YY 0001-2008 English PDF

US$439.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 0001-2008: Technical requirements of equipment for extracorporeally induced lithotripsy
Status: Obsolete

YY 0001: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0001-2008	439	Add to Cart	3 days	Technical requirements of equipment for extracorporeally induced lithotripsy	Obsolete
YY 0001-1990	759	Add to Cart	5 days	General technical requirements for extracorporeal shock wave lithotripter	Obsolete

Similar standards

YY/T 1933   YY/T 1712   YY/T 1519   YY 9706.256   YY 9706.231   

Basic data

Standard ID: YY 0001-2008 (YY0001-2008)
Description (Translated English): Technical requirements of equipment for extracorporeally induced lithotripsy
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C39
Classification of International Standard: 11.040.01
Word Count Estimation: 11,132
Date of Issue: 2008-04-25
Date of Implementation: 2009-12-01
Older Standard (superseded by this standard): YY 0001-1990
Quoted Standard: GB 9706.1-2007; GB 9706.22-2003; GB/T 19042.1-2003; GB 10152-1997; GB/T 14710-1993; GB/T 191-2008; GB/T 13384-1992
Regulation (derived from): SFDA [2008] No. 192
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the in vitro induced lithotripsy equipment (by 3. 1 definition, hereinafter referred to as the device) the terms and definitions, product classification, technical requirements, test methods, inspection rules and signs and other requirements. This standard applies to hydro-electric, electromagnetic, piezoelectric pressure pulse generator of gravel wave source equipment, crushing equipment, mainly used for urinary calculi.

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

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Technical requirements of equipment for extracorporeally induced lithotripsy ICS 11.040.01 C39 People's Republic of China pharmaceutical industry standards Replacing YY 0001-1990 In vitro initiation Crushing Equipment Technical Requirements Posted 2008-04-25 2009-12-01 implementation State Food and Drug Administration issued

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. This standard was proposed by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee. This standard by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee. This standard was drafted. Shanghai Medical Device detection. The main drafters of this standard. and Yu. This standard replaces the standards previously issued as follows. --- YY 0001-1990. In vitro initiation Crushing Equipment Technical Requirements

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. 3.1 Pressure pulse therapy device in vitro by initiation. 3.2 In the high-voltage discharge liquid pressure pulse device. 3.3 The coil in the electromagnetic field caused by changes in metal membrane vibration generated pressure pulse device. 3.4 By the inverse piezoelectric effect, so that each of the plurality of piezoelectric wafer to produce a small pressure pulse energy, and to gravel devices converging at the focal point. 3.5 Body not in direct contact with water, using bladders coupled crushing equipment. ......

Image     

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY 0001-2008_English be delivered?

Answer: Upon your order, we will start to translate YY 0001-2008_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY 0001-2008_English with my colleagues?

Answer: Yes. The purchased PDF of YY 0001-2008_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version YY 0001-2008?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0001-2008 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.