YY 0485-2020Single-use cardioplegia delivery system (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces YY 0485-2011 "Disposable Cardioplegia Perfusion Device", compared with YY 0485-2011, except for editorial The main technical changes are as follows.

---Added the requirements of pump pipe performance (see 4.2.1);

---Modified the requirements for the flow rate of the perfusion device (see 4.2.1.1, 4.2.6 of the 2011 edition);

---Modified the requirements of variable temperature performance (see 4.2.3, 4.2.3 of the 2011 edition);

---Added requirements for temperature adaptability (see 4.2.7);

---Added the requirements for corrosion resistance (see 4.4);

---Modified the pyrogen-free requirements and test methods (see 4.5.2, 5.5.2, 4.4.3 and 5.4.3 of the 2011 edition);

---Modified the test method of tightness (see 5.2.4, 5.2.4 of the 2011 edition);

---Inductively coupled plasma mass spectrometry has been added (see 5.3.3);

--- The logo, label, instruction manual and packaging, transportation and storage have been deleted (see Chapter 6 and Chapter 7 of the 2011 edition).

Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.

1 Scope

This standard specifies the structure, classification, requirements and test methods of disposable cardioplegia perfusion devices.

This standard applies to single-use cardioplegia perfusion devices (hereinafter referred to as perfusion devices). Perfusion device for cardiopulmonary bypass open heart surgery Used for cardioplegia perfusion.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document.

GB/T 1962.1 Syringes, injection needles and other medical devices 6% (Luer) tapered joints Part 1: General requirements

GB/T 1962.2 Syringes, injection needles and other medical devices 6% (Luer) tapered joints Part 2: Locking joints

GB/T 14233.1-2008 Medical transfusion, blood transfusion, injection equipment inspection methods Part 1: Chemical analysis methods

GB/T 16886.1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in the Process of Risk Management

GB 18278.1 Hygrothermal Sterilization of Medical and Healthcare Products Part 1: Development, Validation and Routine Control Requirements for the Sterilization Process of Medical Devices

GB 18279.1 Sterilization of medical and health care products, ethylene oxide Part 1: Requirements for the development, validation and routine control of the sterilization process of medical devices

GB 18280.1 Sterilization radiation of medical and health care products Part 1: Requirements for the development, validation and routine control of the sterilization process of medical devices

GB 19335-2003 General technical requirements for single-use blood circuit products

YY/T 0149-2006 Stainless steel medical equipment corrosion resistance test method

YY/T 0681.1 Sterile medical device packaging test method Part 1: Guide to accelerated aging test Pharmacopoeia of the People's Republic of China

3 Structure and classification

4 Requirements