Medical electrical equipment—Part 2-2: Particular requirements for the safety of high frequency surgical equipment
SECTION ONE - GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
*1.1 Scope
Addition:
This Particular Standard specifies requirements for the safety of HIGH FREQUENCY SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES used in medical practice, as defined in 2.1.110 and hereinafter referred to as HF SURGICAL EQUIPMENT.
HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this Particular Standard. These exemptions are indicated in the relevant requirements.
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety of HF SURGICAL EQUIPMENT.
1.3 Particular Standards
Addition:
This Particular Standard amends and supplements a set of IEC publications consisting of
GB 9706.1-2007 Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1: 1988, IDT)
GB 9706.15-2008 Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1: 2000, IDT)
YY 0505-2005 Medical electrical equipment - Part 1-2:General requirements for safety - Collateral standards: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2: 2001, IDT)
IEC 60601-1-4: 1996 Medical electrical equipment – Part 1: General requirements for safety – 4. Collateral Standard: Programmable electrical medical systems Amendment 1 (1999)
For brevity, GB 9706.1 is referred to, in this Particular Standard, either as the “General Standard” or as the “General Requirement(s)”, GB 9706.15, YY 0505-2005, 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 101, 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 may be used in determining the relevance of the requirements addressed but shall 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 Terminology and definitions
This clause of the General Standard applies except as follows:
Addition:
2.1.101
active accessory
HF SURGICAL ACCESSORY intended for manipulation by the OPERATOR to produce surgical effects at the intended site on the PATIENT, generally comprising an ACTIVE HANDLE, active cord, ACTIVE CONNECTOR and ACTIVE ELECTRODE
2.1.102
active connector
part of an ACTIVE ACCESSORY intended for connection to an ACTIVE OUTPUT TERMINAL, which may include additional terminals for connection of a FINGERSWITCH to a SWITCH SENSOR
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.
2.1.108
endoscopically used accessory
an accessory, which may be the APPLIED PART of MEDICAL ELECTRICAL EQUIPMENT that is not ENDOSCOPIC EQUIPMENT, introduced into a patient through the same orifice in the PATIENT as the ENDOSCOPE
2.1.109
fingerswitch
device generally included with an ACTIVE ACCESSORY which, when manipulated by the OPERATOR, enables HF output to be produced and, when released disables HF output
Note: Requirements for similar switches intended to perform functions other than activation of HF output are under consideration.
2.1.110
HF surgical accessory
ACCESSORY intended to conduct, supplement or monitor HF energy applied to the PATIENT from HF SURGICAL EQUIPMENT
Note: HF SURGICAL ACCESSORIES include HF surgical application electrodes, including cords and connectors for attachment to HF SURGICAL EQUIPMENT, as well as other ASSOCIATED EQUIPMENT intended for connection to the HF surgical PATIENT CIRCUIT.
2.1.111
monitoring NE
NEUTRAL ELECTRODE (NE) intended for use with a CONTACT QUALITY MONITOR
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 NEs other than MONITORING NEs.
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
Foreword I
Introduction III
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
4 General requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRICAL SHOCK HAZARDS
14 Requirements related to classification
17 Separation
18 Protective earthing, functional earthing and potential equalization
19* Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
20* Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
36 Electromagnetic compatibility
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
39 Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42* Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
46 Human errors
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
59 Construction and layout
Annex L References Publications mentioned in this standard
Annex AA (informative) Guidance and rationale for particular clauses and subclauses
Annex BB (informative) Electromagnetic disturbances created by HF SURGICAL EQUIPMENT
