This Standard specifies the requirements and test methods of carbon dioxide insufflators for medical endoscope. This Standard applies to the carbon dioxide insufflators that is used in the endoscopic surgery. The product is used to establish and maintain the pneumoperitoneum in minimally invasive endoscopic surgery. 2 Normative references The articles contained in the following documents have become part of this document when they are quoted herein. For the dated documents so quoted, all the modifications (including all corrections) or revisions made thereafter shall be applicable to this document. GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety GB 9706.19-2000 Medical electrical equipment - Part 2. Particular requirements for the safety of endoscopic equipment
Basic Data
Standard ID
YY 0843-2011 (YY0843-2011)
Description (Translated English)
Medical endoscopes - Endoscope supply units - Insufflators
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard
C40
Classification of International Standard
11.040.99
Word Count Estimation
12,184
Date of Issue
2011-12-31
Date of Implementation
2013-06-01
Quoted Standard
GB 9706.1-2007; GB 9706.19-2000
Regulation (derived from)
State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies requirements for medical endoscope with carbon dioxide pneumoperitoneum requirements and test methods. This standard applies to the use of endoscopic surgery of carbon dioxide pneumoperitoneum. The products are used in minimally invasive endoscopic surgery pneumoperitoneum established and maintained.
