BS EN IEC 80601-2-60:2020
$189.07
Medical electrical equipment – Particular requirements for the basic safety and essential performance of dental equipment
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 50 |
Clause 1 of the general standard1 applies, except as follows:
201.1.1 Scope
Replacement:
This part of IEC 80601 applies to the basic safety and essential performance of dental units, dental patient chairs, dental handpieces and dental operating lights, hereafter referred to as dental equipment.
If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant.
Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
201.1.2 Object
Replacement:
The object of this particular standard is to establish basic safety and essential performance requirements for dental equipment (as defined in 201.3.202.)
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 60601‑1‑3 and IEC 60601‑1‑10 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 IEC 60601 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, IEC 60601‑1:2005 and IEC 60601‑1:2005/AMD1:2012 are 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 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 particular standard addresses the content of Clause 4 of the IEC 60601‑1‑2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 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 3.147, 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 IEC 60601‑1‑2, 203 for IEC 60601‑1‑3, 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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 7 | Annex ZA(normative)Normative references to international publicationswith their corresponding European publications |
| 9 | English CONTENTS |
| 10 | FOREWORD |
| 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 201.7 Me equipment identification, marking and documents |
| 18 | 201.8 Protection against electrical hazards from me equipment |
| 19 | Tables Table 201.101 – Test voltages for solid insulationfor secondary circuits according to 201.8.9.1.12 |
| 23 | 201.9 Protection against mechanical hazards of me equipment and me systems |
| 25 | Table 201.102 – Determination of tensile safety factor |
| 26 | 201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards Table 201.103 – Mass distribution |
| 27 | Table 201.104 – Allowable maximum temperaturesfor the operator side of dental handpieces |
| 30 | 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.13 Hazardous situations and fault conditions for me equipment |
| 31 | 201.14 Programmable electrical medical systems (pems) 201.15 Construction of me equipment |
| 32 | 201.16 Me systems 201.17 Electromagnetic compatibility of me equipment and me systems 201.101 Cordless hand-held and foot-operated control devices |
| 33 | Annexes |
| 34 | Annex AA (informative)Particular guidance and rationale |
| 35 | Figures Figure AA.1 – Example of applied parts for dental equipment |
| 36 | Figure AA.2 – Calculation of leakage current |
| 38 | Figure AA.3 – Insulation problem of commutator dental electrical motor |
| 39 | Table AA.1 – Rated impulse voltage for equipment energized directlyfrom the low-voltage mains |
| 44 | Figure AA.4 – Loading fan construction Figure AA.5 – Load diagram with loading fan |
| 46 | Bibliography |
| 47 | Index of defined terms used in this document |
