• SN EN 60601-2-41 : 2009 AMD 11 2011

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-41: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SURGICAL LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS

    Available format(s): 

    Superseded date:  19-11-2021

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Swiss Standards

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

    INTRODUCTION
    SECTION 1: GENERAL
    1 Scope and object
    2 Terminology and definitions
    4 General requirements for tests
    5 Classification
    6 Identification, marking and documents
    SECTION 2: ENVIRONMENTAL CONDITIONS
    SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
    14 Requirements related to classification
    16 ENCLOSURES and PROTECTIVE COVERS
    SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
    22 Moving parts
    24 Stability in NORMAL USE
    25 Expelled parts
    SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR
                EXCESSIVE RADIATION
    34 Ultraviolet radiation
    SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF
                FLAMMABLE ANAESTHETIC MIXTURES
    SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
                OTHER SAFETY HAZARDS
    42 Excessive temperatures
    44 Overflow, spillage, leakage, humidity, ingress of
          liquids, cleaning, sterilization and disinfection
    49 Interruption of power supply
    SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
                HAZARDOUS OUTPUT
    50 Accuracy of operating data
    SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;
                ENVIRONMENTAL TESTS
    52 Abnormal operation and fault conditions
    SECTION 10: CONSTRUCTIONAL REQUIREMENTS
    55 ENCLOSURES and covers
    56 Components and general assembly
    57 MAINS PARTS, components and layout
    59 Construction and layout
    Figure 101 - Example of power supplies for SURGICAL LUMINAIRES
    Figure 102 - STERILE HANDLE attachment and detachment tests
    Figure 103 - Test for ease of motion
    Figure 104 - Light distribution
    Figure 106 - Measurement of LIGHT FIELD DIAMETER and diameter
                 at 50% of CENTRAL ILLUMINANCE
    Figure 108 - Illuminance measurement with two masks
    Figure 109 - Illuminance measurement with four different
                 positions of the two masks
    Figure 111 - Detail of the inner surface of the tube (example)
    Figure 113 - Illuminance measurement at the bottom of a
                 cavity, with two masks
    Figure 114 - Illuminance measurement at the bottom of a
                 cavity, with four different positions of the
                 two masks
    Figure 115 - Measurement of DEPTH of ILLUMINATION
    Annex L - References - Publications mentioned in this standard
    Annex AA (informative) Guidance and rationale for particular
                           clauses and subclauses
    Annex ZA
    Annex ZB

    Abstract - (Show below) - (Hide below)

    The summary of the General Standard (IEC 60601-1) applies except as follows: Details the requirements to be applied to surgical luminaires and luminaires for diagnosis as defined in 2.101 and 2.105 (referred to as equipment). Does not apply to headlights; laparoscopes; endoscopes and their light sources; luminaires used dentistry, general purposes or luminaires of an emergency lighting. The main object is to establish particular requirements for the safety of surgical luminaires and luminaires for diagnosis.

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    Document Type Standard
    Publisher Swiss Standards
    Status Superseded
    Superseded By
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