This clause of the General Standard applies, except as follows:
1.1 Scope
Addition:
This Particular Standard specifies requirements for the safety of endoscopic equipment and its interconnection conditions with endoscopically-used accessories.
Note: As the General Standard does not give requirements for the safety of applied parts of different medical electric equipment when used together, this standard gives requirements for specific interconnection conditions commonly encountered during the use of endoscopes.
1.2 Object
Replacement:
The object of this Particular Standard to establish particular requirements for the safety of endoscopic equipment and enable parts of endoscopic equipment to be tested together or individually.
1.3 Particular standards
Addition:
This Particular Standard amends and supplements a set of national standards and IEC publications, hereinafter referred to as “General Standard”, consisting of
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This Particular Standard amends and supplements a set of national standards and IEC publications, hereinafter referred to as “General Standard”, consisting of
GB 9706.1-1995 Medical electrical equipment—Part 1: General requirements for safety; IEC 60601-1:1998 Medical electrical equipment—Part 1: General requirements for safety, amendment 2; IEC 60601-1-1:1992 Medical electrical equipment—Part 1: Collateral Standard: Safety requirements for medical electrical systems, amendment 1; and IEC 60601-1-2:1993 Medical electrical equipment—Part 1: General requirements for safety, 2. Collateral standard: Electromagnetic compatibility—Requirements and tests.
For brevity, GB 9706.1-1995 and IEC 60601-1:1998, amendment 2 are referred to in this Particular Standard either as the “General Standard” or as the “General Requirement (s) ”, and IEC 60601-1-1:1992 and IEC 60601-1-2:1993 as the “Collateral Standards”.
The term “this Standard" covers this Particular Standard, used together with the General Standard and 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 of subclause of the General Standard is amended as indicated by the text of this Particular Standard.
Contents Foreword i IEC foreword ii 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 Section two—Environmental conditions Section three—Protection against electric shock hazards 20 Dielectric strength Section four—Protection against mechanical hazards 21 Mechanical strength 22 Moving parts 25 Expelled parts 26 Vibration and noise 27 Pneumatic and hydraulic power 28 Suspended masses Section five—Protection against hazards from unwanted or excessive radiation 36 Electromagnetic compatibility Section six— Protection against hazards of ignition of flammable anaesthetic mixtures 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 Section eight— Accuracy of operating data and protection against hazardous output Section nine— Abnormal operation and fault conditions; environmental tests Section ten—Constructional requirements 57 Main parts, components and layout Figure 101 Identification of light emission part Figure 102 Measurement of capacitively coupled HF current through the eyepiece Annex D Symbols on marking Annex AA (informative) Rationale Annex L References—Publications mentioned in this standard
