YY/T 1270-2015Cardiopulmonary bypass systems—Blood lines connector (English PDF)
心肺转流系统 血路连接器（接头）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 2, 2015
Implementation date
January 1, 2016
Scope
YY/T 1270-2015 is the English-translated version of 心肺转流系统 血路连接器（接头）.
YY/T 1270-2015 is the Chinese standard "Cardiopulmonary bypass systems—Blood lines connector". Its scope clause reads: This standard specifies the connector trail cardiopulmonary bypass system used (joint) requirements, test methods, marking and labeling, packaging, transportation, Storage and operation manual.
This standard applies to the use of cardiopulmonary bypass system survive connector (connector) (hereinafter referred to as joints), joint for cardiopulmonary bypass surgery Bypass channel system pumping blood trail, observation and connections. Its clauses include classification and marking.
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Document preview — YY/T 1270-2015
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C 45
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Classification and Marking
1 Scope
This standard specifies the connector trail cardiopulmonary bypass system used (joint) requirements, test methods, marking and labeling, packaging, transportation,
Storage and operation manual.
This standard applies to the use of cardiopulmonary bypass system survive connector (connector) (hereinafter referred to as joints), joint for cardiopulmonary bypass surgery
Bypass channel system pumping blood trail, observation and connections.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
GB/T 1962.2 syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 2. Lock fittings
GB/T 6543 transport packaging corrugated box with a single and double corrugated boxes
GB/T 9969 General Instructions industrial products
GB/T 14233.1-2008 Infusion, transfusion, injection equipment - Part 1. Chemical analysis
GB/T 14233.2 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test
GB 18279 ethylene oxide sterilization of medical devices - Validation and routine control
GB 18280 Sterilization of health care products Requirements for validation and routine control of radiation sterilization
GB 19335-2003 disposable products general technical conditions to survive
GB/T 19633 Packaging for terminally sterilized medical devices
YY/T 0313 Medical Polymer Co., packaging, labeling, transportation and storage
3 Classification and Marking
3.1 divided by channel
straight connectors, tees, side hole straight through joints, as shown in Figure 1.
3.2
specification by fitting match to survive passage is generally divided into. 4.8mm (3/16 "), 6.3mm (1/4"), 9.5mm (3/8 "), 12.7mm (1/2 ") and other four.
Note. Other specifications prescribed by the manufacturers themselves.
3.3 Specifications marked
Straight AB, tees ABC, side AB and other pass-through hole.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB/T 1962.2Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- GB/T 6543Single and double corrugated boxes for transport packages
- GB/T 9969General principles for preparation of instructions for use of industrial products
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
GB 18280 · GB 19335-2003 · GB/T 19633
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