MECA - Home Page: Information on UL 60601-1, IEC 60601-1, EN 60601-1 medical standards, UL Classification, UL Mark, testing, certification outsourcing

- Speed Your Medical Equipment to Market -

Thank you for visiting MECA's website for the information and resources you need

SEE NEW JOB POST BELOW
(Technical or Engineering Position, Experience with Medical Standards and testing required)

MECA Team: Heidi Kramer, Paul Dillon, Jeremi Peck, Brian Biersach, Paula Biersach

PLEASE feel free to email us if you have general or specific questions.
For quickest response, use info@60601-1.com
See contact page for employee phone numbers and emails

MECA Experience and Expertise
• CB Testing Laboratory, under the IECEE CB Scheme for medical equipment (ACTL)
• UL Third Party Test Data Program for medical devices
• TUV Rheinland Qualified Laboratory for medical devices
• ISO 17025 and ISO 9000 compliant Quality System for Testing Labs
  • US Technical Experts for AAMI on IEC/ISO Working Group Committees for International Medical Standards Writing

Website Index
  • See the SERVICES Page for the different services MECA offers
   - Evaluation, Testing, Compliance Reports for FDA 510(k) Clinical Trials, and PMA, as well as for CE Marking under the MDD
   - Speeding the process of obtaining your third party safety marks (UL, TUV, etc.) and lowering your overall evaluation costs
   - Training and Compliance Engineering Services
  • See the TESTING Page for photos of the lab and testing procedures
  • See the DOWNLOADS Page for FREE Document files for download:
   - 60601 Evaluation Package: Checklist for the Medical standards UL/EN/IEC 60601 with requirements and national deviations,
   - Test data sheets, Critical Component Guide, Medical Device marking and user manual checklist, and more
  • See the ABOUT MECA Page for Certifications, Certificates, and Employee Biographies
  • See the CONTACT Page for emails, phone numbers, address, and directions to MECA
  • See the INFORMATION Pages for Frequently Asked Questions (FAQ)
    - Where do I get copies of these standards?
    - What are the Leakage Current limits for medical equipment in the US?
   - When will compliance to the 3rd Edition of IEC 60601-1 be required?
   - Marketing your medical device in the European Union (CE Marking under the MDD - Medical Device Directive) and the rest of the world
  • See the SEMINARS Page for information regarding seminars and training
  • See the LINKS Page for useful links to compliance and certification resources
  • See the REQUEST INFO/QUOTE Page for an on-line form to submit questions and request quotes

We have assembled the top medical equipment compliance specialists in the field to provide full compliance services to our clients in a cost-effective manner.

Why do you need to meet the UL60601-1 / IEC60601-1 / EN60601-1 / CSA C22.2 No. 601.1 safety standards ?

  - The FDA requires safety performance testing.
     IEC 60601-1 + US deviations (UL 60601-1) is the key FDA recognized consensus standard for medical electrical equipment.
     Without evidence that you meet the applicable standards (a Third Party Compliance Report), you will not be able to establish that you meet these required standards

  - In the US, the Occupational Safety and Health Administration (OSHA) requires a safety mark from a National Recognized Testing Laboratory (NRTL) for use in a public facility.
     This is specified in OSHA Standards Part 1910, Subpart S-Electrical, Sec. 1910.399.
     *While required, this is not typically enforced in the US
     (NRTLs include UL, TUV Rheinland, TUV SUD, CSA, Intertek/ETL, and others)

- Most Local AHJs (Authorities Having Jurisdiction) and nearly all hospitals and clinics in the US require 3rd party safety marks on equipment to be purchased.
     These safety marks rely on compliance with the UL 60601-1 standard in the US.
  - The CE Mark is required on a product to place it on the market in the European Union.
     For medical equipment, the CE Marking requirements are in the MDD (Medical Device Directive), which is European Law.
  - The MDD requires documentation of compliance to the applicable safety standards (such as EN 60601-1).
     You may not legally place a medical device on the market in the European Union without meeting the Medical Device Directive requirements.
     For all medical equipment, except (per MDD) Class 1, non-measuring, non-sterile, an Audit by a Notified Body (from Europe) is required before the CE Mark may be placed on a medical device.
     The CE Mark will have a 4-digit number under it, denoting the Notified Body used.

  - By meeting the requirements of the IEC60601-1 series of standards with National Deviations, you officially meet the requirements of most of the world's nations, and unofficially meet the requirements of all.
     This opens your marketing potential to the entire world market.

UPDATES:

2010/01/08 - Job Post - MECA is expanding this year in Oak Creek, Wisconsin!

We are looking for individuals with various levels of experience in the field of medical equipment compliance
(Engineers or technically competent individuals with experience in medical device testing and the standards).
Please e-mail a current resume including detailed educational and employment history, as well as experience to bb@60601-1.com.
You must also include your approximate salary/wage requirements to be considered.

2010/01/02 - FDA Acceptance of 3rd Edition of IEC 60601-1: 2005 (US)

The FDA has still not officially accepted the IEC 60601-1 3rd Edition, nor the US version, ES 60601-1 (published by AAMI).
It is intended on being accepted soon, but no date has yet been provided (it has been "soon" since November, 2007).
The FDA has actually accepted several medical devices evaluated only to the 3rd Edition, but required a 3rd to 2nd Edition gap analysis (as we have been told by clients).

2010/01/01 - UL 544 & UL 187 Are Now Withdrawn

Any Medical Products evaluated only to UL 544 or UL 187 can no longer apply a UL Mark.
This means if your company has a medical device with a "UL Listed" Mark, you can no longer apply it.
All Medical Devices must be re-evaluated to UL 60601-1 (or ES 60601-1) to apply the UL Classification Mark.
Please be sure that none of your devices are still having the UL Listed Mark applied.

2009/11/04 - MECA is now a TUV Rheinland Qualified Laboratory for the Medical Standards

We are pleased to announce that MECA is now a Qualified Laboratory for TUV Rheinland, under the Partner Test Laboratory Program.
This allows us to offer TUV Certification services to our clients.
MECA conducts the evaluation, testing, and writes the report, and TUV conducts the Reviews and provides the authorization to apply their safety mark.
See the ABOUT page for Certificate

2009/07/06 - EN 60601-1:2005 Date of Conformity Recommendation (Europe)

During the recent CENELEC TC 62 meeting on June 19, 2009 in Brussels, the Technical Committee members agreed with the proposal outlined in document 1008/INF and accepted June 1, 2012 as the recommended date of presumption of conformity for third edition of IEC/EN 60601 (for Europe).
This 2012 date would extend the date by which manufacturers of electromedical equipment would need to show conformity to EN 60601-1:2005.
In order to become official, the final decision will need to be rendered by the CENELEC Technical Board.
- The FDA has still not recognized the 3rd Edition of IEC 60601-1.

2009/06/22 - Paul Dillon Has Joined MECA as Our New Engineering Lab Tech.

Paul joins us from GE Healthcare, and has 25+ yeas experience with medical equipment design and testing experience.
With Paul's help, we are continuing to work on reducing the backlogs that are currently abundant in the field of medical certification.

OLDER RELEVANT INFORMATION:

2008/11/17 - MECA is now a CB Testing Laboratory (ACTL) for the Medical Category, under the CB Scheme

Medical Equipment Compliance Associates, LLC has been accepted by the IECEE as an ACTL, associated with Underwriters Laboratories, Inc.
This allows MECA to conduct testing under the medical category (IEC 60601-1 and specified Collateral and Particular standards) for the CB Scheme.
See the ABOUT page for Certificate

2008/10/16 - CSA Has Extended the Recognition of IEC 60601-1, Second Edition to June, 2012 (Canada)

Health Canada will continue to accept declarations of conformity to the Second Edition of IEC 60601-1 until June, 2012.
After June, 2012 Health Canada intends to only accept declarations to the Third Edition of IEC 60601-1, and the related collateral and particular standards.

We will need to see when the Particular Standards are published, but they will likely all be revised to be harmonized with the 3rd Ed. by the end of 2010, giving a two year phase-in time for them, which is typical for standard revisions.

2007/09/05 - MDD (Medical Device Directive) Amended

MDD 93/42/EEC (Medical Device Directive) has been in place since June 14, 1998. It was amended on September 5, 2007.
The consolidated directive will become mandatory on March 21, 2010.
The directive establishes essential requirements and harmonized standards for the manufacture, design, and packaging of medical devices.
A medical device is defined as any instrument, apparatus, appliance, software, material or other article.
This includes if this device is used alone or in combination with software necessary for its proper application intended by the manufacturer to be used for human beings in the purpose of:
    * diagnosis, prevention, monitoring, treatment or alleviation of disease
    * diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
    * investigation, replacement or modification of the anatomy or of a physiological process control of conception and which does achieve its principal intended action by pharmacological process, immunological or metabolic means but may be assisted in its function by such means.

The Medical Device Directive calls for all manufacturers who distribute in the European Economic Area to comply with essential requirements that benefit the safety of those in the EEA. The devices must be designed and manufactured in such a way that as they are used by patients, they will in no way compromise the health of the patient. Other areas included and outlined in the directive are requirements regarding design and construction, materials used in the production of the device, and reduction of risk as far as possible to the patient. The directive ensures that the performance of the device promised by the manufacturer is achieved. The Medical Device Directive is necessary due to the differences of safety, health protection, and performance characteristics among Member States and thus causes barriers to trade within the Community. The harmonized standards of the Medical Device Directive allow for free movement within the market.

2007/08/28 - MECA is now under the UL Third Party Test Data Program (TPTDP), for the Medical Category

We are pleased to announce that MECA is now under the full Third Party Test Data Program for Underwriters Laboratories, Inc.
This allows us to offer UL Classification and Recognition services to our clients.
MECA conducts the evaluation, testing, and writes the report, and UL Reviews the reports and provides the authorization to apply their safety mark.
Prior to this, a level of required UL test witnessing was required per project.
See the ABOUT page for Certificate

2005/12/15 - IEC 60601-1, 3rd Edition Published.

The Third Edition of IEC 60601-1 was published today.
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
This new Edition has many new requirements, including the necessity for Risk Management (ISO 14971)

The Collateral and Particular Standards are being updated to this new requirements and Clause numbering.


2003/06/27 - UL Releases UL 60601-1 (Replaces UL 2601-1)

UL released its newest edition of the harmonized IEC60601-1 standard: UL60601-1, Ed. 1 (Medical Electrical Equipment, Part 1: General Requirements for Safety), published April 25th, 2003. It "replaces" UL2601-1, Ed. 2.

NOTE: This new standard is an editorial format change only, and does not change ANY of the requirements.
UL60601-1 combines Amendment 1 and 2, as well as the US Deviations into the body of the standard (whereas the UL2601-1 Ed. 2 had the US Deviations in the front and the Amendments at the rear of the document).



2002/07/16 - MECA Founded

Medical Equipment Compliance Associates, LLC established by Brian Biersach

If you have suggestions for this website or information that you would like to see, please let us know at info@60601-1.com
Much of the information presented on this website came from questions and suggestions from our clients and visitors to this site.
We would love to hear from you!

Thank you,

Brian R. Biersach
President, Sr. Biomedical Engineer

MECA
Medical Equipment Compliance Associates, LLC

8350 S. Benjamin Dr.
Oak Creek, WI 53154
Email: bb@60601-1.com
Phone: 262-752-4017 x101
eFax: 847-919-3512