Medical electrical equipment—Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This document applies to the basic safety and essential performance of laser equipment for surgical, therapeutic, medical diagnostic and cosmetic applications, classified as laser product of Class 1C where the enclosed laser is of Class 3B or 4, or Class 3B, or Class 4.
In this document, medical electrical equipment or medical electrical systems, which incorporate laser light as a source of energy being transferred to the patient, are referred to as "laser equipment".
Note 1: Laser products classified as Class 1, Class 1M, Class 2, Class 2M or Class 3R in these applications are covered by GB 7247.1-2012 and general standards.
If a clause or subclause applies to ME equipment only or ME systems only, it shall be clearly specified in the title and content of the clause or subclause. Otherwise, this clause or subclause applies to the relevant ME equipment and ME systems.
Hazards inherent in the intended physiological function of laser equipment within the scope of this document are not covered by specific requirements in this document except in 7.2.13 "Physiological effects" of the general standard.
Note 2: See also 4.2, Risk management process for ME equipment or ME system, of the general standard.
Note 3: If a laser device is classified as Class 1C and is used as a household laser appliance, it is covered by IEC 60335-2-113:2016.
201.1.2 Object
Replacement:
The object of this document is to specify safety-specific requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard.
201.1.4 Particular standards
Addition:
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 document as the general standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this document 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. 202.4 in this document addresses the content of Clause 4 of the YY 9706.102 collateral standard, and 203.4 in this document addresses the content of Clause 4 of the GB 9706.103 collateral 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 or applicable collateral standard is replaced completely by the text of this document.
"Addition" means that the text of this document 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 document.
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 final digit of the collateral standard number, e.g. 202 for YY 9706.102, 203 for GB 9706.103.
The term "this standard" is used to make reference to the general standard, any applicable collateral standards and this document taken together.
Where there is no corresponding clause or subclause in this document, 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 document.
Concerning laser radiation safety of laser equipment, GB 7247.1-2012 applies, except for the relevant requirements that are specified, changed or amended in this document.
201.2 Normative references
Foreword II
Introduction VIII
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 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 Hazardous 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
Annexes
Annex D (Informative) Symbols on marking
Annex AA (Informative) Particular guidance and rationale
Bibliography
