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For answers to your questions
Medical Equipment Compliance,
Certification, and Regulatory Services and Information
MECA Help Site
Medical Equipment Compliance Associates, LLC
Current IEC, ISO, and EN Standards List, With Dates
IEC 60601-1-XX, -2-XX Standards (Note - at times, the IEC website can take up to several minutes to load)
IEC/ISO 80601-2-XX Standards (Note - at times, the IEC website can take up to several minutes to load)
This is the NEW OJ (Official Journal) site (Scroll just over half way down to the EN 60601-1 standards)
Medical Device Directive (MDD)
(MDD 93/42/EEC for CE marking - pdf document download)
NOTE: Standards are copyrighted and not available in their published form for free
We suggest searching each source below for the best price on the standards you need
Test Equipment For Medical Devices
The following is test equipment that we use in our lab, and we have found to work exceptionally well.
whaleteq.com - Contact Brian Biersach (email@example.com) at MECA or firstname.lastname@example.org at WhaleTeq with questions.
Test and measurement equipment for medical equipment, primarily ECG and Electrosurgical Test and verification.
We use this test equipment in our lab for testing medical equipment for internationally accredited reports.
There is nothing we've found on the market that does what these ECG and Electrosurgical testers do.
If you are developing ECG equipment or ECG monitors, these are must have testers.
This covers the testing and verification for IEC 60601-2-25, -2-27, -2-47; AAMI/ANSI EC11, EC13, EC38, EC57; China YY1079, YY1139, YY0782, YY0885, within one system.
See the link above for a table, showing all the standard clauses covered using these testers.
Neutral Electrodes Impedance Tester
The HFPA150 is a unique tester designed for testing the neutral electrode (NE) impedance in electrosurgical systems.
Capable of generating signals with frequency ranging from 50 kHz to 5 MHz, producing current over 200 mArms, and sine wave with THD < 0.3%. The HFPA150 is designed for high stability output with adjustable frequency and gain functions. In addition to neutral electrode test, it could also be used as a measurement tool for general purpose generator where the specifications are appropriate.
MEDTEQ - Contact Brian Biersach (email@example.com) at MECA or Peter Selvey (firstname.lastname@example.org) at Medteq with questions.
Tester for Electrosurgical accessories (hand pieces and cables).
The HFIT tester is used for generating the high voltage, high frequency output needed to test electrosurgical accessories.
The required voltage and current needed for the testing in IEC 60601-2-2 is provided by this tester.
Using step-up transformers on an ESU to get these voltages does not work well, since the available current using this method is usually not enough to identify a failure (false pass).
If you are developing electrosurgical accessories, the HFIT tester is a tool you need.
The following are associates that we have a long experience working with, and recommend for their high quality services:
Minnetronix Inc. - Contact: Dirk Smith (Saint Paul, MN)
Medical equipment design, development, manufacturing services
Equipment conceptualization, design, commercialization, manufacturing, fulfilment, and sustaining services
Risk assessment and Risk Management solutions/.consulting for Life Science Companies.
Expertise includes IEC 60601-1, ISO 14971, ISO 13485, MDD 93/42/EEC, 21 CFR Part 820, AS/NZS ISO 31000, Annex 11,
21 CFR Part 11, and other regulations and standards.
Expertise also includes FDA submission support, quality assurance management system development, medical device technology
and software compliance, software validation, and business operations efficiency strategies for life science companies.
PROTOCOL LINK - Contact: Laura Spiegelhoff or Steve Weltler at (847) 549-0390 for discussion
Global project management firm who provides comprehensive consulting services for FDA-regulated companies.
Since 1996, completed over 750 projects to companies who follow cGMPs, in device, drug, and combination product categories.
Supports ISO 13485 and ISO 14971 requirements for UL and IEC 60601 registration; compliance management;
regulatory affairs submissions and technical writing including 510(k)’s; process, product, and systems validation.
Regulatory Technology Services LLC - Contact: Mark Job (Buffalo, MN)
Accredited by the FDA to perform third-party reviews of FDA 510(k) submissions
More than 300 submissions averaging approximately 30 days from receipt of the submission
to receipt of the Substantial Equivalence letter from the FDA
Equipment conceptualization, design, commercialization, manufacturing, fulfillment, and sustaining services
HUI - Contact: Julie Cosich or Mark Collins (Kiel, WI)
Quality Medical cart designer/manufacturer with IEC/UL/CSA/EN 60601-1, 2nd and 3rd Edition compliance experience
Eisner Safety Consultants - Contact: Leo Eisner (Portland, OR)
Prepare 510(k)s, Assist with PMA & IDE submissions,
Assist with preparation and assessment of Technical Files and Design Dossiers,
Assist in preparation of EU and/or CMDR Essential Requirement checklists, and Risk Analysis (ISO 14971),
Assist in the preparation of Clinical Literature Evaluations,
Evaluation of Clinical Data per MEDDEV 2.7.1, Review of product literature/packaging/labeling,
Audit your company to ISO 9000:2000, ISO 13485:2003, QSR, MDD (EU CE Mark) and CMDR
OSHA - Occupationa Safety and Health Administration list of Nationally Recognized Testing Laboratories (NRTL)
UL - Underwriters Laboratories Home page
UL Online Certification Directory - Look up UL Recognized, UL Classified, UL Certified, and UL Listed equipment and components
TUV Rheinland - TUV Rheinland Medical Home page
CSA - Canadian Standards Association Home page
CSA - Product Certification Directory
FDA - Food and Drug Administration Home page
FDA - FDA recognized consensus standards search
IEC - International Electrotechnical Commission Home page
IEC Working Group TC 62 - Electrical equipment in medical practice
IEC Working Group 62A - General standard writing committees
IEC Working Group 62B - Imaging standards writing committees
IEC Working Group 62C - Nuclear/Radiation standards writing committees
*IEC Working Group 62D - Particular standards writing committees
IECEE - International Electrotechnical Commission for Electrical Equipment Home page
IECEE CB Scheme - List of IECEE CB Scheme Members
IECEE CB Scheme - MECA CB Scheme CBTL member information and scope
AAMI - Association for the Advancement of Medical Instrumentation (Home page)
AAMI - Standards
MDD - Medical Device Directive (European Union Law) PDF format
New Approach - European Union List of Directives
CENELEC - European Cenelec standards (electrical)
CEN - European Cen standards (non-electrical)
FCC - US Federal Communications Commission
NIST - US National Institute of Standards and Technology
NFPA - US National Fire Protection Association