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Description of BS EN IEC 60601-2-31:2020 2023IEC 60601-2-31:2020 is available as IEC 60601-2-31:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-31:2020 applies to the BASIC SAFETY and ESSENTIAL
PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL
ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT.
This document applies to PATIENT CABLES as defined in 201.3.209,
but does not apply to LEADS as defined in 201.3.206. HAZARDS
inherent in the intended physiological function of ME EQUIPMENT
within the scope of this document are not covered by specific
requirements in this document except in 7.2.13 and 8.4.1 of the
general standard. This document does not apply to the implantable
parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1.
This document does not apply to EXTERNAL PACEMAKERS which can be
connected directly or indirectly to a SUPPLY MAINS. This document
does not apply to transthoracic and oesophageal pacing ME EQUIPMENT
and antitachycardia ME EQUIPMENT. IEC 60601-2-31:2020 cancels and
replaces the second edition published in 2008 and Amendment 1:2011.
This edition constitutes a technical revision. This edition
includes the following significant technical changes with respect
to the previous edition:
About BSIBSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses. |
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