YY 0948-2025 Pending Industry standards-Medicine

YY 0948-2025 Cardiopulmonary bypass systems—Arteriovenous cannula for single use

YY 0948-2025 Cardiopulmonary bypass systems—Arteriovenous cannula for single use

Publish Date: 2025-06-18 Implement Date: 2028-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0948-2025

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

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

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2025-06-18

Implement Date: 2028-07-01

Pages: 28 pages

Scope

This document specifies the requirements for single-use sterile arterial-venous catheters used for draining or perfusing blood during the implementation of cardiopulmonary bypass, extracorporeal lung assistance, left or right heart bypass, cardiopulmonary support, extracorporeal life support, extracorporeal carbon dioxide removal, and other extracorporeal circulation techniques, and describes the corresponding test methods.
This document applies to single-use sterile arterial-venous catheters used for draining or perfusing blood.
This document does not apply to:
——Guiding devices (such as guidewires) described in YY 0450.1—2020;
——Isolated organ perfusion catheters;
——Vascular intravascular catheters described in YY 0285.3—2017.

Development Information

Word Count: 35 Thousand words Pages: 28 pages

Replace the following standards

YY 0948-2015 Cardiopulmonary bypass systems—Arteriovenous cannula for single use

Referenced Standards

GB/T 1962.1-2015 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment—Part 1:General requirement 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 14233.1-2022 Test methods for infusion,transfusion,injection equipments 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 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 YY/T 0149-2006 Medical instruments of stainless steel—Test methods of corrosion resistance YY/T 0586-2016 Medical polymer products-Test methods of radiopacity YY/T 0681.1-2018 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging YY/T 1556-2017 Test methods for particle contamination of infusion,transfusion and injection equipments for medical use 中华人民共和国药典　2020年版

Adopt standards

ISO 18193:2021(第三版)

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