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IEC 60601-1
Medical Equipment Compliance,
Certification, and Regulatory Services and Information

Medical Equipment Compliance Associates, LLC

Accredited Compliance Reports








The least expensive, fastest path to demonstrating compliance, required to place your device on the international market

Project covers medical equipment evaluation, safety testing, and report, for demonstrating compliance to standards.
The IECEE-published TRF (Test Report Form) is the international report format used to demonstrate 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 deviations: United States (AAMI 60601-1), Canada (CSA C22.2 No. 60601-1), and European Union Countries (EN 60601-1).
For Laboratory Equipment, the report covers the IEC 61010-1 base standard and applicable Particular standards.
The TRF includes all the clause verdicts (Pass, N/A, or Fail) with remarks, test data, critical components, risk management documentation, and attachments (photos, markings, user manual, etc.).

The international function of Compliance Reports:
USA: Demonstrate compliance to the FDA recognized consensus standards, for 510(k), PMA, as well as obtaining an NRTL Mark.
Canada: Demonstrate compliance to the Health Canada and SCC (Standards Council of Canada) recognized standards.
European Union: Demonstrate compliance to the required standards in the Official Journal for your Notified Body, for CE Marking, under the MDD (Medical Device Directive). The new MDR (Medical Devices Regulation) will be required by May 26th 2020.
Australia: The Australian TGA (Therapeutic Goods Administration) accepts CE Marking, per European MDD requirements.
Brazil: Demonstrate compliance for INMETRO Certification. Testing MUST be conducted by ilac Accredited Lab, within 2 years.
Japan: Demonstrate compliance to the Japanese Ministry of Health & Welfare recognized standards with National Differences.
China: The CFDA (China Food and Drug Administration) is currently only accepting 2nd Edition of IEC 60601-1, and all testing
must be re-conducted by an authorized test lab in China. In some cases, testing may be re-conducted outside of China when witnessed by an authorized CFDA representative. MECA has conducted this witnessed CFDA testing for multiple projects.

List of IEC 60601-1 National Standards and Countries (per CB Scheme)

Limited Testing With a Letter Report








For clinical trials and other premarket use of medical devices

For clinical trials and other premarket use, a limited evaluation and testing with a Letter Report may be adequate.
A review of the premarket 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. It includes the construction, labels, manual, risk management review (as applicable), and the testing that was conducted.

NRTL Safety Marks for the US and Canada








To sell into most hospitals and healthcare facilities in the US and Canada, a Safety Mark is needed

Third Party NRTL Safety Marks (UL, TUV Rheinland, ETL Intertek, TUV SUD, CSA, 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, for selling to hospitals, clinics, and other places that require a NRTL Safety Mark for equipment used at their facility.

A NRTL is a Nationally Recognized Testing Lab, which is controlled and audited by OSHA.
MECA works with Underwriters Laboratories (UL Mark), TUV Rheinland (TUV Mark), and Intertek (ETL Mark).
For these Safety Marks, the agencies review the reports and test data that MECA generates, and after any review comments are addressed, they issue the authorization to apply their applicable Safety Mark.
For other NRTL Marks (TUV-SUD, CSA, SGS, etc.), MECA can use a CB Report to get these NRTL Marks (see CB Reports below).

To apply a NRTL Mark to your equipment, OSHA requires the NRTL to conduct ongoing production inspections, either 2 or 4 times a year, to verify the equipment being manufactured is the same as what was evaluated and tested. These are typically referred to as "factory inspections".

We handle UL Classification, TUV Certification, and ETL Intertek certification from start to finish.
By performing preliminary evaluations, providing compliance services, conducting testing at MECA's laboratory, writing the reports, and working with the NRTL reviewer, we can decrease the time that it takes you to obtain NRTL Safety Marks for your device.

CB Reports








MECA is a CB Testing Laboratory, under the IECEE CB Scheme

CB Reports (Certified Body Reports) are used to conduct an evaluation, testing, and report with one agency, and exchange the data with another agency, to attain their certification mark. While a CB Report is not required for entry into any international markets, the term "CB Report" has become a term for a complete report in the IECEE format, recognized internationally.

Using a CB Report, clients can attain Safety Marks from any US or international agency under the the CB Scheme, without retesting.

CB Reports are valid for three years from issue date, and have additional critical component requirements (such as requiring a CB Report for the power supply used in the equipment). The process and testing also require adherence to CB Scheme and IEC rules.

Compliance Services








Ensure that your device or design complies with the applicable standard requirements early in the process

We are happy to help you with your compliance questions.
This may include the requirements in the standards and how they affect your device design and component selection,
interpretations of those requirements, or international regulatory requirements for getting your device on the market.

This is used to reduce the cost and time of redesign by identifying noncompliances earlier in the design process

We provide the first 15 minutes free for new clients with compliance questions.
To cover additional time to address your questions, we offer two options:
   - Two months, with up to 8 hours compliance services
   - Six months, with up to 16 hours compliance services

To initiate these immediately, complete the PayPal checkout on our Quote page.
To receive a quote and use a PO, please use the quote submission page, and specify if you would like the 2 or 6 month option.


We also offer custom compliance services projects for specific needs

This may include reviewing insulation diagrams or risk management documentation, construction reviews, meetings, etc.
To receive a quote for custom compliance services, please use the quote submission page, and specify your needs.

Seminars, Training








Provide your team with the tools necessary to comply with the required standards

Online Seminar Course:
IEC 60601-1 Ed 3.1 Compliance Program Certificate

Estimated Learning Duration of the Program: 1-2 weeks
Provided by WMDO (World Medical Device Organization)

Program Description:
Developed by Brian Biersach, this comprehensive five course program provides you with
an in-depth review of the IEC 60601 edition 3.1 requirements, offering reference to numerous
collateral and other related standards, including ISO 14971.

Throughout the program a comprehensive comparison is provided between the previous
2nd edition up through the current 3rd edition, including amendment 1.

The extensive information contained in this program offers learners several examples and
specific situations for different types of medical electrical equipment as well as practical
insight for professionals.

For a list of the topics covered, and to purchase this online seminar course,
see the WMDO course page

Preliminary Evaluations

Preliminary Evaluations are the first part of the full evaluation process, 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 the 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.
This is NOT an additional cost, since the full evaluation project includes this first step.

See the main page for a description of the Preliminary Evaluation and full project steps.

Custom Testing








We conduct electrical, mechanical, sound, and other testing, to meet your needs

Testing is conducted and documented under our ISO 17025 laboratory accredited procedures.
Some of the testing that we conduct includes 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)
- Water Ingress (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)
- Cleaning/disinfection testing, for accelerated life testing of agents specified in user manuals

Report Revisions








Revise or update an existing report (MECA, UL, TUV Rheinland, or Intertek)

These revisions to the report address construction, software, or documentation changes to the device or system.
Based on the description of the changes, this may be a paperwork revision only, or may require testing or documentation review.
To determine the scope of work for these 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, we need the existing and new component specifications, to determine what testing may be applicable

Gap Analysis








Documentation of differences between standard editions

Gap Analysis documentation from second to third edition or between editions of Collateral or Particular standards.
The report documents all of the differences between the standard editions.
For equipment-specific gap analysis projects, it also addresses the applicability of those differences to the device/system.
This does not include testing, unless requested specifically.