GB 9706.202-2021 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (English Version)
Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
GB 9706.202-2021 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
201.1 Scope, object and related standards
Clause 1 of the general standard1 applies, except as follows:
201.1.1 * Scope
Replacement:
This part applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES.
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.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard.
YY 9706.102 and YY 9706.108 apply as modified in Clauses 202 and 208 respectively. GB 9706.103, YY/T 9706.110 and YY 9706.111 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the GB 9706 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, GB 9706.1-2020 is referred to in this standard as the general standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.6 in this standard addresses the content of Clause 6 of the YY 9706.102 collateral standard, 208 in this standard addresses the content of YY 9706.108 collateral standard, etc.).
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 or applicable collateral 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 or applicable collateral standard.
“Amendment” means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for YY 9706.102, 203 for YY 9706.108, etc.
The term “this document” is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.
201.2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
Clause 2 of the general standard applies, except as follows:
Replacement:
YY 9706.102-2021 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
YY 9706.108-2021 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Addition:
GB 4824-2019 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in the general standard and the following apply.
Replace NOTE 1 with the following:
NOTE 1: Where the terms “voltage” and “current” are used in this document, they mean the RMS values of an alternating, direct or composite voltage or current averaged over 1 s unless stated otherwise.
Addition:
201.3.201
ACTIVE ACCESSORY
HF SURGICAL ACCESSORY intended for manipulation by the OPERATOR to produce an effect by electrical conduction adjacent to the ACTIVE ELECTRODE at the intended site on the PATIENT, generally comprising an ACTIVE HANDLE, the cord of an ACTIVE ACCESSORY, ACTIVE CONNECTOR and ACTIVE ELECTRODE
201.3.202
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
201.3.203
ACTIVE ELECTRODE
part of an ACTIVE ACCESSORY extending from the ACTIVE HANDLE to the surgical site and intended to pass HF current into body tissue
201.3.204
ACTIVE ELECTRODE INSULATION
electrical insulation material affixed to part of an ACTIVE ELECTRODE intended to prevent unintended injury to PATIENT tissue or the OPERATOR
201.3.205
Contents
Foreword i
Introduction vi
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 H AZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
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 DISTURBANCES – Requirements and tests
208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Annex
Annex AA (Informative) Particular guidance and rationale
Annex BB (Informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICAL EQUIPMENT
Bibliography
GB 9706.202-2021 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (English Version)
Standard No.
GB 9706.202-2021
Status
valid
Language
English
File Format
PDF
Word Count
30500 words
Price(USD)
915.0
Implemented on
2023-5-1
Delivery
via email in 1 business day
Detail of GB 9706.202-2021
Standard No.
GB 9706.202-2021
English Name
Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
GB 9706.202-2021 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
201.1 Scope, object and related standards
Clause 1 of the general standard1 applies, except as follows:
201.1.1 * Scope
Replacement:
This part applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES.
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.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard.
YY 9706.102 and YY 9706.108 apply as modified in Clauses 202 and 208 respectively. GB 9706.103, YY/T 9706.110 and YY 9706.111 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the GB 9706 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, GB 9706.1-2020 is referred to in this standard as the general standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.6 in this standard addresses the content of Clause 6 of the YY 9706.102 collateral standard, 208 in this standard addresses the content of YY 9706.108 collateral standard, etc.).
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 or applicable collateral 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 or applicable collateral standard.
“Amendment” means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for YY 9706.102, 203 for YY 9706.108, etc.
The term “this document” is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.
201.2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
Clause 2 of the general standard applies, except as follows:
Replacement:
YY 9706.102-2021 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
YY 9706.108-2021 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Addition:
GB 4824-2019 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in the general standard and the following apply.
Replace NOTE 1 with the following:
NOTE 1: Where the terms “voltage” and “current” are used in this document, they mean the RMS values of an alternating, direct or composite voltage or current averaged over 1 s unless stated otherwise.
Addition:
201.3.201
ACTIVE ACCESSORY
HF SURGICAL ACCESSORY intended for manipulation by the OPERATOR to produce an effect by electrical conduction adjacent to the ACTIVE ELECTRODE at the intended site on the PATIENT, generally comprising an ACTIVE HANDLE, the cord of an ACTIVE ACCESSORY, ACTIVE CONNECTOR and ACTIVE ELECTRODE
201.3.202
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
201.3.203
ACTIVE ELECTRODE
part of an ACTIVE ACCESSORY extending from the ACTIVE HANDLE to the surgical site and intended to pass HF current into body tissue
201.3.204
ACTIVE ELECTRODE INSULATION
electrical insulation material affixed to part of an ACTIVE ELECTRODE intended to prevent unintended injury to PATIENT tissue or the OPERATOR
201.3.205
Contents of GB 9706.202-2021
Contents
Foreword i
Introduction vi
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 H AZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
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 DISTURBANCES – Requirements and tests
208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Annex
Annex AA (Informative) Particular guidance and rationale
Annex BB (Informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICAL EQUIPMENT
Bibliography
