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JJF 2088-2023 English PDF

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JJF 2088-2023: Calibration Specification for Temperature, Pressure and Time Parameters of Large Steam Sterilizers
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JJF 2088-2023English449 Add to Cart 4 days [Need to translate] Calibration Specification for Temperature, Pressure and Time Parameters of Large Steam Sterilizers Valid JJF 2088-2023

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Basic data

Standard ID JJF 2088-2023 (JJF2088-2023)
Description (Translated English) Calibration Specification for Temperature, Pressure and Time Parameters of Large Steam Sterilizers
Sector / Industry Metrology & Measurement Industry Standard
Word Count Estimation 22,248
Date of Issue 2023-10-12
Date of Implementation 2024-04-12
Issuing agency(ies) State Administration for Market Regulation

JJF 2088-2023: Calibration Specification for Temperature, Pressure and Time Parameters of Large Steam Sterilizers


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
National Metrology Technical Specifications of the People's Republic of China Large steam sterilizer temperature, pressure, Time parameter calibration specifications Released on 2023-10-12 Implemented on 2024-04-12 Released by the State Administration for Market Regulation Large steam sterilizer temperature, Pressure and time parameter calibration specifications Responsible unit: National Thermometry Technical Committee Main drafting unit: China Institute of Metrology Yunnan Provincial Institute of Metrology and Testing Technology Xinjiang Uygur Autonomous Region Metrology and Testing Research Institute Unit participating in the drafting: Peking Union Medical College Hospital Yunnan Provincial Geriatric Hospital Jilin Provincial Institute of Metrology Beijing Lindian Weiye Electronic Technology Co:, Ltd: The National Thermometry Technical Committee is entrusted with the interpretation of this specification: The main drafters of this specification: Jin Zhijun (China Institute of Metrology) Xu Shu (Yunnan Provincial Institute of Metrology and Testing Technology) Chen Wuqing (Xinjiang Uygur Autonomous Region Metrology Research Institute) Participating drafters: Zhang Qing (Peking Union Medical College Hospital) Wang Xu (Yunnan Geriatric Hospital) Sun Junfeng (Jilin Institute of Metrology) Xue Cheng (Beijing Lindian Weiye Electronic Technology Co:, Ltd:)

Table of contents

Introduction(Ⅱ) 1 Scope(1) 2 Cited documents(1) 3 Terms and Definitions(1) 4 Overview(2) 5 Measuring characteristics(3) 6 Calibration conditions(4) 6:1 Environmental conditions(4) 6:2 Load conditions(4) 6:3 Measurement standards and other equipment(4) 7 Calibration items and calibration methods (5) 7:1 Calibration items(5) 7:2 Appearance inspection(5) 7:3 Calibration method(5) 7:4 Data processing(6) 8 Calibration result expression(7) 9 Recalibration time interval(8) Appendix A Reference format for recording calibration results of large steam sterilizers (9) Appendix B Large steam sterilizer calibration certificate inner page reference format (11) Appendix C Example of uncertainty assessment of measurement results of large steam sterilizer (12) Appendix D Standard Test Package (16)

Introduction

This specification is based on JJF 1071-2010 "Rules for Preparing National Metrology Calibration Specifications" and JJF 1001-2011 "General Use Measurement Terms and Definitions" and JJF 1059:1-2012 "Evaluation and Expression of Measurement Uncertainty" as the basic series of regulations Fan to write: This specification adopts the relevant techniques of GB 8599-2008 "Technical Requirements for Large Steam Sterilizers with Automatic Control" terminology, definitions and some technical content: This specification includes measurement requirements and specific calibration for physical parameters such as temperature, pressure, and time of large steam sterilizers: quasi-project: Metering performance mainly includes sterilization temperature range, temperature uniformity, sterilization pressure, maintenance time, and equilibrium time: Specific requirements for waiting times: This specification is released for the first time: Large steam sterilizer temperature, pressure, Time parameter calibration specifications

1 Scope

This specification is applicable to steam sterilizer equipment that can be loaded with one or more sterilization units and has a volume greater than 60L: For calibration of temperature, pressure and time parameters, other similar equipment can also be calibrated with reference to this specification:

2 cited documents

This specification references the following documents: JJF 1101-2019 Specification for calibration of temperature and humidity parameters of environmental test equipment JJF 1308-2011 Calibration specifications for thermometers in medical thermal sterilization equipment GB 8599-2008 Technical requirements for large steam sterilizers, automatic control type GB/T:19971-2015 Terminology for sterilization of medical and healthcare products GB/T:19974-2018 Characteristics of sterilization factors for medical and health care products and sterilization process of medical devices General requirements for development, validation and routine controls WS310:3-2016 Hospital Disinfection Supply Center Part 3: Cleaning, Disinfection and Sterilization Effect Monitoring Standard For dated references, only the dated version applies to this specification; for undated references, only the dated edition applies: The latest version (including all modification orders) shall apply to this specification:

3 Terms and definitions

The following terms and definitions defined in GB/T:19971-2015, EN285:2015 and GB 8599-2008 applicable to this specification: 3:1 Sterilization A validated process that renders a product free of viable microorganisms: Note: During the sterilization process, the inactivation characteristics of microorganisms are expressed by an exponential function: The presence of viable microorganisms on any individual piece of product is available Probability representation: The probability can be reduced to a very low level, but it cannot be reduced to zero: [Source: GB/T:19971-2015,2:47] The lowest temperature based on which sterilization effectiveness is evaluated: [Source: EN285:2015,3:33] The location of the temperature sensor for measurement near the drain outlet in the sterilization chamber: 3:4 Equilibration time equilibrium time The time required from the time when the reference measuring point reaches the sterilization temperature to when all parts of the load reach the sterilization temperature: [Source:GB 8599-2008,3:6]

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