YY 0485-2004 Replaced Industry standards-Medicine

YY 0485-2004 Single use cardioplegia delivery system

YY 0485-2004 Single use cardioplegia delivery system

Publish Date: 2004-07-16 Implement Date: 2005-08-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0485-2004

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Medical hygiene products

ICS Name: Blood transfusion, infusion, and injection equipment

Publish Date: 2004-07-16

Implement Date: 2005-08-01

Pages: 7 pages

Scope

This standard specifies the structure and classification, requirements, test methods, inspection rules, marking, labeling, user manuals, packaging, transportation, and storage of disposable heart arrest fluid perfusion devices. This standard applies to disposable heart arrest fluid perfusion devices (hereinafter referred to as perfusion devices). The perfusion devices are used for heart arrest fluid perfusion during open-heart surgery in extracorporeal circulation; they are also suitable for perfusion systems for tissue and organ protection.

Development Information

Word Count: 11 Thousand words Pages: 7 pages

Superseded by the following standards

YY 0485-2011 Single-used cardioplegia delivery system

Referenced Standards

GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 2828.1-2003 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods GB/T 14437-1997 Single sampling procedures and tables by attributes for product quality audit GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB 18278-2000 Sterilization of health care products—Requirements for validation and routine control—Industrial moist heat sterilization GB 18279-2000 Medical devices—Validation and routine control of ethylene oxide sterilization GB 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization YY 0311-1998 General specification for single-use blood flow product 《医疗器械说明书管理规定》国家药品监督管理局第30号令

Related Standards

GB/T 4506-1984 Abolished

GB/T 4506-1984 Method for the test of sharpness and strength of needles tips

Publish Date: 1984-06-22

GB/T 11751-1989 Abolished

GB/T 11751-1989 Flexible polymeric tubes for medical use—Dimension

Publish Date: 1989-10-20

GB/T 12256-1990 Abolished

GB/T 12256-1990 Test method for stiffness of hypodermic needle tubing

Publish Date: 1990-01-08

GB/T 13074-1991 Replaced

GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration

Publish Date: 1991-07-17

GB 14232-1993 Abolished

GB 14232-1993 Bags for human blood and blood components

Publish Date: 1993-03-16

GB/T 14233.2-1993 Replaced

GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods

Publish Date: 1993-03-16