AAMI 60601-2-2 pdf free download

AAMI 60601-2-2 pdf free download.Medical electrical equipment, Part 2-2: Particular requirements for the safety of high frequency surgical equipment.
For brevity, IEC 60601 -1 is referred to, in this Particular Standard, either as the “General Standard” or as the “General Requirement(s),” IEC 60601 -1 -1 , IEC 60601 -1 -2, and IEC 60601 -1 -4 as the Collateral Standard(s). The term “this Standard” covers the Particular Standard used together with the General Standard and any Collateral Standards. The numbering of sections, clauses, and subclauses of this Particular Standard corresponds with that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words: “Replacement” means that the clause or subclause of the General Standard is replaced completely by the text of this Particular Standard. “Addition” means that the text of this Particular Standard is additional to the requirements of the General Standard. “Amendment” means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard. Subclauses or figures which are additional to those of the General Standard are numbered starting from 1 01 , additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Clauses and subclauses for which there is a rationale are marked with an asterisk *. These rationales can be found in an informative Annex AA. Annex AA should be used in determining the relevance of the requirements addressed but should never be used to establish additional test requirements. Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard or Collateral Standards applies without modification. Where it is intended that any part of the General Standard or Collateral Standards, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard. A requirement of this Particular Standard, replacing or modifying requirements of the General Standard or Collateral Standards, takes precedence over the corresponding General Requirement(s).2.1.103 ACTIVE ELECTRODE part of an ACTIVE ACCESSORY extending from the ACTIVE HANDLE to the surgical site 2.1.104 ACTIVE HANDLE part of an ACTIVE ACCESSORY intended to be held by the OPERATOR *2.1.105 ASSOCIATED EQUIPMENT EQUIPMENT other than HF SURGICAL EQUIPMENT that may be electrically connected to the PATIENT CIRCUIT and not intended for independent use 2.1.106 BIPOLAR ELECTRODE assembly of two or more ACTIVE ELECTRODES on the same support, so constructed that, when energized, the HF current flows mainly between these two electrodes 2.1.107 CONTACT QUALITY MONITOR CQM circuit in HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT intended for connection to a MONITORING NE providing an alarm in the event that NE contact with the PATIENT becomes insufficient NOTE A CONTACT QUALITY MONITOR is functional only when used with a MONITORING NE.2.1.112 NE CONTINUITY MONITOR circuit in HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT intended for connection to an NE , except MONITORING NE , providing an alarm in the event of electrical discontinuity in the NE cable or its connections NOTE An NE CONTINUITY MONITOR is intended for use only with NE s other than MONITORING NE s. 2.1.113 NEUTRAL ELECTRODE NE electrode of a relatively large area for connection to the body of the PATIENT , intended to provide a return path for the HIGH FREQUENCY current with such a low current density in the body tissue that physical effects such as unwanted burns are avoided NOTE The NEUTRAL ELECTRODE is also known as plate, plate electrode, passive, return, or dispersive electrode.AAMI 60601-2-2  pdf download.