GB 9706.19-2000: Medical electrical equipment. Part 2: Particular requirements for the safety of endoscopic equipment

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Scope

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 ELECTRICAL 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 is 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 IEC publications, hereinafter referred
to as “General Standard”, consisting of GB 9706.1-1995 Medical electrical equipment - Part
1: General requirements for safety; IEC 60601-1:1998Medical electrical equipment - Part 1:
General requirements for safety, amendment 2; IEC 60601-1-1:1992 Medical electrical
equipment - Part 1: General requirements for safety, 1: Collateral Standard: Safety
requirements for medical electrical systems, amendment 1; and IEC 60601-1-2: 1993 Medical
electrical equipment - Part I : General requirements for safety, 2: Collateral standard:
Electromagnetic compatibility - Requirements and tests.
GB 9706.1-1995 and IEC 60601-1:1998 Amendment 2 is 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.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
Clauses and subclauses to which there is a rationale are marked with an asterisk *. These
rationales can be found in an informative annex AA. Annex AA is not part of this Particular
Standard and only gives additional information; it can never be the subject of testing.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard or Collateral Standard applies without
modification.
Where it is intended that any part of the General Standard or Collateral Standards, although
possibly irrelevant, is not to be applied, a statement to that effect is given in this Particular
Standard.
A requirement of this Particular Standard replacing or modifying requirements of the General

Basic Data

Standard ID	GB 9706.19-2000 (GB9706.19-2000)
Description (Translated English)	Medical electrical equipment. Part 2: Particular requirements for the safety of endoscopic equipment
Sector / Industry	National Standard
Classification of Chinese Standard	C40
Classification of International Standard	11.040.50
Word Count Estimation	18,195
Date of Issue	2000-07-12
Date of Implementation	2000-12-01
Adopted Standard	IEC 60601-2-18-1996, IDT
Issuing agency(ies)	State Quality and Technical Supervision
Summary	This Chinese standard provides specific endoscopic equipment and endoscopic accessories interconnection conditions security requirements.