance to the international safety and essential performance standards, used to place devices on the international market.
Includes equipment evaluation, required documentation review, device testing, and report, for demonstrating compliance to standards. The IECEE-published TRF (Test Report Form) is the international report format used to document compliance to IEC standards. These reports are typically referred to as Compliance Reports, CB Style Reports, or FDA 510(k) Testing Reports.
For medical devices, the report covers the IEC 60601-1 base standard, applicable Collateral and Particular standards, as well as national differences. See IEC 60601-1 National Differences list of standards.
For Laboratory Equipment, the report covers the IEC 61010-1 base standard and applicable Particular standards.
Preliminary Evaluations are the first step in the full evaluation process, which are typically pulled out front as a separate project. They are a design and documentation reviews, to identify and address compliance issues and determine the full project plan. They consist of 1 day at the client’s facility or at MECA (travel expenses are an additional cost, if done at client’s facility). To greatly reduce the full evaluation project time, we strongly suggest considering a Preliminary Evaluation as the first step.
Limited Testing with a Letter Report
For clinical trials and other premarket use, a limited evaluation and testing with a Letter Report may be adequate. A review of the intended use with a MECA Engineer will determine the minimum evaluation and testing requirements needed. A Letter Report is then generated, which summarizes what was evaluated, such as construction, labels, IFU (manual), and the testing.
CB Reports (Certified Body Reports) are used to facilitate mutual recognition (reciprocal acceptance) of test results to obtain certification or approval at national levels around the world.
Using a CB Report, clients can attain Certification Marks from many different Certification agencies around the world that participate in the CB Scheme.
CB Reports are valid for three years from the issue date.
Revise or update an existing compliance report (MECA, UL, TUV Rheinland, or Intertek). Revisions include changes to construction, software, documentation, or markings to the device or system. To determine the scope of work for revisions, we need to know the following items:
- Who issued the report (lab/agency)
- The changes to the device (components, layout, construction, software, documentation, markings, etc.)
- For component changes, the existing and new component specifications to determine what testing may be applicable
MECA offers compliance engineering expertise to answer applicable standard requirement questions. This can be used to reduce the cost and time of redesign, by identifying noncompliances earlier in the design process. We offer two options for compliance Services:
- Two Months Compliance Services (up to 8 hours)
- Six Months Compliance Services (up to 16 hours)
- One year Compliance Services (up to 40 hours)
3rd Party Certification Partnerships
Third Party NRTL Safety Certification Marks (UL, TUV Rheinland, ETL Intertek, etc.) are used to show that the equipment complied with its applicable standards when it left the manufacturing facility. These are typically required in the US and Canada by hospitals, clinics, and other medical facilities, as well as, stores and pharmacies that sell home use medical devices.
A NRTL is a Nationally Recognized Testing Lab, which is controlled and audited by OSHA. MECA partners with Underwriters Laboratories (UL Mark), TUV Rheinland (TUV Mark), and Intertek (ETL Mark) to provide 3rd Party Certification Marks. To obtain these Certifications, the respective agency reviews our report and, upon approval, provides the authorization to apply their Mark. MECA can also assist with obtaining other 3rd Party Certifications utilizing a CB Report (see above).
We conduct testing according to the standards listed in our scope(s) of accreditation, in accordance with ISO 17025 and the applicable standards (e.g. IEC 60601-1). In addition, we conduct custom testing per manufacturer’s specifications needs. Examples of testing we can perform include the following:
- Leakage current, dielectric (hypot), temperature, grounding continuity, transformer short/overload, etc.
- Environmental conditioning, limited to temperature and humidity cycling chambers
- Unique testing for specialized equipment (electrosurgical devices, infusion pumps, ECG and multiparameter patient monitors)
- Ingress Protection (IPXX testing), fluid flow rate (infusion pumps), Loading, Force, threshold, Impact, etc.
- Sound/alarm testing, using ISO 3744 hemi-anechoic (free field) sound chamber (SPL, harmonics, timing)
Provide your team with the tools necessary to comply with the required standards
Private 2 Day Seminar at Client’s Facility
- IEC 60601-1 with National Differences (US, AAMI ES 60601-1, Canada, CSA C22.2 No. 60601-1, Europe, EN 60601-1)
- Customized to Client’s equipment and needs
Copyrighted standards are not included in the material provided
1 Day Limited Seminar
Does not cover all the standard requirements of the full seminar, but can be customized to meet your needs.
Typical Seminar Agenda
- Regulatory Overview and Role of Standards
- Introduction to IEC 60601-1, Overview of Major Differences from Edition 2 to 3.1
- Risk Management, Overview of Usability Engineering, Alarms, Programmable Systems
- General Requirements/Classifications/Basic Terminology/Marking and Labelling
- Protection Against Electrical Shock – Leakage Current and Applied Parts
- Protection Against Electrical Shock – Designing Electrical Insulation, Insulation Diagrams
- Continuation of Insulation Diagrams and Required Spacings from Day 1
- Verifying Electrical Insulation
- Medical Electrical Systems
- Protection Against Mechanical Hazards
- Protection Against Thermal and Other Hazards
- Component Requirements
The next public seminar date is pending.