YY/T 0202-2009Specifications for medical diagnostic X-ray device for tomography (English PDF)

Foreword

This standard replaces YY/T 0202-2004 "Medical diagnostic X-ray tomography device".

The main changes in this standard compared with YY/T 0202-2004 are as follows.

--- modified the standard name, the "medical diagnostic X-ray tomography device" to "medical diagnostic X-ray tomography device technology Technical requirements ";

--- The safety requirements should be changed to meet the requirements of GB 9706.1, GB 9706.14 and YY 0505-2005. Deleted the original Appendix A;

- the inspection rules, instructions, signs, labels, packaging, transportation and storage are removed;

--- Test device icon as a data Appendix A; original Appendix A to Appendix B.

--- on the other content to do some text on the changes. Appendix A and Appendix B of this standard are informative.

1 Scope

This standard specifies the terminology and definitions, classification, requirements, and requirements of medical diagnostic X-ray tomography devices (hereinafter referred to as body photographic devices) experiment method.

This standard is applicable to medical diagnostic X-ray machines with longitudinal tomography.

This standard does not apply to computer tomography (CT) and maxillofacial tomography.

2 Normative reference documents

The terms of the following documents are hereby incorporated by reference into this standard. Whichever is the date of the reference file, which is followed by all (Excluding corrigenda) or revisions do not apply to this standard, however, encourage the parties to reach an agreement under this standard Whether you can use the latest version of these files. For undated references, the latest edition applies to this standard.

GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)

GB 9706.14-1997 Medical electrical equipment - Part 2. Particular requirements for the safety of ancillary equipment for X - ray equipment (Idt IEC 60601-2-32.:1994)

GB/T 10149 Medical X - ray equipment - Terms and symbols X - ray photography cartridges Technical specification for coating classification of metal parts YY 0076-1992 General specification for medical diagnostic X - ray machines YY/T 0106-2008 Medical environmental requirements and test methods for medical X - ray equipment YY/T 0291-2007

YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests (IEC 60601-1-2.:2001, IDT)

3 Terms and definitions

The terminology and definitions established in GB/T 10149 apply to this standard, except as follows. […]