YY/T 0708-2009 Abolished Industry standards-Medicine

YY/T 0708-2009 Medical electrical equipment—Part 1-4:General requirements for safety—collateral standard:programmable electrical medical systems

Publish Date: 2009-11-15 Implement Date: 2010-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0708-2009

Standard Type: Industry standards

Standard Status: Abolished

is_force_gb: no

CCS Name: Medical devices

ICS Name: Integrated medical equipment

Publish Date: 2009-11-15

Implement Date: 2010-12-01

Pages: 24 pages

Scope

This parallel standard applies to the safety requirements of medical electrical equipment and medical electrical systems equipped with programmable electronic subsystems (PESS), hereinafter referred to as programmable medical electrical systems (PEMS).
Note: Some systems with software used for medical purposes are beyond the scope of this parallel standard, such as many medical information systems. The identification elements (criteria) are: whether the system meets the definition of medical electrical equipment in GB 9706.1—2007 section 2.2.15, or the definition of medical electrical systems in GB 9706.15—2008 section 2.201.

Development Information

Word Count: 41 Thousand words Pages: 24 pages

Referenced Standards

GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.15-2008 Medical electrical equipment—Part1:General requirements for safety—1.Collateral standard:Safety requirements for medical electrical systems GB/T 19001-2000 Quality management systems—Requirements IEC 60788:1984

Adopt standards

IEC 60601-1-4:2000

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