This standard specifies the terms and definitions, requirements and test methods of purified water for in vitro diagnostic reagents.
Purified water for in vitro diagnostic reagents may be used for production of in vitro diagnostic reagents, preparation of general reagents in medical laboratories, cleaning of instruments and apparatus, etc.
Relevant standards may be referred to or special requirements (such as the special requirements of particles in blood cell counting reagents; special requirements of DNase, RNase and protease in molecular biological reagents, etc.) may be prepared since there are special requirements for reagent production.
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.
Pharmacopoeia of the People’s Republic of China (2010 Edition, Volume II)
3 Terms and definitions
For the purposes of this document, the following term and definition apply.
3.1
purified water
additive-free water prepared by distillation, ion exchange, reverse osmosis or other suitable methods
4 Requirements
4.1 Characteristics
The product shall be a kind of clear and colorless liquid.
4.2 Conductivity
The conductivity (25℃) shall not be greater than 0.1mS/m.
