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1. YYT 1244-2014- Purified water for in vitro diagnostic reagents - English version

YY/T 1244—2014 Pharmaceutical Industry Standard of the People"s Republic of China: Purified Water for In Vitro Diagnostic Reagents1. ScopeThis standard specifies the terms and definitions, requirements, and test methods for purified water used in in vitro diagnostic (IVD) reagents. It applies to:Production of IVD reagents.Preparation of general reagents for medical laboratories.Cleaning of laboratory apparatus and devices.Note: Special requirements for reagent production (e.g., granules in blood count reagents, enzyme inhibitors in molecular biology reagents) must refer to relevant standards or be formulated separately.2. Normative ReferencesChinese Pharmacopoeia (2010 Edition, Volume II): Essential for microbial limit tests, total organic carbon (TOC) determination, and oxidizable substance tests.GB/T 1.1-2009: Regulations for drafting standards.ISO 3696:1987: Analytical laboratory water specifications (referenced for general water quality principles).3. Terms and DefinitionsPurified Water: Water without additives, produced from drinking water via distillation, ion exchange, reverse osmosis, or other suitable methods.4. Requirements4.1 Physical CharacteristicsAppearance: Clear, colorless liquid.4.2 ConductivityLimit: ≤ 0.1 mS/m (25 °C).Note: Conductivity reflects ionic contamination; 1 mS/m = 10 μS/cm.4.3 Microbial LimitsTotal Viable Count: ≤ 50 CFU/mL (tested via membrane filtration per Chinese Pharmacopoeia).4.4 Total Organic Carbon (TOC)Limit: ≤ 500 μg/L (tested per Chinese Pharmacopoeia Annex VIII R).4.5 Readily Oxidizable SubstancesTest Method: Boil 100 mL water with 10 mL dilute sulfuric acid (10%) and 0.10 mL potassi

um permanganate (0.02 mol/L) for 10 minutes; pink color must disappear completely.Note: This is an alternative to TOC testing (choose one method).5. Test Methods5.1 AppearanceProcedure: Visual inspection under normal light.Compliance: Must meet 4.1 (clear, colorless).5.2 ConductivityProcedure: Use a conductivity meter with automatic temperature compensation. If unavailable, adjust water temperature to 25 °C ± 1° C via a heat exchanger and convert readings.Compliance: Must meet 4.2 (≤ 0.1 mS/m).5.3 Microbial LimitsProcedure: Membrane filtration method per Chinese Pharmacopoeia Annex XI J.Compliance: Must meet 4.3 (≤ 50 CFU/mL).5.4 Total Organic Carbon (TOC)Procedure: Follow Chinese Pharmacopoeia Annex VIII R (pharmaceutical water method).Compliance: Must meet 4.4 (≤ 500 μg/L).5.5 Readily Oxidizable SubstancesProcedure: Follow Chinese Pharmacopoeia method for purified water oxidizability.Compliance: Pink color must disappear (meets 4.5).6. Additional NotesPatent Disclaimer: The standard does not identify patent rights; users are responsible for compliance.Jurisdiction: Under the National Technical Committee 136 (SAC/TC 136).Drafting Units: Beijing Institute of Medical Device Testing, Beckman Coulter, BioSino, DaAn Gene, and National Institutes for Food and Drug Control.ReferencesGB/T 6682-2008: Analytical laboratory water specifications.Chinese Pharmacopoeia (2010, Volume II).CLSI C3-A4 (2006): Clinical laboratory reagent water guidelines.ISO 3696:1987: Analytical water standards.This standard ensures purified water quality for IVD reagents, aligning with international principles while addressing specific needs of medical diagnostics.

2. Kneeling for Heat Energy and Power Engineering Professional English Vocabular

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