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About This Item

 

Full Description

1.1 Scope

Addition: This Particular Standard applies to X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES. Its scope excludes, in particular: - equipment for RADIOTHERAPY; - equipment for COMPUTED TOMOGRAPHY; - ACCESSORIES intended to be introduced into the PATIENT; - mammographic X-RAY EQUIPMENT.

NOTE 1 Examples of prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of EQUIPMENT complying with this standard is recommended, are given in annex BB.

NOTE 2 The particular requirements of this standard are not essential for EQUIPMENT used in all RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES. Examples of procedures, for which the use of EQUIPMENT complying with this standard is considered not to be essential, are given in annex BB. EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this standard.

 

Document History

  1. CAN/CSA C22.2 NO. 60601-2-43:24


    Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (Adopted IEC 60601-2-43:2022, third edition, 2022-12, with Canadian deviations)

    • Most Recent
  2. CAN/CSA C22.2 NO. 60601-2-43:11+A1:19+A2:21(R2021)


    Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (IEC 60601-2-43:2010+A1:2017+A2:2019, MOD)

    • Historical Version
  3. CAN/CSA C22.2 NO. 60601-2-43:11 (R2021) + A1:2019 (CONSOLIDATED)


    Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (Adopted IEC 60601-2-43:2010, second edition, 2010-03), Includes Update (2019)

    • Historical Version
  4. CAN/CSA C22.2 NO. 60601-2-43-03 (R2007)

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    Medical Electrical Equipment - Part 2-43: Particular Requirements for the Safety of X-Ray Equipment for Interventional Procedures (Adopted IEC 60601-2-43:2000, first edition, 2000-06)

    • Historical Version