IEC 60601-2-45:2001
Collections
International IEC standards
Publication date
May 2001
Number of pages
42 p.
Reference
IEC 60601-2-45:2001
Print number
2
IEC 60601-2-45:2001
May 2001
International standard
Cancelled
Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
The object of this standard is1. to formulate appropriate design and manufacturing requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices, reflecting the particular characteristics and circumstances of use of such equipment;2. to establish particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements.It is the bilingual version of the english version published in 2001.
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Sumary
Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
The object of this standard is 1. to formulate appropriate design and manufacturing requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices, reflecting the particular characteristics and circumstances of use of such equipment; 2. to establish particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements. It is the bilingual version of the english version published in 2001.
The object of this standard is 1. to formulate appropriate design and manufacturing requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices, reflecting the particular characteristics and circumstances of use of such equipment; 2. to establish particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements. It is the bilingual version of the english version published in 2001.
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Standard replaced by
(1)
IEC 60601-2-45:2011
February 2011
International standard
Current
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
IEC 60601-2-45:2011 applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. Like the previous edition of this Part 2-45, the present third edition includes requirements on high-voltage generators for mammography. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rd edition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with respect to the current technology of mammographic X-ray equipment.
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