武汉金柏威光电技术有限公司

Goldbov Photoelectronics Co., Ltd

Bibliographic references

Reference Standard
1) YY/T0294.1-2005 Surgical instruments Metal materials -Part 1: Stainless steel
2) GB9706.1-2007 Medical electrical equipment - Part 1:General safety requirements
3) GB9706.4-2009 Medical electrical equipment Part 2-2: Special requirements for high-frequency surgical
equipment safety
4) YY0505-2012 Medical Electrical Equipment Part 1-2: Safety General Requirements Parallel Standards;
Electromagnetic Compatibility Requirements and Tests;
5) GB/T4340.1-2009 metal materials Vickers hardness test Part 1: Test methods
6) GB/T14233.2-2005 Medical infusion, blood transfusion, injection test methods - Part 2:Biological test method
7) GB/T16886.1-2011 Biological evaluation of medical devices-Part 1: Evaluation and testing
8) GB/T16886.5-2003 Biological evaluation of medical devices - Part 5: In vitro cytotoxicity test
9) GB/T16886.10-2005 Biological evaluation of medical devices - Part 10: Stimulation and delayed type
hypersensitivity test
10) GB/T191-2008 packaging storage and transportation icon
11) GB/T 2828.1-2012 Counting sampling inspection procedures Part 1: Batch-by-batch sampling plan searched
by the acceptance quality limit (AQL)
12) GB/T 4240-2009 stainless steel
13) YY/T0149-2006 Stainless steel medical equipment Test method for corrosion resistance
14) YY/T0466-2009 Medical Devices Symbols for labeling, marking and providing information for medical devices
15) YY/T0316-2008 Medical Device Risk Management for Medical Devices
16) YY/T0287-2003 Medical Device Quality Management System for Regulatory Requirements

Add: Caifu Road1, EastⅡIndustrial Park, East Lake High-Tech Development Zone, 430073,Wuhan, P.R.China.
Tel: +86-27-87985800 Fax: +86-27-87407212 Web: http://www.goldbov.com Email: sales@goldbov.com