YY/T 0001-2008 Active Industry standards-Medicine

YY/T 0001-2008 Technical requirements of equipment for extracorporeally induced lithotripsy

Publish Date: 2008-04-25 Implement Date: 2009-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0001-2008

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical electronic instruments and equipment

ICS Name: Integrated medical equipment

Publish Date: 2008-04-25

Implement Date: 2009-12-01

Pages: 12 pages

Scope

This standard specifies the terms and definitions, product classification, technical requirements, test methods, inspection rules, and marking requirements for extracorporeal lithotripsy devices (defined in accordance with 3.1, hereinafter referred to as the device).
This standard applies to devices that use hydraulic-electric, electromagnetic, or piezoelectric pressure pulse generators as the lithotripsy wave source. The devices are primarily used for crushing urinary tract stones.

Development Information

Word Count: 17 Thousand words Pages: 12 pages

Replace the following standards

YY 0001-1990 Extracorporeal shock wave lithotripsy machine general technical specification

Referenced Standards

GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.22-2003 Medical electrical equipment—Part 2:Particular requirements for the safety of equipment for extracorporeally induced lithotripsy GB/T 19042.1-2003 Evaluation and routine testing in medical imaging departments—Part 3-1:Acceptance test—Imaging performance of X-ray equipment for radiographic and radioscopic systems GB 10152-1997 B mode ultrasonic diagnostic equipment GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 13384-1992 General specifications for packagings of mechanical and electrical products

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

GB/T 16886.3-1997 Replaced

GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

GB/T 16886.13-2001 Replaced

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24