Standard No.:	YY/T 1244-2014
English Name:	Purified water for in vitro diagnostic reagents
Chinese Name:	体外诊断试剂用纯化水
Chinese Classification:	C44    Medical laboratory equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
Issued by:	China Food and Drug Adminstration
Issued on:	2014-06-17
Implemented on:	2015-7-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	3500 words
Price(USD):	80.0
Delivery:	via email in 1 business day

Purified water for in vitro diagnostic reagents 1 Scope 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.

Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Requirements 5 Test methods Bibliography