Skip to content
Please enter a keyword to search
  • Preview

    I.S. EN 60601-1-10:2008&A1:2015&A2:2021

    Current The latest, up-to-date edition.
    Add to Watchlist
    This Standard has been added successfully to your Watchlist.
    Please visit My Watchlist to see all standards that you are watching.
    Please log in or to add this standard to your Watchlist.
    We could not add this standard to your Watchlist.
    Please retry or contact support for assistance.
    We could not add this standard to your Watchlist.
    Please retry or contact support for assistance.
    You have already added this standard to your Watchlist.
    Visit My Watchlist to view the full list.

    Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007/A2:2020)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  08-02-2021

    Publisher:  National Standards Authority of Ireland

    Add to Watchlist

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Add To Cart

    Table of Contents - (Show below) - (Hide below)

    FOREWORD
    INTRODUCTION
    1 Scope, object and related standards
    2 Normative references
    3 Terms and definitions
    4 * General requirements
    5 ME EQUIPMENT identification, marking and documents
    6 Accuracy of controls and instruments and protection against hazardous outputs
    7 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
    8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) development
    Annex A (informative) General guidance and rationale
    Annex B (informative) Description of dynamic performance of a PCLCS
    Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS
    Bibliography

    Abstract - (Show below) - (Hide below)

    This collateral standard specifies requirements for the development (analysis, design, VERIFICATION and VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) as part of a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) to control at least one PATIENT VARIABLE (i.e. a PHYSIOLOGIC VARIABLE) in ME EQUIPMENT and ME SYSTEMS.

    General Product Information - (Show below) - (Hide below)

    Committee ISO/TC 121/SC 3
    Document Type Standard
    Product Note The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective