YY 0054-2023 in English

Haemodialysis equipment

1 Scope

This document specifies the classification and requirements of haemodialysis equipment and describes the test methods.

This document is applicable to haemodialysis equipment with automatical preparation of dialysis fluid (hereinafter referred to as equipment).

This document is not applicable to:

——haemodialysis water treatment equipment;

——peritoneal dialysis equipment;

——hemoperfusion, plasma substitution and plasma adsorption equipment;

——continuous blood purification equipment;

——central delivery system;

——haemodialysis equipment with renewable dialysis fluid.

2 Normative references

The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

GB 9706.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.216 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
GB/T 14710 Environmental requirement and test methods for medical electrical equipment
YY 0598 Concentrates for haemodialysis and related therapies
YY 1272-2016 Dialysis fluid filter
YY 9706.108 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

3 Terms and definitions

For the purposes of this document, the terms and definitions given in GB 9706.216 and the following apply.

3.1
A0 value
time equivalent to the time measured in seconds during thermal disinfection at 80℃, calculated using Equation (1):

A0＝∑10[(T-80)/z]×Δt (1)

where,

A0——the value of A when z is 10℃;

T——the thermal disinfection maintenance temperature, ℃;

Δt——the selected time interval, specified by the manufacturer, s.

3.2
automatical preparation of dialysis fluid
process of preparing dialysis fluid that meets the clinical requirements, during which the ratio of haemodialysis concentrate to dialysis water is automatically controlled by equipment

3.3
online equipment
equipment capable of online hemofiltration therapy (online HF therapy) and/or online haemodiafiltration therapy (online HDF)

4 Classification

Equipment may be classified into haemodialysis type and haemodiafiltration type.

5 Requirements

5.1 Normal operating conditions of equipment

The following conditions shall be met for the normal operation of the equipment:

a) ambient temperature: 10~30℃ or as specified by the manufacturer;

Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
5.1 Normal operating conditions of equipment
5.2 Flow rate control
5.3 Dialysis fluid composition
5.4 Filtration-sterilization system
5.5 Dialysis fluid conductivity control and protection
5.6 Temperature control
5.7 Pressure monitoring
5.8 Flow rate, temperature and conductivity stability of dialysis fluid
5.9 Blood leak protective system
5.10 Prevention against air admission
5.11 pH measuring device
5.12 Grid power supply interruption
5.13 Degassing function
5.14 Liquid waste protection
5.15 Disinfection
5.16 Operating noise
5.17 Appearance and structure
5.18 Safety requirements
5.19 Environmental test
6 Test methods
6.1 Test conditions
6.2 Flow rate control test
6.3 Dialysis fluid composition test
6.4 Filtration-sterilization system test
6.5 Dialysis fluid conductivity control and protection test
6.6 Temperature control system test
6.7 Pressure monitoring test
6.8 Test of flow rate, temperature and conductivity stability of dialysis fluid
6.9 Blood leak protective system test
6.10 Prevention against air admission
6.11 pH measuring device test
6.12 Grid power supply interruption test
6.13 Degassing function test
6.14 Liquid waste protection test
6.15 Disinfection test
6.16 Operating noise test
6.17 Appearance and structure test
6.18 Test for safety requirements
6.19 Environmental test