YY 0604-2007 Replaced Industry standards-Medicine

YY 0604-2007 Cardiovascular implants and artificial organs—Blood-gas exchangers(oxygenators)

YY 0604-2007 Cardiovascular implants and artificial organs—Blood-gas exchangers(oxygenators)

Publish Date: 2007-01-31 Implement Date: 2008-02-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0604-2007

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2007-01-31

Implement Date: 2008-02-01

Pages: 14 pages

Scope

This standard specifies the requirements for sterile, single-use extracorporeal circulation blood gas exchangers (oxygenators) (hereinafter referred to as oxygenators), which are used to supply oxygen to human blood and remove carbon dioxide from the blood. This standard also applies to heat exchangers that are an integral part of oxygenators. This standard does not apply to: — implantable oxygenators; — liquid oxygenators; — extracorporeal circulation pipes; — separate heat exchangers; — separate accessories.

Development Information

Word Count: 23 Thousand words Pages: 14 pages

Superseded by the following standards

YY 0604-2016 Cardiopulmonary bypass systems—Blood-gas exchangers(oxygenators)

Referenced Standards

GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods GB/T 14437-1997 Single sampling procedures and tables by attributes for product quality audit YY/T 0313-1998 Package,lable,transport and storage for medical polymer products 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 2828.1-2012 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process

Adopt standards

ISO 7199:1996

Related Standards

GB 12264-1990 Replaced

GB 12264-1990 Artificial heart-lung machine Silicon rubber pump tube

Publish Date: 1990-01-08

GB 12279-1990 Replaced

GB 12279-1990 Cardiac valve prostheses general technical specification

Publish Date: 1990-03-26

GB 12417-1990 Replaced

GB 12417-1990 The general technological conditions of surgical metal implant

Publish Date: 1990-07-17

GB/T 13461-1992 Replaced

GB/T 13461-1992 Synthetic resin blow knee prostheses

Publish Date: 1992-06-01

GB/T 14191-1993 Replaced

GB/T 14191-1993 Terminology for prosthetics and orthotics

Publish Date: 1993-02-25

GB 14722-1993 Replaced

GB 14722-1993 Endoskeletal above knee prosthesis

Publish Date: 1993-12-04