1 Scope and object
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
