YY/T 1244-2014Purified water for in vitro diagnostic reagents (English PDF)

体外诊断试剂用水

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 17, 2014

Implementation date

July 1, 2015

Scope

YY/T 1244-2014 is the English-translated version of 体外诊断试剂用水.

YY/T 1244 specifies the purified water used in in vitro diagnostic reagents. Water is the largest single ingredient in most diagnostic reagents and the one most likely to carry what nobody intended: ions that shift a pH, organics that quench a signal, nucleases that destroy a target, or bacteria whose growth changes a reagent over its shelf life. Grading water by conductivity, organic carbon, microbial count and the other parameters the standard sets is what makes reagent manufacture reproducible. It sits with YY/T 1239 on prepared agar plates among the Chinese standards covering the inputs to diagnostics rather than the finished tests. For an IVD manufacturer producing in or supplying to China, this is the specification the water system is qualified against.

Document preview — YY/T 1244-2014

National Standard of the People's Republic of China

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

Foreword

Purified water for in vitro diagnostic reagents

1 Scope This Standard specifies terms and definitions, requirements, and test methods of purified water in-vitro diagnostic reagents. Purified water for in-vitro diagnostic reagents can be used for in-vitro diagnostic reagents' production, general reagent preparation in medical laboratory, instrument and equipment cleaning etc. If there are special requirements for reagents production, REFER to the relevant standards or FORMULATE a special requirement (such as the special requirements for particle by blood cell counting reagents; the special requirements for DNA enzymes, RNA enzymes, and protease by molecular biology reagents). #

2 Normative references The provisions in following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Standard. Pharmacopoeia of the People's Republic of China 2010 Edition (Volume II) #

3 Terms and definitions The following terms and definitions apply to this document.

3.1 purified water This product is the water obtained from drinking water by distillation method, ion-exchange method, reverse-osmosis method or other suitable methods, without any additives. #

4 Requirements

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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