1 Scope
This part of YY 0793 specifies the terms and definitions, requirements, test methods, inspection rules, marking and instructions for use, and packaging, transportation and storage of water treatment equipments for single-bed haemodialysis applications and related therapies [hereinafter referred to as equipment(s)].
This part is applicable to water treatment equipments for the preparation of water for single-bed haemodialysis and related therapies, and not to those for the preparation of water for multi-beds haemodialysis and related therapies. This part covers within its application scope water used for:
a) the preparation of dialysis concentrates;
b) the preparation of dialysis fluid;
c) the reprocessing of dialysers for multiple uses.
Included within the scope of this part are all devices, piping and fittings between the point at which municipal potable water is delivered to the equipments and the point of use of the water treated by the equipments. Excluded from the scope of this part are:
a) concentrate supply systems;
b) dialysis fluid regeneration systems;
c) dialysis concentrates;
d) haemodiafiltration systems;
e) haemofiltration systems;
f) systems that process dialysers for multiple uses, and peritoneal dialysis systems.
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2 Normative references
The following referenced documents are indispensable for the application 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/T 191 Packaging - Pictorial marking for handling of goods
GB 5749 Standards for drinking water quality
GB/T 5750.2 Standard examination methods for drinking water - Collection and preservation of water samples
GB/T 5750.10 Standard examination methods for drinking water - Disinfection by-products parameters
GB/T 5750.11 Standard examination methods for drinking water - Disinfectants parameters
GB 9706.1 Medical electrical equipment - Part 1: General requirements for safety
GB/T 9969 General principles for preparation of instructions for use of industrial products
GB/T 13074 Terms of blood purification
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
GB/T 17219 Standard for safety evaluation of equipment and protective materials in drinking water system
GB 19104 Peracetic acid solution
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: general requirements
YY 0572 Water for haemodialysis and related therapies
YY/T 0709 Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
YY 0793.1 Technical requirements for water treatment equipments for haemodialysis applications and related therapies - Part 1: For multi-beds haemodialysis
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 13074 and YY 0793.1 and the following apply.
Foreword II
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Inspection rules
7 Marking and instructions for use
8 Packaging, transportation and storage
