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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
(for 2nd Edition) is available
on the DOWNLOADS page of this site.
The 3rd Edition Package is being completed now.
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.
'60601 and '80601 Medical Standards List, including
those harmonized to the 3rd Edition of IEC 60601-1:
IEC
60601-1-XX, -2-XX Standards
IEC
80601-2-XX Standards
ISO
80601-2-XX Standards
All three above links must be used to find all the
applicable required '60601 and '80601 Standards (Base, Collaterals,
and Particulars).
Be sure to check the "Standards under
development" box in the ISO Standards list to get the standards
not yet published.
Purchasing Standards:
IHS Engineering
- Standards from many different agencies
IEC
Web Store - IEC standards store
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
NRTL
Certification Agencies:
OSHA
- List of Nationally Recognized Testing Laboratories (NRTL)
UL
- Underwriters Laboratories Home page
UL
- Product directory
UL Standards
- List of all UL standards
TUV
Rheinland - Medical Home page
TUV
Rheinland -
Product directory
CSA
- International Home page
CSA
- Product directory
FDA:
FDA
- Food and Drug Administration Home page
FDA
- FDA recognized consensus standards search
FDA
- IEC 60601-1 Recognized Consensus Standard
FDA
- Guidance document search page
FDA
- Device Advice - 510(k) and Premarket Approval (PMA)
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
IEC:
IEC - Home page
IEC
- On-line Catalogue Search
Standards Writing Committees:
IEC
Working Group 62 - TC/SCs - 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
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
CB
Scheme - MECA Scope
AAMI: 
AAMI
- Association for the Advancement of Medical Instrumentation Home page
AAMI
- Standards
Medical Device Directive (MDD):
Medical
Device Directive - Complete wording
MDD
- PDF format
New
Approach - List of EU Directives
Other Agencies:
CEN
- CEN standards (non-electrical)
FCC - Home page
FCC
- ID Search Form
NIST - National
Institute of Standards and Technology Home page
NFPA
- National Fire Protection Association
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ASSOCIATES
The following are associates that we continually
work with and recommend for their high quality services:
Minnetronix
Inc. -
Contact: Dirk Smith (Saint Paul, MN)
Medical equipment design, development, manufacturing services
Strategic
Device Compliance Services -
Contact: Mike Schmidt (Cincinnati, OH)
A leader in medical device standards and
regulatory compliance training and support/consulting.
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
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 management, software validation,
and business operations efficiency strategies for life science companies.
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
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
O'Brien
Compliance Management -
Contact: Frank O'Brien (Lowell, MA)
Compliance services, similar to MECA,
Training and seminars for medical
standards and compliance
Global EMC Inc.
- Contact: Ashwani Malhotra (Toronto, Canada)
An independent lab that offers a complete range
of Electromagnetic Compliance (EMC) testing
- Including RF, Wireless, Product Safety,
Environmental and Laser testing.
A true one stop compliance services to meet the
most demanding engineering issues.
Professional Engineers and experienced Technicians
- expertise in hardware design, filtering
applications, signal analysis, standards interpretation, and data acquisition.
Each EMC project has a designated lead EMC engineer
- ensures project success, from the initial
client planning and set-up to final report delivery.
Service both product safety and EMC clients
from a modern, 10,000 sq. ft. testing facility in Richmond Hill
- in the centre of Greater Toronto's high tech community.
An A2LA accredited lab under ISO 17025-1.
Their services are effective, timely and knowledgeable.
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
Manufacturers/Suppliers That Have
UL Recognized Medical Grade
Components :
Interpower
- International power cord requirements for medical products
XP Power - Medical
- Power supplies (UL)
Toroid Corp -
Medical isolation transformers in enclosures with
plug/receptacles (UL)
Tripp-Lite
- Medical isolation transformers in enclosures with
plug/receptacles (UL, ETL, TUV)
Plitron
- Medical isolation transformers in enclosures with
plug/receptacles (only CSA)
VICOR - DC-DC
Converters (UL)
Publications:
Medical
Device & Diagnostic Industry (Publication)
Medical
Devicelink - All publications by Medical Devicelink
Conformity (Publication)
Evaluation
Engineering (Publication)
Compliance Engineering
- (Publication)
Testing Equipment, Specific:
Associated Research
- Hipot & other equipment
QuadTech -
Hipot, ground bond, LCR test equipment
Fluke USA - Meters,
Fluke Biomedical
Valhalla
- Power Meters
Ametek (California
Instruments, Elgar) - Testing power supplies (100-240 V, 50/60 Hz)
Pacific Power Sources
- Testing power supplies (100-240 V, 50/60 Hz)
Seaword -
Leakage current, grounding
Compliance West
- Defib Simulators, Hipot, ground bond testers
Vitrek - Hipot,
ground bond testers
Biomedtronics Inc.
- Dale, Ophir, Meterman, Fluke 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
Sper Scientific
- Budget Precision measurement instruments
Global Test Supply
- Test equipment purchase
General Atomics
- Defib capacitors
Techni-Tool -
Test equipment and tools, god search results - thumbnails of parts
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
WebTronics
- Electronics parts & equipment - good selection
Test-Equipment.net
- Used test equipment - text website
Advanced Test Equipment
- Rental & used test equipment
Bell Electronics
- Sales, rental, leasing of new and refurbished test equipment
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