Customer Support: 131 242

  • Shopping Cart
    There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert
Celebrate World Standards Day. Save 10% with code WSD2026 until 31 Oct. Save now

BS EN 60601-2-43:2010

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by

Medical electrical equipment Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-10-2014

Withdrawn date

28-05-2021

$737.91
Including GST where applicable
Summarise this standard

INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT
       and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
       HAZARDS
201.11 Protection against excessive temperatures and other
       HAZARDS
201.12 Accuracy of controls and instruments and protection
       against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME
       SYSTEMS
202 Electromagnetic compatibility - Requirements and tests
203 Radiation protection in diagnostic X-ray equipment
Annexes
Annex AA (informative) - Particular guidance and rationale
Annex BB (normative) - Distribution maps of STRAY RADIATION
Annex CC (informative) - Mapping between this Edition 2 of
         IEC 60601-2-43 and Edition 1
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications
Annex ZZ (informative) - Coverage of Essential Requirements of
         EC Directives
Bibliography
Index of defined terms used in this particular standard

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT.

Committee
CH/62/2
DevelopmentNote
Supersedes 98/564807 DC. (05/2005) Supersedes 08/30151689 DC. (07/2010)
DocumentType
Standard
Pages
122
PublisherName
British Standards Institution
Status
Withdrawn
SupersededBy
Supersedes

⚠

A newer version of this standard is available.

$737.91
Including GST where applicable