|
  
- Speed Your Medical Equipment to Market -
     
     
|
Thank you for visiting MECA's website for the information and
resources you need |
|
MECA Team: Jeremi Peck, Heidi Kramer, Paula
Biersach, Brian 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
Information covering medical Certification and Regulatory requirements
• 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?
• Speeding the process of obtaining your third party
safety marks (UL, CSA, etc.) and lowering your overall evaluation costs
• Marketing your medical device in the European
Union (CE Marking under the MDD - Medical Device Directive) and the
rest of the world
• See the Information
Page and Links Page for Certifications and
Employee Biographies
FREE Documents for Downloads:
• '601 Evaluation Package: Checklist for the Medical
standards UL/EN/IEC 60601 with requirements and national deviations,
• Test data sheets, Critical Component Guide, UL
Classification Markings, Device marking and user manual checklist,
and more
• See the Downloads Page
for Files Available for Download
MECA Services
• Medical Equipment Compliance Evaluation to
Reference Standard(s)
• Medical Equipment Testing to Reference Standard(s)
or Client's Specifications
- IEC 60601-1, UL 60601-1, EN 60601-1, CSA C22.2
No. 601.1, IEC 60601-1-X Collaterals, IEC 60601-2-XX Particular Standards
- Many ISO, IEC, EN, AAMI, and ANSI Medical Standards
• Partial and Total Compliance Outsourcing Services
• Compliance Engineering Services
• Training and Seminars on Medical Standards and
Compliance-Related Topics
• See the Services Page
for a List of Medical Equipment that MECA has Experience in Evaluating
MECA Experience and Expertise
• ISO 17025 and ISO 9000 compliant Quality System
• US Technical Experts for AAMI on IEC/ISO Working
Group Committees for International Medical Standards Writing
• See the About MECA
Page for Certifications and Employee Biographies
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.
See our SERVICES page for more on how
we can help your company save both time and money on your
Certification and Regulatory work. |
|
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.
- 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. While this requirement is not often enforced, it is
specified in OSHA Standards Part 1910, Subpart S-Electrical, Sec. 1910.399.
• NRTLs include UL, CSA, TUV,
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.
- To meet your full marketing potential, a third
party safety mark is essential. |
|
UPDATES: |
|
2008/11/17 - MECA is now a CB Testing Laboratory (ACTL) for the
Medical Category |
|
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 CB Reports, issued by UL.
|
|
2008/10/16 - CSA Has Extended the Recognition of IEC 60601-1,
Second Edition to June, 2012 |
|
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 2010, giving a two year phase-in time for them, which
is typical for standard revisions.
|
|
2008/07/16 - All MECA Phone Extensions Have Changed |
|
Our new voicemail system required us to change all of
our phone extension numbers.
Please see the CONTACT page
for our new extensions.
|
|
2008/04/02 - Effective Dates for the Third Edition of IEC 60601-1
(and National Standards based on it) |
|
The FDA presented that they will be recognizing IEC
60601-1:2005 this year (2008). This recognition will most
likely be done as a special update to their consensus standards
database after the spring update (spring update will be April/May,
2008). The FDA is currently considering a phase in period through
2010, however, this will be confirmed once the standard is
recognized. FDA will be recognizing the AAMI version (AAMI ES
60601-1:2005), which includes deviations from IEC 60601-1:2006 + C1:2006.
CSA has issued their version of the 3rd edition -
CAN/CSA C22.2 No. 60601-1-08. This standard will replace
CAN/CSA C22.2 No. 601.1M90. CAN/CSA C22.2 No. 60601-1-08 does
have deviations from IEC 60601-1:2006 + C1:2006. Currently
Health Canada has announced an effective date for compliance with the
third edition of December 15, 2008 (See update above).
The FDA and Health Canada have been discussing on collaborating an
effective date. This means that there is the potential that
Health Canada could change their effective date to match the FDA proposal.
For Europe, CENELEC has published EN 60601-1:2006
(based on IEC 60601-1, 3rd edition). The dop (date of publication)
was July 1, 2007. The dow (date of withdraw) for use of EN
60601-1:1990 (2nd edition), for devices not covered by a part 2, is
September 12, 2009. No dow is fixed for devices using part 2's
(particular standards). Although no dow has been established,
it's expected that it will be at most another 1 to 2 years before
each new collateral (IEC 60601-1-xx), and particular (IEC 60601-2-xx)
aligned with 3rd edition will have been published. Once a
medical device particular or collateral standard is published it
typically will have a 3 year transition.
The European Commission is responsible for issuing
updates to the Harmonized List of Standards, in the Official Journal.
When a new standard is listed, transition dates are included. To
date, EN 60601-1:2006 has NOT been added to the list of
harmonized standards.
|
|
2007/08/18 - Revised Test Data Package (Rev. 35) |
|
The IEC/UL/CSA/EN 60601-1 Data Package.doc Test Data Package
has been revised to Rev. 35. Please update your copy.
Get it FREE on our DOWNLOADS page
 |
|
2008/01/31 - MECA Clients |
|
We are honored to service 5 of the Top 10 Medical Manufacturers
Worldwide (14 of the Top 40) as clients
(per MD&DI -
December, 2007 Ranking)
|
|
2007/03/12 - Revised Documents for Download (Evaluation Package
Rev. 34) |
|
The MECA-60601Eval-Rev34.pdf Evaluation Package has been
revised to Rev. 34. Please update your copy.
The Revision includes an updated standards list and new Significant
Interpretations and compliance notes.
The 60601 Label-Manual Checklist (Rev 34).pdf Checklist has
been revised to Rev. 34. Please update your copy.
The 60601 Critical Components Checklist (Rev34).doc Table has
been revised to Rev. 34. Please update your copy.
The IEC-UL-CSA-EN 60601-1 Data Package.doc Test Data Package
has been revised. Please update your copy.
The 60601symbols.doc Symbols table has been revised.
Please update your copy.
The ULclassification.doc UL Marking guide has been
revised. Please update your copy.
Get them FREE on our DOWNLOADS page
     |
|
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.
|
|
2004/07/07 - UL 544 & UL 187 Extension |
|
UL announced that it will extend the withdraw
date of UL 544 and UL 187 to January 1, 2010 - WITH two very
important stipulations:
- There can be no product changes (changes that
would require revision of the UL Report - Follow-Up Service Procedure).
- The C-UL (Canadian coverage) for CSA C22.2 No.
125 will be dropped, so Medical and Dental products will no longer
have Canadian coverage.
Announcement Summary:
UL announces the modification of previously
established effective dates for the withdrawal of UL 187 and UL 544
UL’s August 5, 2002 bulletin indicated that
Standards UL 544 and UL 187 would be withdrawn when the IEC
harmonized Standard UL 60601-1 became effective. The withdrawal date
for UL 544 and UL 187 was projected to be January 1, 2005. However,
UL received significant input to consider postponing the withdrawal date.
UL now plans to postpone the withdrawal of Standards
UL 544 and UL 187 until January 1, 2010 to provide for a longer
transition period for products that are not frequently redesigned.
The effective date for all currently Listed products
to comply with UL 60601-1 will be January 1, 2010.
The postponement will allow for the continued
certification of products under UL 187 and UL 544, with one very
important proviso: that there can be no product changes (changes that
would require revision of the FUS Procedure) to currently certified
products subsequent to January 1, 2005.
Until January 1, 2005, a manufacturer will be able to
modify the existing product for compliance with UL 187 and UL 544
requirements when the changes are not substantial.
Due to the postponement for withdrawal, the following
categories will be maintained until 2010:
KFBQ – Medical and Dental Equipment, Professional
PAZB – Magnetic Resonance Imaging Equipment
ZQOR – X-Ray Equipment
ZQVQ – X-Ray Equipment, Accessories
CSA indicates that they will be implementing an
equivalent postponement for X-ray products that were evaluated to the
Canadian National Standard CSA 22.2 No. 114.
UL is working with CSA to maintain the parameters of
the postponement of the withdrawal of Standards equivalent; however,
CSA indicates they will not postpone the withdrawal of products that
were evaluated to the CSA 22.2 No. 125 standard (covering medical and
dental equipment).
As a result, UL cannot extend the C-UL Mark usage to
medical and dental products evaluated to CSA 22.2 No. 125 beyond
January 1, 2005.
Accordingly, all equipment previously manufactured and
certified to the requirements in the CSA C22.2 No. 125 standard must
comply with the requirements of the CSA C22.2 No. 601.1, Part 2
Series and Collateral Standards, as applicable, as of January 1, 2005.
Note: If CSA alters their position on any of the above
coverage dates, UL may find it necessary to make a corresponding
adjustment to the above certification withdrawal dates.
|
|
2004/01/05 - Article Published in IEEE Instrumentation &
Measurement Magazine |
|
IEEE Instrumentation & Measurement Magazine published "Regulatory
Requirements for Medical Equipment" co-written by MECA
founder Brian R. Biersach and based upon the material from our Information
Web Page.
(pdf download) |
|
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).
 |
|
2003/03/21 - Article Published in MD&DI |
|
Medical Device & Diagnostic Industry (MD&DI) published "Avoiding
Last Minute Design Changes to Meet Safety Requirements"
co-written by MECA founder Brian R. Biersach and based upon the
material from our Information Web Page.
(pdf download) |
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, Jeremi, Heidi, and Paula
 |