• AAMI ID26:2004

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS

    Available format(s):  Hardcopy, PDF

    Superseded date:  06-04-2024

    Language(s):  English

    Published date:  01-01-2013

    Publisher:  Association for the Advancement of Medical Instrumentation

    Add To Cart

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

    Glossary of equivalent standards
    Committee representation
    Foreword
    Introduction
    AAMI deviations from IEC 60601-2-24:1998
    SECTION ONE - GENERAL
    1 Scope and object
    2 Terminology and definitions
    3 General requirements
    5 Classification
    6 Identification, marking, and documents
    SECTION TWO - ENVIRONMENTAL CONDITIONS
    10 Environmental conditions
    SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
    14 Requirements related to classification
    17 Separation
    19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
    SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
    21 Mechanical strength
    SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
                   EXCESSIVE RADIATION
    36 Electromagnetic compatibility
    SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
                  FLAMMABLE ANESTHETIC MIXTURES
    SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
                    AND OTHER SAFETY HAZARDS
    44 Overflow, spillage, leakage, humidity, ingress of liquids,
       cleaning, sterilization, disinfection, and compatibility
    47 Electrostatic charges
    49 Interruption of the power supply
    SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
                    AGAINST HAZARDOUS OUTPUT
    50 Accuracy of operating data
    51 Protection against hazardous output
    SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS:
                   ENVIRONMENTAL TESTS
    SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
    54 General
    56 Components and general assembly
    Appendix/Annex
    L - References - Publications mentioned in this standard
    AA - General guidance and rationale

    Abstract - (Show below) - (Hide below)

    Provides requirement for INFUSION PUMPS, INFUSION CONTROLLERS, SYRINGE PUMPS and PUMPS FOR AMBULATORY USE.

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

    Committee ID
    Document Type Standard
    Product Note Reconfirmed 2004
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
    IEC 61000-4-4 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST
    IEC 60521:1988 Class 0.5, 1 and 2 alternating-current watthour meters
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 61000-4-4:2012 RLV Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
    ISO 7886-2:1996 Sterile hypodermic syringes for single use Part 2: Syringes for use with power-driven syringe pumps
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    IEC 60801-1:1984 Electromagnetic compatibility for industrial-process measurement and control equipment. Part 1: General introduction
    IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
    IEC 60651:1979+AMD1:1993+AMD2:2000 CSV Sound level meters
    IEC 60801-2:1991 Electromagnetic compatibility for industrial-process measurement and control equipment - Part 2: Electrostatic discharge requirements
    IEC 60804:2000 Integrating-averaging sound level meters
    • 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