YY/T 0708-2009: Medical electrical equipment. Part 1-4: General requirements for safety. Collateral standard: Programmable electrical medical systems

Delivery: 9 seconds. Download (and Email) true-PDF + Invoice.
Get Quotation: Click YY/T 0708-2009 (Self-service in 1-minute)
Newer / historical versions: YY/T 0708-2009

Preview True-PDF

Scope

A requirement in a Particular Standard takes priority over the corresponding
requirement in this Collateral Standard.
2.201 Terminology and definitions
For the purpose of this Collateral Standard, the following terminology and
definitions apply. In this Collateral Standard, terms printed in CAPITALS are
used in accordance with their definitions in the General Standard, GB 9706.15,
this Collateral Standard or IEC 60788.1984.

Basic Data

Standard ID	YY/T 0708-2009 (YY/T0708-2009)
Description (Translated English)	Medical electrical equipment. Part 1-4: General requirements for safety. Collateral standard: Programmable electrical medical systems
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	25,263
Date of Issue	2009-11-15
Date of Implementation	2010-12-01
Quoted Standard	GB 9706.1-2007; GB 9706.15-2008; GB/T 19001-2000; IEC 60788-1984
Adopted Standard	IEC 60601-1-4-2000, IDT
Regulation (derived from)	Industry standard filing Notice 2010 No. 2 (No. 122 overall)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard applies with programmable electronic subsystems (PESS) medical electrical equipment and medical electrical systems [hereinafter referred to as programmable medical electrical systems (PEMS)] security requirements.