1 Scope
This part of YY 0068 specifies the requirements for mechanical properties and test methods of rigid endoscope.
This part is applicable to the medical rigid endoscope.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY 0068. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this part. However parties to agreements based on this part are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
YY 0068.1 Medical Endoscopes — Rigid Endoscope — Part 1: Optical Properties and Test Methods
3 Terms and Definitions
For the purposes of this part of YY 0068, the terms and definitions given in YY 0068.1 and the following apply.
3.1
endotherapy device
medical device intended to be inserted into a natural or surgically-created body opening during endoscopic procedures, whether through the same or a different orifice from the endoscope for examination, diagnosis or therapy
Note 1: Endotherapy devices include the instrument through which an endoscope or endotherapy device is inserted, such as a guide tube, trocar tube or sliding tube, etc. Endotherapy devices include the devices to be inserted through the openings other than the opening for an endoscope, to ensure the safety of the devices for the intended use under the endoscopic view.
Note 2: The term “endoscopically-used accessory” is used in 2.1.102 of GB 9706.19-2000.
Foreword II
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
5 Test Methods
