BS EN 60601-2-65:2013+A1:2020
$198.66
Medical electrical equipment – Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 52 |
Clause 1 of the general standard1 applies, except as follows:
201.1.1 Scope
Replacement:
This International Standard applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components, hereafter also called me equipment.
The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly.
Dental extra-oral X-ray equipment is excluded from the scope of this standard
NOTE 1 The X-ray generator in dental intra-oral X-ray equipment always comprises an X-ray monoblock assembly. Therefore in this particular standard the concept of X-ray tube assembly is replaced by that of X-ray monoblock assembly.
NOTE 2 Main components may be for instance the X-ray monoblock assembly and an electronic X-ray image receptor.
NOTE 3 Photostimulated phosphor plates and their readers (hardware and software) are excluded from the scope of this particular standard, since they have no electrical applied parts in the patient environment, and are not me equipment.
Me equipment and me systems in the scope of IEC 60601‑2‑63, IEC 60601‑2‑44, IEC 60601‑2‑54, IEC 60601‑2‑45 or IEC 60601‑2‑43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes radiotherapy simulators and equipment for bone or tissue absorption densitometry. Excluded from the scope is also me equipment intended to be used for dental radioscopy.
Within its specific scope, the clauses of this particular standard supersede and replace those of IEC 60601‑2‑7, Medical electrical equipment – Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601‑2‑32, Medical electrical equipment – Particular requirements for the safety of associated equipment of X-ray equipment.
NOTE 4 Requirements for X-ray generators and for associated equipment, which were previously specified in IEC 60601‑2‑7 and IEC 60601‑2‑32, have been included in either IEC 60601‑1:2005 (Ed3) or in this particular standard. Therefore IEC 60601‑2‑7 and IEC 60601‑2‑32 are not part of the IEC 60601‑1 3rd edition scheme for dental intra-oral x-ray equipment.
All requirements addressing integrated X-ray tube assemblies are covered by this particular standard. Therefore IEC 60601‑2‑28 does not apply to me equipment in the scope of this International Standard.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular basic safety and essential performance requirements for me equipment for dental intra-oral radiography.
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.
IEC 60601‑1‑2 and IEC 60601‑1‑3 apply as modified in Clauses 202 and 203 respectively. IEC 60601‑1‑8, IEC 60601‑1‑102, IEC 60601‑1‑113 and IEC 60601‑1‑124 do not apply. All other published collateral standards in the IEC 60601‑1 series apply as published.
NOTE Operators of dental intra-oral X-ray equipment are used to audible signals as required in this particular standard rather than to the concepts of IEC 60601‑1‑8. Therefore IEC 60601‑1‑8 does not apply.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard or 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, IEC 60601‑1 is referred to in this particular 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 standard 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 particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 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 3.139, additional definitions in this standard 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 IEC 60601‑1‑2, 203 for IEC 60601‑1‑3, etc.
The term “this standard” 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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 8 | CONTENTS |
| 12 | INTRODUCTION INTRODUCTION TO AMENDMENT 1 |
| 13 | 201.1 Scope, object and related standards |
| 15 | 201.2 Normative references 201.3 Terms and definitions |
| 17 | 201.4 General requirements 201.5 General requirements for testing of me equipment 201.6 Classification of me equipment and me systems Tables Table 201.101 – List of potential essential performance to be considered by manufacturer in the risk management process |
| 18 | 201.7 ME equipment identification, marking and documents |
| 20 | 201.8 Protection against electrical hazards from me equipment |
| 21 | 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 |
| 22 | 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.13 Hazardous situations and fault conditions 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 compatibility – Requirements and tests |
| 23 | 203 Radiation protection in diagnostic X-ray equipment |
| 33 | Annexes |
| 34 | Annex C (informative) Guide to marking and labeling requirements for me equipment and me systems Table 201.C.101 – Marking on the outside of me equipment or its parts Table 201.C.102 – Subclauses requiring statements in accompanying documents |
| 35 | Annex AA (informative) Particular guidance and rationale |
| 36 | Figures Figure AA.1 – air kerma during irradiation with direct current x-ray generator |
| 38 | Figure AA.2 – Air kerma during irradiation with onepeak xray generator |
| 39 | Figure AA.3 – Waveform of long irradiation time X-radiation from a onepeak xray generator |
| 42 | Annex BB (informative) Identification of parts of dental X-ray intra-oral systems in relation to defined terms in this standard Figure BB.1 – Structure of dental intra-oral x-ray equipment |
| 43 | Figure BB.2 – Parts of dental intra-oral x-ray equipment |
| 44 | Bibliography |
| 47 | Index of defined terms used in this particular standard |
