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YY/T 0287-2003 (YYT 0287-2003)

Chinese standards (related to): 'YY/T 0287-2003'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)See DetailStatusGoogle Book
YY/T 0287-2017English145 Add to Cart 0--10 minutes. Auto immediate delivery. Medical devices -- Quality management systems -- Requirements for regulatory purposes YY/T 0287-2017 Valid YYT 0287-2017
YY/T 0287-2003English285 Add to Cart 0--10 minutes. Auto immediate delivery. Medical devices. Quality management systems. Requirements for regulatory purposes YY/T 0287-2003 Obsolete YYT 0287-2003
YY/T 0287-1996English519 Add to Cart Days<=3 Quality system—Medical devices—Particular requirements for the application of GB/T 19001—ISO 9001 YY/T 0287-1996 Obsolete YYT 0287-1996


   
BASIC DATA
Standard ID YY/T 0287-2003 (YY/T0287-2003)
Description (Translated English) Medical devices. Quality management systems. Requirements for regulatory purposes
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.01
Word Count Estimation 49,469
Date of Issue 2003-09-17
Date of Implementation 2004-04-01
Older Standard (superseded by this standard) YY/T 0287-1996
Quoted Standard GB/T 19000-2000
Adopted Standard ISO 13485-2003, IDT
Drafting Organization Medical Device Quality Management and General Requirements Standardization Technical Committee
Administrative Organization Medical Device Quality Management and General Requirements Standardization Technical Committee
Proposing organization State Food and Drug Administration Medical Devices Division
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the action of the quality management system requirements, organizations may so require a medical device design and development, production, installation and services, and related services to design, develop and deliver. This standard can also be used for internal and external (including certification bodies) to assess the organization to meet customer and regulatory requirements. This standard needs to demonstrate its ability to consistently meet customer requirements and to provide for medical devices and related services regulatory requirements for medical devices and related services organization defines the quality management system requirements. The main purpose of this standard is to facilitate the coordinated implementation of the quality management system regulations. Therefore, the standard specifies a number of requirements for medical devices, the deletion of GB/T 19001 suitable as regulatory requirements in certain requirements. Because of these deletion, the quality management system conforming to this standard organization can not claim to comply with GB/T 19001 standard, unless its quality management system also complies with GB/T 19001 All the requirements (see Appendix B).