1 Scope
This Standard specifies terms and definitions, classification and basic parameters, requirements, test methods and inspection rules, marking, operating instructions as well as packaging, transportation and storage of the hemodialysis equipment.
This Standard is applicable to the hemodialysis equipment for automatically preparation of dialyzing fluid (hereafter referred to as "equipment").
This Standard is not applicable to:
- Water treatment equipment for hemodialysis;
- Peritoneal dialysis equipment;
- Blood perfusion, plasma exchange and plasma adsorption equipment;
- Continuous blood purification equipment.
2 Normative References
The following documents contain provisions which, through reference in this text, constitute provisions of this Standard. For dated references, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to study whether the latest edition of these documents applies. For undated references, the latest edition of the normative documents applies.
GB/T 191 Packaging - Pictorial Marking for Handling of Goods (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+A1+A2, IDT)
GB 9706.2 Medical Electrical Equipment - Part 2-16: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment (GB 9706.2-2003, IEC 60601-2-16: 1998, IDT)
GB/T 9969 General Principles for Preparation of Instructions for Use of Industrial Products
GB/T 13074 Terms of Blood Purification
GB/T 14710 The Environmental Requirements and Test Methods for Medical Electrical Equipment
YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels, Marking and Information to be Supplied (YY/T 0466.1-2009, ISO 15223: 2000, IDT)
YY 0598 Concentrates for Haemodialysis and Related Therapies (YY 0598-2006, ISO 13958: 2002, MOD)
Pharmacopoeia of People's Republic of China (Edition 2005)
3 Terms and Definitions
Foreword I
1 Scope
2 Normative References
3 Terms and Definitions
4 Classification and Basic Parameters
5 Requirements
6 Test Methods
7 Inspection Rule
8 Marking, Operating Instructions, Packaging, Transportation and Storage
Appendix A (Normative) Test in Bubble Detection Mode
