GB 12263-2017 Active National standards force_standard

GB 12263-2017 Cardiopulmonary bypass systems—Water heating/cooling system

GB 12263-2017 Cardiopulmonary bypass systems—Water heating/cooling system

Publish Date: 2017-12-29 Implement Date: 2019-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 12263-2017

Standard Type: National standards

Standard Status: Active

is_force_gb: yes

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

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2017-12-29

Implement Date: 2019-07-01

Pages: 8 pages

Scope

This standard specifies the terms and definitions, requirements, test methods, marking, instructions, packaging, transportation, and storage of heat exchange water tanks for cardiopulmonary bypass systems.
This standard applies to heat exchange water tanks for cardiopulmonary bypass systems (hereinafter referred to as "water tanks"), which are used to provide heating water, cooling water, and raw water for the heat exchanger in the extracorporeal circulation blood heat exchange system, and are intended for medical units to regulate temperature during extracorporeal circulation perfusion procedures.

Development Information

Word Count: 14 Thousand words Pages: 8 pages

Replace the following standards

GB 12263-2005 Artificial heart-lung machine—Water heating/cooling system

Referenced Standards

GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 9969-2008 General principles for preparation of instructions for use of industrial products GB 9969.1-1998 General principles for preparation of instructions for use of industrial products YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements YY/T 1145-2003 Terms of artificial heart-Lung machine YY/T 1145-2014 Terms of cardiopulmonary bypass systems 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