• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    The Producto Group Appoints Mark C. Rauenzahn as Chief Executive Officer

    Coloplast Launches New Catheter in the U.S.

    Josh Ghaim and Sachin Jain Join Cue Health Board of Directors

    NAMSA Relaunches Medtech Outsourcing Solution

    Rollomatic Inc. Welcomes Joe Kane as CEO
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Reflections on 2022 and What’s Ahead for Medtech: MPO Sounding Board

    3 Ways to Prepare for ISO 13485/Part 820 Harmonization

    A New Home for Theranos' Elizabeth Holmes?

    Health Cost Drivers for Large Employers

    Braving Change: Facing Fears in the Midst of Major Transitions
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Halkey-Roberts Corporation

    Paragon Medical

    Medbio LLC

    LEMO USA Inc.

    Fusion Biotec Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Artificial Intelligence Can Combat Key Issues Impacting Healthcare

    Why Advanced Sensors Are Crucial Within Medical Pumps

    How Artificial Intelligence Could Help Prevent 80% of Chronic Diseases

    4 Ways to Use Injection Molding in Medical Device Manufacturing

    Telemedicine and Connectivity to Drive Material Innovation in the Near Future
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Halkey-Roberts Corporation

    Paragon Medical

    Medbio LLC

    LEMO USA Inc.

    Fusion Biotec Inc.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Columns

    Home Healthcare: How the IEC 60601-1-11 Standard Impacts Power Safety Requirements

    Additional measures must be taken to ensure equipment remains safe for use in the home environment.

    Home Healthcare: How the IEC 60601-1-11 Standard Impacts Power Safety Requirements
    Dylan Howes, Applications Engineer, TT Electronics01.29.20
    With the growth of an aging population and the rising cost of hospital-based care, advanced technologies are being developed to facilitate remote healthcare. Moving healthcare out of the hospital and into the home offers patients, healthcare providers, and insurers both convenience and cost savings. A challenge arises, however, for regulatory authorities (and OEMs) in determining appropriate safety considerations for these technologies. Unlike hospitals, patients’ homes are uncontrolled environments. There are no trained equipment operators or guarantee of a proper electrical installation.

    Accordingly, additional measures must be taken to ensure equipment remains safe for use in these environments. To standardize these additional measures, a group of clinicians, engineers, and regulators established the 60601-1-11 collateral requirements for medical electrical equipment and systems used in the home healthcare environment.

    Provisions of the standard impose several constraints on the selection of AC/DC power converters for home healthcare applications. As OEMs endeavor to bring equipment originally designed for use in a clinical environment to the home, they often learn a single converter will not suffice for both environments. It’s important to understand how requirements of the collateral standard impact the selection of an AC/DC power converter for the home and what constraints to consider when using a 60601-1 general standard certified converter.

    Low-Line Operation to 85 Percent of Nominal
    The 60601-1 general standard assumes supply mains are expected to have a 10 percent tolerance from nominal. That is, if a device is to be rated for operation on supply mains ranging from 100 to 240 VAC (Universal Line), the device must safely function on input voltages ranging from 90 to 264 VAC. Mains voltages in the home may be less predictable. For this reason, the 60601-1-11 collateral standard assumes nominal mains voltages may exhibit a tolerance of +10 percent/-15 percent, corresponding to an operational input voltage range of 85 to 264 VAC for universal line input devices.

    The first impact the lower-line operation requirement has on the power converter is the presence of greater primary-side currents. A converter’s input current can be modeled as a function of output power, efficiency, power factor, and line-voltage:


    Where Pout is the output power in Watts, pf is the power factor, and η is the conversion efficiency. If one assumes efficiency and power factor are both independent of line voltage (which is generally not true but simplifies this discussion without muddying the implications) then, for a given load, the input current is inversely proportional to the line voltage.

    Accordingly, a 5.55 percent reduction in line voltage (90 VAC down to 85 VAC) results in roughly a 5.9 percent increase in line current. The key observation is that any current margin or thermal (I2R) margin designed into the primary side components has been significantly reduced if the converter was designed for a minimum line voltage of 90 VAC.

    Increased primary side currents are not the only concern. Typically, the input voltage is directly related to the amount of energy per cycle the converter is physically able to transfer to secondary. A reduction in input voltage (while made up by current hikes from a power perspective) can ultimately reduce the amount of energy that can be transferred per cycle. When the input voltage is reduced below the anticipated minimum, there is a risk of maxing out the switching frequency and/or duty cycle. In such a case, the converter will be rendered unable to sustain its rated load.

    The solution for a 60601-1 general standard certified power supply unit (PSU; designed for 90-264 VAC operation) is output power derating. It is trivial to calculate the output power reduction required to offset the increases in primary side currents according to the aforementioned formula, but a bit more difficult to anticipate effects on the actual conversion process. Inquire with the PSU manufacturer regarding an appropriate low-line derating strategy.

    Class II Construction
    Power converters must provide users with at least two means of protection from hazardous voltages. Class I power supplies protect users via a single layer of basic insulation and a protective Earth ground connection, which keeps users safe by providing a low impedance path to zero potential for fault currents to follow. The PSU manufacturer’s ability to ensure that path has an appropriately low impedance ends at the PSU AC inlet. Earth ground connections in older homes are notoriously unreliable (if existent) and can be easily bypassed by users. IEC 60601-1-11 does not allow OEMs to rely on in-home Earth ground connections for one of the two required protection mechanisms. Rather, the collateral standard requires power supplies be of construction Class II.

    Class II power supplies utilize additional basic insulation or reinforced insulation to ensure that with or without a reliable Earth ground connection, users are properly protected from hazardous voltages.

    BF Class Output
    Clause 6 of the collateral standard mandates if the medical electrical equipment is equipped with applied parts, those parts must be type BF at minimum. While a BF ready power supply is not necessarily required to facilitate the use of type BF applied parts, it can make the process simpler. It is important to recognize power supplies themselves are not applied parts and, therefore, do not have an applied part type directly associated with them. However, the PSU can be selected to provide the required degree of isolation from ground and to properly mitigate leakage currents. Patient auxiliary currents must be constrained to 100 µAac (500 µAac under single fault conditions) and not all 60601-1 certified power supplies offer BF class outputs.

    As was detailed in the previous section, power supplies for home healthcare applications must be of construction Class II, so the Earth ground isolation component of this characterization is moot. Patient auxiliary currents, on the other hand, must be constrained to 100 µAac (500 µAac under single fault conditions). Not all 60601-1 certified power supplies offer BF class outputs.

    IP21 Rated Ingress Protection
    Per 60601-1-11, external power adaptors must be encased in a manner that provides at least IP21 rated ingress protection in accordance with IEC 60529, and must be labeled accordingly. One would be hard pressed to find a power adaptor that was not inherently solid ingress Level 2 (IP2x) compliant. The same is not true for IPx1, Level 1 liquid ingress protection.

    While the IEC 60529 test for IPx1, stipulating a drip rate of 1 mm/min (like a light rainfall) is seemingly benign, over the 10-minute test duration one may be surprised to find water dripping off the edges of a power supply enclosure can pool up at interfaces with cable strain reliefs, or along the edges of a removable AC blade attachment, and make its way into the electronics. This would constitute a failure and an inadequacy for use in a home healthcare application. Achieving IPx1 is not a difficult engineering problem to solve, and many off-the-shelf 60601-1 power supplies are inherently compliant, but one should be careful not to assume compliance.

    Augmented Mechanical Strength
    Medical electrical equipment used in an uncontrolled home environment is more likely to be subjected to mechanical disturbances than equipment used in a clinical environment. Playing children or rogue pets may inadvertently knock a device from a tabletop. A weekend away from home may require transport of home healthcare equipment in the trunk of a car traveling over speed bumps and rumble strips. There is a clear need for the equipment to remain safe and functional in the face of augmented mechanical stress.

    Basic safety and essential performance of a home healthcare power supply must be maintained after undergoing the following shock and broadband random vibration tests:

    Shock: Tested against IEC 60068-2-27:2008 with three half-sine pulses of 150 m/s2 peak acceleration and 11 ms duration through each axis.

    Vibration: Tested against IEC 60068-2-64:2008 for 30 minutes per each perpendicular axis with the following acceleration amplitude:

    10 Hz to 100 Hz: 1.0

    200 Hz to 200 Hz: -3db per octave

    200 Hz to 2,000 Hz: 0.5

    This is another example of a 60601-1-11 item that may very well be inherent to several well-designed general standard certified PSUs, but inherent compliance should not be assumed.

    60601-1-2 Edition 4—Electromagnetic Compatibility
    Power supplies for use in home healthcare applications must be compliant with IEC 60601-1-2 Edition 4. In addition to some nuanced deviations in emissions mandates over Edition 3, Edition 4 imposes some stringent immunity requirements including ESD contact discharge immunity of ±8 kV; ESD air discharge immunity of ±15 kV; radiated immunity for fields of strength up to 10 V/m and across a broader frequency range (80 Mhz to 2.7 GHz); mandated 100 kHz repetition rate for electric fast transients; test levels unchanged; tenfold increase in power frequency magnetic field immunity to 30 A/m; single cycle, 100 percent reduction voltage interruption test.

    Your Next Design
    When bringing your device to the home healthcare market, IEC 60601-1-11 imposes an additional 13 clauses over the 60601-1 general standard. A number of these design challenges are directly associated with careful selection of an appropriate power converter. By selecting a partner that is well versed in the nuances of the IEC 60601-1-11 standard as they pertain to power system requirements, your team can tap into expertise that will guide you well in your home healthcare power supply selection. 


    Dylan Howes, applications engineer at TT Electronics, manages all technical aspects of power converter design-in efforts, and authors technical content featuring power conversion trends and technologies. Connect with him at Dylan.Howes@ttelectronics.com.
    Related Searches
    • protection
    • test
    • compliance
    • medical
    Related Knowledge Center
    • Electronics
      Loading, Please Wait..

      Trending
      • The Future Of Biomedical Engineering Advancements
      • Cirtec Medical Corporation Acquires Precision Components Business From QMD
      • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
      • A New Approach To Post-Market Surveillance
      • The Producto Group Appoints Mark C. Rauenzahn As Chief Executive Officer
      Breaking News
      • The Producto Group Appoints Mark C. Rauenzahn as Chief Executive Officer
      • Coloplast Launches New Catheter in the U.S.
      • Josh Ghaim and Sachin Jain Join Cue Health Board of Directors
      • NAMSA Relaunches Medtech Outsourcing Solution
      • Rollomatic Inc. Welcomes Joe Kane as CEO
      View Breaking News >
      CURRENT ISSUE

      November 2022

      • MPO's 2022 Year in Review
      • Fine Print: A Discourse on Additive Manufacturing
      • Grab and Go: Examining the Thrombectomy Device Market
      • View More >

      Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
      You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

      • About Us
      • Privacy Policy
      • Terms And Conditions
      • Contact Us

      follow us

      Subscribe
      Nutraceuticals World

      Latest Breaking News From Nutraceuticals World

      BAPP Paper Reviews Common Adulteration Practices Which Go Undetected
      CRN Announces Promotions and Welcomes New Staff Member
      Quercetin Ingredient Linked to Improved COVID-19 Recovery: Study
      Coatings World

      Latest Breaking News From Coatings World

      PPG Achieves ISO 14001 Certification of Environmental Management System
      AmCoat’s Rhino Shield and Floor Shield Break Records in 2022
      Automotive Industry Leaders Form Cofinity-X JV
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      The Producto Group Appoints Mark C. Rauenzahn as Chief Executive Officer
      Coloplast Launches New Catheter in the U.S.
      Josh Ghaim and Sachin Jain Join Cue Health Board of Directors
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Jones Healthcare Group Installs BOBST NOVACUT 106 ER Flatbed Die-Cutter
      Pfizer Revenues Soar to Record-Breaking $100B in 2022
      iuvo BioScience Appoints Industry Exec to Lead Lab Biz
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      La Roche-Posay Named the Fastest Growing Skincare Brand of 2022 by NielsenIQ
      Disney Collaborates with Nailtopia on Limited-Edition Nail Collection
      Knoll Wins PCD Innovation Award for MAC Advent Calendar
      Happi

      Latest Breaking News From Happi

      Color Street Launches ‘Through the Cosmos’ Collection
      Curl Care Collection is New at Native
      Color Street Pledges $100K To Support Military & Veteran Appreciation
      Ink World

      Latest Breaking News From Ink World

      International Paper Reports Full-Year, 4Q 2022 Results
      UFlex Exhibits Sustainable Printing, Packaging Solutions at Plast India 2023
      Early-Bird Registration Opens for Print UV 2023
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      SABIC announces value chain partnerships
      Digital Embellishment Alliance launches new website community
      FLAG achieves record membership in 2022
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Superior Felt & Filtration Adds Domestic Injection Molding to its Medical Filtration Capabilities
      Ahlstrom Launches New Generation FluoroFree Technology
      Berry to Begin Production at India Healthcare Hub Early This Year
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Mobi-C Cervical Disc Replacement Procedures Top 200,000
      OPUM, Corflex Global Partner on Knee Assessment Technology
      ODT's Most-Read Stories This Week—Jan. 28
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Johan Hjertonsson Proposed as New Chairman of ASSA ABLOY
      Durak Highlights SilverPro Conductive Threads
      Arkema Partners with Research Institute to Open Lab in Mulhouse, France

      Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

      AD BLOCKER DETECTED

      Our website is made possible by displaying online advertisements to our visitors.
      Please consider supporting us by disabling your ad blocker.


      FREE SUBSCRIPTION Already a subscriber? Login