- Speed Your Medical Equipment to Market - USEFUL LINKS TO MEDICAL CERTIFICATION, REGULATORY, AND TEST EQUIPMENT SITES Please Email me if you find any broken links or have suggestions for relevant links info@60601-1.com UL Certifications Directory - Search by Company, UL File #, CCN, Keyword Standards: NOTE: Standards are copyrighted and not available in their published form for free. However, the UL 60601-1 Evaluation Package is available on the DOWNLOADS page of this site. It contains the requirements of UL60601-1, IEC60601-1, EN60601-1, CSA C22.2 No. 601.1, and the National Deviations in bullet-form, along with useful information and quick references for testing and spacing requirements.  This document is not a replacement for the standards, it is a tool to assist you in the design and evaluation of your medical electrical equipment.  It should be used with the standards, which can be purchased through the links below. IHS Engineering - Standards from many different agencies IEC Web Store -  IEC standards store IEC 60601-1, Collaterals, Particulars - Current IEC60601-x-xx standards & order TechStreet - Technical standards & information superstore TechStreet - UL 60601-1 order page TechStreet - IEC 60601-x-xx standards order page Comm2000 - UL standards on-line store Comm2000 - UL 60601-1 order page AAMI - AAMI Standards AAMI - ES 60601-1 order page Third Party Compliance Certification Agencies: UL - Underwriters Laboratories Home page UL - Product directory UL Standards - List of all UL standards CSA - International Home page CSA - Product directory TUV Rheinland - Medical Home page TUV Rheinland - Product directory OSHA - List of Nationally Recognized Testing Laboratories (NRTL) FDA: FDA - Food and Drug Administration Home page FDA  - FDA recognized consensus standards search FDA - Guidance document search page FDA - Device Advice FDA - Classify your medical device FDA - 510(k) Premarket Notification FDA - Good Manufacturing Practices (GMP) FDA - CDRH LASER Information FDA - LASER CDRH Report (21 CFR Sec. 1040.10  Laser products) FDA - Med Watch safety information & adverse event reporting FDA - Medical Device Reporting Search FDA - Download MDR Files FDA CDRH - Home page FDA CDRH - Medical Device EMC FDA - Human Factors Introduction - "Do it By Design" IEC: IEC - Home page IEC - On-line Catalogue Search CB Scheme: IEC - IECEE - Home page CB Scheme - Main page CB Scheme - Member countries CB Scheme - Test report forms CB Scheme - List of CB reports issued by all agencies AAMI:  AAMI - Association for the Advancement of Medical Instrumentation Home page AAMI - Standards AAMI - Committee Number IEC/SC 62D/WG 10  Medical Device Directive (MDD): Medical Device Directive - Complete wording New Approach - List of EU Directives New Approach - Harmonized standards for the MDD Other Agencies: CEN - CEN standards (non-electrical) FCC - Home page FCC - ID Search Form NIST - National Institute of Standards and Technology Home page NIST - National Center for Standards and Certification Information (NCSCI) National Fire Protection Association (NFPA)   Associates The following are associates that we work with and recommend: Minnetronix Inc. - Medical equipment design, development, manufacturing services Strategic Device Compliance Services - Mike Schmidt, Cincinnati, OH   A leader in medical device standards and regulatory compliance training and support.   Regulatory and Compliance training by experts involved in the creation of standards and regulations   Expertise in the design of efficient and effective design processes and procedures,   including Risk Management according to ISO 14971 O'Brien Compliance Management - Frank O'Brien, Lowell, MA Eisner Safety Consultants - Leo Eisner, Portland, OR HUI - Medical cart designer/manufacturer Information: 601 help - The medical device developer's guide to IEC 60601-1 Medical Electrical Equipment Information - Very useful resource for information Interpower - International power cord requirements for medical products FDA News - News & Information about the FDA The Safety Link - Links to International product safety news Manufacturers/Suppliers That Have UL Recognized Medical Grade Components : XP Power - Medical - Power supplies Toroid Corp - Medical grade isolation transformers in enclosures with plug/receptacles VICOR - DC-DC Converters Publications: Medical Devicelink - All publications by Medical Devicelink Medical Device & Diagnostic Industry (Publication) Conformity (Publication) Evaluation Engineering (Publication) Compliance Engineering - (Publication) Testing Equipment, Specific: QuadTech - Hipot, ground bond, LCR test equipment Fluke USA - DMMs WaveTek, MeterMan - DMMs Valhalla - Power Meters California Instruments - Testing power supplies (100-240 V, 50/60 Hz) Pacific Power Sources - Testing power supplies (100-240 V, 50/60 Hz) Elgar - Programmable AC sources Associated Research - HiPot & other equipment Dale Technology Inc. - Leakage current, grounding, patient simulators Seaword - Leakage current, grounding Compliance West - Hipot, ground bond testers Vitrek - Hipot, ground bond testers Keithley - Measurement equipment Biomedtronics Inc. - Dale, Ophir, Meterman, Fluke, Riken, Inovision distributor Testing Equipment, Parts, General: Newark Electronics - Parts and test equipment Allied Electronics - Parts and test equipment McMaster-Carr - Parts (UL Test Ball, etc.) Grainger - Tools, parts, & test equipment - good selection Davis Inotek - Equipment & calibration - good website Cole-Parmer - Laboratory test equipment ED&D Products - IEC 60601-1 test equipment   Global Test Supply - Test equipment purchase GlobalSpec - Test equipment, tools, parts. Great test equipment search feature General Atomics - Defib capacitors Techni-Tool - Test equipment and tools, god search results - thumbnails of parts Technika - Precision measurement instruments ValueTronics - New and reconditioned test equipment TestQuote - New & used test equipment, submit requests for free quotes Surplus Sales of Nebraska - Good misc. parts (high voltage wire, variacs, etc.) MetricTest - New, used, refurbished test equipment Time Motion Tools - Tools & test equipment - good prices Future Electronics - Parts & test equipment - good prices LabX - New & reconditioned lab & medical equipment TransCat - Equipment & Calibration Alpha Electronics - Test equipment Test Equity - New & used equipment, good prices Used-Line.com - Used test equipment Naptech - New & used test equipment CalTek Company - New & used test equipment, calibration WebTronics - Electronics parts & equipment - good selection Test-Equipment.net - Used test equipment - text website Advanced Test Equipment - Rental & used test equipment RenTelco - Rental & used test equipment Bell Electronics - Sales, rental, leasing of new and refurbished test equipment