GB 8662-1988
Replaced
YY/T 1270-2015
Active
Industry standards-Medicine
YY/T 1270-2015 Cardiopulmonary bypass systems—Blood lines connector
YY/T 1270-2015 Cardiopulmonary bypass systems—Blood lines connector
Basic Information
Standard Code:
YY/T 1270-2015
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Surgical instruments and materials
Publish Date:
2015-03-02
Implement Date:
2016-01-01
Pages:
8 pages
Scope
This standard specifies the requirements, test methods, marking and labeling, packaging, transportation, storage, and user manuals for blood path connectors (connectors) used in cardiopulmonary bypass systems.
This standard applies to blood path connectors (connectors) used in cardiopulmonary bypass systems (hereinafter referred to as connectors), which are used in extracorporeal circulation surgery to transport blood through the blood path, for observation, and for connection purposes.
Development Information
Referenced Standards
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB 19335-2003 Blood flow products for single use—General specification
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
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 6543-1986 Corrugated box
GB/T 6543-2008 Single and double corrugated boxes for transport packages
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
GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test 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
GB 18279-2000 Medical devices—Validation and routine control of ethylene oxide sterilization
GB 18279-2023 Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB/T 18279.2-2015 Sterilization of health care products—Part 2:Guidance on the application of GB 18279.1
GB 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization
GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB 18280.2-2015 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose
GB/T 18280.3-2015 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects
GB/T 19633-2005 Packaging for terminally sterilized medical devices
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems
GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes
GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes
YY/T 0313-1998 Package,lable,transport and storage for medical polymer products
YY/T 0313-2014 Medical polymer products—Requirement for package and information supplied by manufacturer
GB/T 6543-2025 Single and double corrugated boxes for transport packages
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
GB/T 18280.2-2025 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose
GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices
GB/T 18280.3-2025 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects of development,validation and routine control
Related Standards
GB 2766-1995
Replaced
GB 2766-1995 Haemostatic forceps with box joint—General specifications
GB/T 10160-1995
Abolished
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps
GB 9706.4-1999
Replaced
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
YY 0464-2003
Replaced
YY 0464-2003 Single use hemoperfutor
YY 0054-2003
Replaced