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

MECA Help Site

Medical Equipment Compliance Associates, LLC

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Useful Resources



The following links are provided to assist you in finding what you need.


UL Certifications Directory - Search by Company, UL File #, CCN, Keyword

MECA Useful Links
Useful Links Graphics


Standards

 

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)



ISO 80601-2-XX Standards



EN 60601 and 80601 Standards Search Link


EN 80601 Standards Search Link (Some not covered by CENELEC)



European Commission List of Harmonised Medical Device Standards and Due Dates

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)



Purchasing Standards

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


IEC Web Store -  Purchase IEC standards
AAMI - Purchase AAMI standards
Comm2000 - UL standards Store

TechStreet - Purchase IEC, ISO, UL, AAMI, CSA, EN, etc. standards
IHS Engineering - Purchase IEC, ISO, UL, AAMI, CSA, EN, etc. standards

IEC Standards
ISO Standards
IEC Standards
CEN Standards
Official Journal
Medical Device Directive
CENELEC Standards


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 (bb@60601-1.com) at MECA or service@whaleteq.com 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.

ECG/EKG Testers
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 (bb@60601-1.com) at MECA or Peter Selvey (peter.selvey@medteq.jp) at Medteq with questions.

Tester for Electrosurgical accessories (hand pieces and cables).

Electrosurgical Testers
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.

 


Associates


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

 

Minnetronix







MethodSense, Inc. - Contact: Russ King at rking@methodsense.com

  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.

 

Method Sense



 


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.

Protocol Link




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

Regulatory Technology Services






PLEXUS

  Equipment conceptualization, design, commercialization, manufacturing, fulfillment, and sustaining services

Plexus






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

HUI









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

Eisner Safety Consultants


Agencies

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

TUV Rheinland - Certified Product Directory

Intertek - Intertek Home Page (for ETL Safety Mark)
Intertek - Certified Product Directory

CSA - Canadian Standards Association Home page

CSA - Product Certification Directory

FDA - Food and Drug Administration Home page

FDA  - FDA recognized consensus standards search

FDA - 60601 Series of Recognized Consensus Standard
FDA - 80601 Series of Recognized Consensus Standard
FDA - Guidance document search page

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

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Experts in the field of medical certification and regulatory compliance with a commitment to quality service
Founded  2002

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