YY 0645-2018Continuous blood purification equipment (English PDF)

Foreword

The full technical content of this standard is mandatory.

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

This standard replaces YY 0645-2008 "continuous blood purification equipment", compared with YY 0645-2008, the main technical changes are as follows.

--- Further clarified the scope of application of the standard;

--- Normative references added YY 0709 and YY 0054-2010;

--- Redefine the terms of dehydration and equipment liquid balance error to make the definition more accurate;

--- Modified the description of the classification and marking;

--- Appropriate adjustments to the restrictions on normal working conditions;

---Modified blood pump flow accuracy, air entry protection system requirements and test methods;

---Modified dialysate pump flow, replacement fluid pump flow, equipment dehydration error alarm, transmembrane pressure protection system, network power supply interruption, The expression of air entering the protection system requirements;

--- Fixed the requirements and test methods for heparin pumps;

--- Increased blood leakage protection system, weighing scale, prevention or prevention of replacement fluid bag/dialysate bag evacuation requirements and test methods;

--- Added the requirement of YY 0709 in the security requirements;

--- Revised the requirements for signs, instructions, packaging, transportation and storage.

1 Scope

This standard specifies the terms and definitions, classification and marking, requirements, test methods, signs, instructions for use of continuous blood purification equipment. And packaging, transportation, storage.

This standard applies to continuous blood purification equipment (hereinafter referred to as equipment). The device does not have a replacement fluid or dialysate preparation function, and It can be used for blood purification treatment such as hemofiltration for 24 hours or more. This standard does not apply to.

---Water treatment device;

---Peritoneal dialysis equipment;

--- Equipment with only blood perfusion mode;

--- Equipment with only plasma therapy mode;

---hemodialysis equipment;

--- Other equipment with replacement fluid or dialysate preparation function.

2 Normative references

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

GB/T 191 packaging storage and transportation pictorial signs (GB/T 191-2008, ISO 780:1997, MOD)

GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1:1988, IDT)

GB 9706.2 Medical electrical equipment - Part 2-16. Safety specific to hemodialysis, hemodiafiltration and hemofiltration equipment Seeking (GB 9706.2-2003, IEC 60601-2-16.:1998, IDT)

GB/T 9969-2008 General instructions for the use of industrial products

GB/T 13074 blood purification terminology

GB/T 14710-2009 Environmental requirements and test methods for medical appliances

YY/T 0466.1 Medical devices for use in medical devices - Labels, markings and information provided - Part 1. General requirements (YY/T 0466.1-2016, ISO 15223-1:2012, IDT)

YY 0054-2010 Hemodialysis equipment

YY 0709 Medical electrical equipment - Part 1-8. Safety general requirements Parallel standard. General requirements, medical electrical equipment and medical Testing and guidance for alarm systems in electrical systems (YY 0709-2009, IEC 60601-1-8:2003, IDT)

3 Terms and definitions

The following terms and definitions as defined in GB 9706.2 and GB/T 13074 apply to this document.