YY 0001-2008Technical requirements of equipment for extracorporeally induced lithotripsy (English PDF)

Foreword

This standard replaces YY 0001-1990 "extracorporeal shock wave lithotripsy machine general technical conditions." This standard YY 0001-1990 major differences are.

--- Standard name modification;

--- Safety requirements for the modification according to GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" execution;

--- Environmental testing requirements modified to press GB/T 14710-1993 "Medical electrical equipment environmental requirements and test methods" execution;

--- Updated the outdated reference standard;

--- Remove 3.1 terminology;

--- Increasing the number of terms;

--- Remove the technical requirements for the non-technical content 5.1;

--- 5.4.1 and 5.4.4 of the index change is given by the manufacturer;

--- 5.4.11 change the recommended;

--- Remove the technical requirements of 5.4.12,5.4.14,5.6.1,5.6.3,5.6.4,5.6.5;

--- Deleted 8.3. Appendix A of this standard is an informative annex.

1 Scope

This standard specifies the initiation in vitro lithotripsy device (3.1 by definition, hereinafter referred to as the device) terms and definitions, product classifications, technical to Requirements, test methods, inspection rules and signs and other requirements.

This standard applies to liquid electrical, electromagnetic, piezoelectric pressure pulse generator gravel wave source device, the device is mainly used for crushing bleeding Urinary tract stones.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.

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

GB 9706.22-2003 Medical electrical equipment - Part 2. In vitro initiation of equipment for safety (IEC 60601-2-36:1997, MOD)

Evaluation of GB/T 19042.1-2003 medical imaging departments and routine testing - Part 3-1. X-ray photography and fluoroscopy systems X-ray imaging equipment performance acceptance test (IEC 61223-3-1:1999, IDT)

GB 10152-1997 B-type ultrasonic diagnostic equipment

GB/T 14710-1993 Medical electrical equipment environmental requirements and test methods

GB/T 191-2008 Packaging - Pictorial signs

GB/T 13384-1992 mechanical and electrical products packaging General technical conditions

3 Terms and Definitions

The following terms and definitions apply to this standard.