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

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

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

MECA is based in southeastern Wisconsin, and has assembled the top medical equipment compliance specialists in the field to provide full compliance services to our clients in a cost-effective manner.
MECA's services include the evaluation, testing, and compliance reports for medical devices, to meet FDA and MDD (CE Marking) requirements, as well as third party safety certification marks (NRTL Safety Marks). They also offer compliance services and training, to assist in the design and development of medical devices, to meet the international requirements.

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,
   - Critical Component Guide, 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
  • See the JOBS Page for positions currently available

UPDATES:

2010/09/01 - MECA Has Moved to Our New Facility

MECA has moved to our new location, 10 minutes from our previous location in Oak Creek.

Due to the expanding demand in the medical compliance field, it was decided to move to a larger facility.
This will provide us the needed room to expand to meet client's needs.

Our new facility includes a 1,500 sqr.ft. work shop, a 600 sqr.ft. lab, and 900 sqr.ft. of office space.
The new address is:
MECA
5060 W. Ashland Way
Franklin, WI 53132

2010/07/06 - Jim Wismar Has Joined MECA as Our New Senior Project Engineer

Jim joins us from Smiths Medical, and has 12+ yeas experience with medical equipment and compliance.
With Jim's help, we will be able to further reduce our evaluation times.

2010/06/11 - FDA Officially Recognizes 3rd Edition, and Specifies Transition Date

The FDA now officially recognizes IEC 60601-1, 3rd Edition in the Federal Register
For 510(k) and PMA submissions in the United States, they will continue to accept declarations of conformity to IEC 60601, 2nd Edition until June 30, 2013.
After this three year transitional period, declarations of conformity to IEC 60601-, Ed. 2 will not be accepted.
The Link to FDA's website with details: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?id=28193

Note that the US Deviations to IEC 60601-1, Ed. 3 are required in the US.
These deviations are in the AAMI ES 60601-1 standard (ANSI/AAMI ES60601-1:2005).
This AAMI standard includes original IEC text, plus U.S. differences/deviations.
See the AAMI news at: http://www.aami.org/news/2010/031210.press.60601.html

2010/04/03 - Revision 35 of Evaluation Package and Rev. 38 of the Test Data Package

The IEC, UL, CSA, EN 60601-1 Evaluation Package, Rev. 35 has been added.
This will be the last revision of the Evaluation Package for the 2nd Edition Harmonized standards.
Get the FREE documents and forms on the Downloads Page

The 3rd Edition Evaluation Package is nearing completion, and will be added as soon as it is done.

2010/03/15 - Transition to the 3rd Editon: EN 60601-1: 2006 DOCOPOCOSS (Date Of Cessation Of Presumption Of Conformity Of Superseded Standard)

INFORMATION FOR EUROPEAN TRANSITION TO THE 3RD EDITION (from CENELEC)

CENELEC/TC 62 has decided that, with the publication of EN 60601-1:2006, compliance with EN 60601-1:1990 and its related collateral standards will no longer give ‘presumption of conformity’ with the European directives covered as of 2012-06-01. This is the so called DOCOPOCOSS (Date Of Cessation Of Presumption Of Conformity Of Superseded Standard), which is published in the Official Journal of the European Union.

The CENELEC/TC 62 decision on the DOCOPOCOSS of 2012-06-01 was confirmed by the CENELEC Technical Board in October, 2009 (decision D135/C228). Publication in the Official Journal of the European Union (OJEU) is necessary for this decision to enter into force. This publication is expected in spring of 2010.

The part 2 standards referencing EN 60601-1:1990 will remain to give presumption of conformity with the directives until their own DOCOPOCOSS.

For those medical devices for which a part 2 exists (i.e., a standard labeled EN 60601-2-x or EN 80601-2-x), the transition period for that part 2 is decisive.
One must consider that a part 2 is essentially the content of the main document (EN 60601-1), together with the content of all the relevant collateral standards (all EN 60601-1-x), and then modified by the content of the part 2. If the transition period of the part 2 ends, for example, on 21 November 2011 then, after this date, compliance with the old (‘superseded’) standard no longer gives the presumption of conformity with the Essential Requirements covered by the standard. In this situation, the 2012-06-01 date is not relevant for that device.

For products for which there is no (harmonized) part 2, compliance with the main standard and related collaterals can be used to claim presumption of conformity. The DOCOPOCOSS date of 2012-06-01 implies that, after that date, compliance with EN 60601-1:1990 will no more give that presumption of conformity. Until that date, since both EN 60601-1:1990 and EN 60601-1:2006 are listed in the OJEU, either standard (with its set of collaterals, etc.) can be used to claim presumption of conformity.

It is not possible to use the EN 60601-1:2006 with the old collateral standards.
Since the main standard was substantially modified in its revision to the 2006 version, the collateral standards had to be modified as well. As a result, it is not possible to mix standards from different “era”. You are encouraged to check the normative reference clause of the collateral standards to find out which edition of the general standard is related to that edition.

NOTES:

There are several collateral standards that relate to EN 60601-1:1990, for which the same DOCOPOCOSS applies as it does for EN 60601-1:1990.
These are: EN 60601-1-2:2001, EN 60601-1-3:1994, EN 60601-1-6:2004, and EN 60601-1-8:2004 (all with their respective amendments).
There are two more collateral standards that relate to EN 60601-1:1990; these are EN 60601-1-1:2001 and EN 60601-1-4: 1996 (with A1:1999).
The relevant parts of these two collateral standards were revised and updated, and included in EN 60601-1:2006.
As a consequence, the DOCOPOCOSS for these two collaterals will be connected with the DOCOPOCOSS of the EN 60601-1:2006.

Not all EN 60601-standards adopted by CENELEC/TC 62 as EN’s have been developed by IEC exclusively. Some standards in this framework are the result of a joint effort between ISO and IEC, which is made more visible by replacing the first digit in the 60601-numbering into an “8” (IEC/EN 80601 Standards).

The text in the foreword of EN 60601-1 says “However, when Part 1 is used for appliances not covered by a part 2, EN 60601-1:1990 is not to be used after 2009-09-12".
This was included to stimulate manufacturers to consider using the latest edition. In itself, that text does not constitute any legal obligation or a change in the right to claim presumption of conformity. The legal situation is that as long as EN 60601-1:1990 and its amendments have a current listing in the Official Journal of the EU, they will continue to provide presumption of conformity with the Essential Requirements of the MDD covered by the standard. In spite of their listing in the OJ, harmonized standards remain voluntary, so there is never a legal obligation to use them.

SUMMARY:

All existing medical equipment being sold in Europe must be evaluated/re-evaluated to the Third Edition of EN 60601-1 (2006), EXCEPT where there is an applicable Particular Standard (EN 60601-2-xx), where the date of withdrawl (DOCOPOCOSS) of that Particular Standard would be the required date to have the medical equipment evaluated/re-evaluated to the Third Edition of EN 60601-1 (2006), with the Particular(s)

This will be EXTREMELY difficult to meet for every medical device on the market in Europe, as the certification agencies are backlogged already.
It is difficult to anticipate what will happen when the 2012-06-01 date arrives, and all of the certification agencies are backlogged by 6 Months or longer.
Will there be another extension if companies are backlogged getting through the certification agencies?
No one knows, but I wouldn't bank on it.

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 for 3rd Edition) to apply the UL Classification Mark.
Please be sure that none of your devices are still having the UL Listed Mark applied.

OLDER RELEVANT INFORMATION:

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

2009/06/22 - 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.

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

MECA (Medical Equipment Compliance Associates, LLC) founded 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,

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