Navigation Links
Two UL Battery Safety Standards Are now FDA Recognized Consensus Standards for Medical Devices
Date:7/22/2014

NORTHBROOK, Ill., July 22, 2014 /PRNewswire/ -- UL (Underwriters Laboratories), a global safety science leader, has announced that the U.S. Food and Drug Administration (FDA) has recognized two UL battery safety standards as consensus standards for medical devices incorporating lithium or nickel-based batteries. The two standards are UL 2054 - Standard for Household and Commercial Batteries, and UL 1642 - Standard for Lithium Batteries (Cells).

Consensus standards are standards recognized by the FDA for use in evaluating medical devices before they are approved for market entry. The FDA's Center for Devices and Radiological Health (CDRH) believes that conformance with recognized consensus standards can support a reasonable assurance of safety and/or effectiveness for many applicable aspects of medical devices. In the case of medical devices using batteries, manufacturers can now use the proof of compliance with UL 2054 and UL 1642 as evidence of a device's safety and effectiveness.

According to Ibrahim Jilani, Battery Manager for UL's Consumer Technology Division, consensus standards are also a means to streamline the premarket review process. "The use of these recognized standards will not only help medical device manufacturers reduce regulatory obstacles to enter the U.S. and international markets but also help them satisfy FDA premarket review requirements."

Although certification is voluntary, UL anticipates this announcement will likely be a sizeable regulatory driver going forward whereby medical device manufacturers will look to have UL 2054 Compliant Nickel Cell Type(s), UL 1642 Compliant Lithium Cell Type(s), and/or UL 2054 Compliant Battery Pack(s).

"UL has more than 30 years of experience in battery standard development, safety and performance testing, fostering innovation in the industry and boosting confidence in battery quality," said Jilani. "We believe both
'/>"/>

SOURCE UL
Copyright©2014 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Quest Announces Battery-Powered Mobile Wireless Surgical Video Display Solution
2. New analog front end extends battery life of portable ECG equipment
3. UKs Flagship Health & Safety Event Has Successful Inaugural Year in London
4. Neurocrine Announces 12-Week Safety Results From Initial Phase IIB Study Of VMAT2 Inhibitor NBI-98854
5. Novartis Pharmaceuticals Corporation stands behind medication adherence activities and reaffirms commitment to patient safety
6. ENTSafety.com announces the launch of the 2014 design of the ENTSafety System for tonsil, adenoid and other throat surgeries.
7. Global Radiation Detection, Monitoring & Safety Market Report 2013-2017
8. Integrated Safety and Efficacy Analysis of Phase 2 Clinical Trials of Pacritinib in Patients with Myelofibrosis and Low Platelet Counts Presented at ASH Annual Meeting
9. Consumer Watchdog Calls On Kaiser CEO To Disclose Substance Abuse & Patient Safety Problems At Health System Following High Profile Denials By Kaiser Doc
10. Initial Studies of Channel Medsystems Cryothermic Therapy Demonstrate Preliminary Safety and Tolerability; Results Presented at the 42nd AAGL Global Congress
11. Esco Launches Its New Series of Labculture(R) and Labculture(R) Reliant Class II Type A2 Biological Safety Cabinets
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/21/2014)... N.J. , Nov. 21, 2014  PTC Therapeutics, Inc. ... the 2014 Legend of Technology Award for Vision, Innovation, and ... Ph.D., Chief Executive Officer. This award recognizes an individual who ... New Jersey for several decades. ... Technology Award," stated Stuart Peltz , Ph.D., CEO of ...
(Date:11/21/2014)... and MELVILLE, N.Y. , Nov. 21, ... ), one of the world,s largest health care services ... ), the world,s largest provider of health care products ... practitioners, today announced that the companies have entered into ... most comprehensive service and product offerings to office-based medical ...
(Date:11/21/2014)... 20, 2014 /PRNewswire/-- CANTEL MEDICAL CORP. (NYSE: CMN ) ... Officer, will be presenting at the 26 th Annual ... in New York . The formal presentation ... ET. In addition, Mr. Krakauer and Jorgen B. Hansen ... meetings during the day. An audio webcast ...
Breaking Medicine Technology:PTC Therapeutics Announces CEO, Dr. Stuart Peltz Recipient of The New Jersey Technology Council's 2014 Legend of Technology Award 2PTC Therapeutics Announces CEO, Dr. Stuart Peltz Recipient of The New Jersey Technology Council's 2014 Legend of Technology Award 3Cardinal Health And Henry Schein Enter Into Long-Term Strategic Agreement To Serve Physician Offices 2Cardinal Health And Henry Schein Enter Into Long-Term Strategic Agreement To Serve Physician Offices 3Cardinal Health And Henry Schein Enter Into Long-Term Strategic Agreement To Serve Physician Offices 4Cardinal Health And Henry Schein Enter Into Long-Term Strategic Agreement To Serve Physician Offices 5
... Johnson & Johnson Pharmaceutical,Research & Development, ... demonstrate doripenem (DORIBAX(TM), doripenem for injection), a,carbapenem ... in vitro against certain,strains of Enterobacteriaceae, including ... Enterobacteriaceae is a large group of ...
... annual ICAAC/IDSA meeting in Washington, D.C., WASHINGTON, ... nail,fungus, NB-002, has demonstrated a new topical approach ... diffusing through the skin that,surrounds the entire nail ... The data represent a unique approach to ...
Cached Medicine Technology:New Data Show In Vitro Potency of Doripenem Against Resistant Bacteria 2New Data Show In Vitro Potency of Doripenem Against Resistant Bacteria 3New Data Show In Vitro Potency of Doripenem Against Resistant Bacteria 4New Data Show In Vitro Potency of Doripenem Against Resistant Bacteria 5NanoBio Demonstrates New Topical Approach to Treating Nail Fungus That Circumvents Problems with Current Therapy 2NanoBio Demonstrates New Topical Approach to Treating Nail Fungus That Circumvents Problems with Current Therapy 3
(Date:11/23/2014)... To show thanks to new and old customers, iFitDress.com ... dresses for weddings. Customers who need custom outfits can ... distinguished dress manufacturer, and it is among the ones which ... very long time. The CEO of this company says, "iFitDress.com ... to buy not only a beautiful dress, but also a ...
(Date:11/23/2014)... 2014 “BlackVue” was featured on NewsWatch ... which features the latest and coolest technology products available ... for NewsWatch, conducted the product review and shared with ... options in the car camera industry. , The need ... be hard to find the one that’s right per ...
(Date:11/23/2014)... City, Utah (PRWEB) November 23, 2014 ... health insurance reimbursement for small businesses, announced their ... book, The End of Employer-Provided Health Insurance. ... insurance is the greatest financial risk facing most ... facing U.S. employers, small and large, when it ...
(Date:11/22/2014)... Recently, UWDress.com, a successful wedding dress shop, ... attire in order to prepare for the wedding season. ... 70% off. , UWDress.com is a reliable company that ... especially the new items -- formal wedding guest attire. This ... market, including superstar and princess. As one of the leading ...
(Date:11/22/2014)... York, NY (PRWEB) November 22, 2014 ... Therapeutics Goods Administration (TGA) approved it for use ... was approved and listed within the Therapeutic Goods ... http://www.comlaw.gov.au/Details/F2014L01277 , Kyowa Hakko’s Setria® Glutathione will ... a biotech specialist that sources and imports fine ...
Breaking Medicine News(10 mins):Health News:iFitDress.com: Wonderful White Evening Dresses Now Available 2Health News:A Leader in Front and Rear Facing In-Car Cameras was Featured on NewsWatch Television on October 30, 2014 2Health News:Zane Benefits, Inc. Announces New Webinar on The End of Employer-Provided Health Insurance Now Available On-Demand! 2Health News:Formal Wedding Guest Attire Added to UWDress.com 2Health News:Setria® Glutathione Now Available in Australia 2Health News:Setria® Glutathione Now Available in Australia 3
... Grab your apron, roll up your sleeves, and get ready ... fun for the whole family when Lazarex Cancer Foundation hosts "Hogs ... 10:00 p.m at the Duplin County Events Center in Kenansville. , ... the recently launched North Carolina chapter of Lazarex Cancer Foundation and ...
... centered on motivational interviewing and cognitive behavioral skills training ... teen smokers, according to a pair of studies published ... National Cancer Institute . Arthur V. Peterson, ... in Seattle, and colleagues designed the Hutchinson Study of ...
... scientists report , MONDAY, Oct. 12 (HealthDay News) -- ... of mice by suppressing the activity of a gene ... life span of cells, and they say the finding ... in humans. , "A lifelong genetic modification of the ...
... ... its Medicare Choices program into three additional New York counties - Washington, Warren, and Essex ... to the CDPHP individual Medicare Choices PPO plans, effective January 1, 2010. , ... Albany, N.Y. (Vocus) October 12, 2009 ...
... Oct. 12 , -- The Health Information Technology ... step in the development of a national and interoperable healthcare ... -- Americans seek care from more than 600,000 physicians in ... of these physicians, however, cannot efficiently exchange patient information within ...
... Board is committed to educating and empowering Americans to embrace ... , which launched in 2008, is expanding. Designed ... delicious, wholesome recipes that are easy enough to be made ... include physical activity and exercise options to motivate people to ...
Cached Medicine News:Health News:'Hogs n Hens for Hope' NCPC BBQ Cook-Off & Festival October 17 at Duplin County Events Center Features Fun for the Whole Family and Benefits Lazarex Cancer Foundation 2Health News:Proactive, personalized telephone counseling can help teen smokers to quit 2Health News:A Gene Tweak Could Keep Heart Young 2Health News:A Gene Tweak Could Keep Heart Young 3Health News:CDPHP Medicare Choices Expands Service Area Northward 2Health News:CDPHP Medicare Choices Expands Service Area Northward 3Health News:Greenway Medical Technologies' EHR Platform Continues to Lead Interoperability Efforts With Participation in Key Health IT Integration Showcases 2Health News:Greenway Medical Technologies' EHR Platform Continues to Lead Interoperability Efforts With Participation in Key Health IT Integration Showcases 3Health News:Greenway Medical Technologies' EHR Platform Continues to Lead Interoperability Efforts With Participation in Key Health IT Integration Showcases 4Health News:California Walnuts' Popular Smart Menus Program Getting Smarter 2Health News:California Walnuts' Popular Smart Menus Program Getting Smarter 3
The Gizmo male external catheter is a latex catheter that uses a single-sided adhesive strip....
... The Mentor Freedom Pak Seven ... packaged week's supply of Freedom ... kit all 100% latex-free ... wipes for your convenience and ...
Clear Advantage® is a premium 100% latex-free, self-adhering, one-piece catheter designed for maximum wear. It features aloe in the adhesive, and a kink-resistant nozzle designed to eliminate blo...
... all-silicone non-adhesive male external catheter is ... latex-related allergic reactions. It is designed ... change external catheters several times a ... catheter comes with an adjustable strap ...
Medicine Products: