YY 1048-2007 Replaced Industry standards-Medicine

YY 1048-2007 Artificial heart-lung machine—Extracorporeal blood circuit

YY 1048-2007 Artificial heart-lung machine—Extracorporeal blood circuit

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 1048-2007

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: 9 pages

Scope

This standard specifies the classification and naming, requirements, test methods, inspection rules, marking, packaging, transportation, and storage of extracorporeal circulation pipes used in artificial heart-lung machines (hereinafter referred to as pipes). This standard applies to extracorporeal circulation pipes used in artificial heart-lung machines and the auxiliary pipelines integrated with them. This product is intended for use in cardiovascular and related surgeries as a blood channel and channel connection during extracorporeal circulation, and is intended for single-use only.

Development Information

Word Count: 15 Thousand words Pages: 9 pages

Replace the following standards

YY 91048-1999

Superseded by the following standards

YY 1048-2016 Cardiopulmonary bypass systems—Extracorporeal blood circuit

Referenced Standards

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 YY/T 0313-1998 Package,lable,transport and storage for medical polymer products GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 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 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 9969.1-1998 General principles for preparation of instructions for use of industrial products 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 GB/T 191-2025 Graphical symbols marking for handling and storage of packages

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