RB/T 034-2020 in English

VALID

Guidance on verification and validation of microbiological testing methods

Issued on:2020-08-26
Implemented on:2020-12-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $240.00
$233.00

Standard No:	RB/T 034-2020
Document status:	VALID
Title in English:	Guidance on verification and validation of microbiological testing methods
Title in Chinese:	测量设备校准周期的确定和调整方法指南
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2020-08-26
Implemented on:	2020-12-01
Related Topics:	Equipment calibration period cycle RB∕T rb/t 197 rb/t 195 rb/t 190 rb/t 115 rb/t 205 rb/t 204 equipment cycle rb/t rab rb Institutional adjustment rb/t 116 equipment calibration rb/t+ Measuring equipment in Institutional adjustment period rb /t rb/t 119 rb t equipment calibration Measurement preparation holiday adjustment Measuring Equipment Calibration Standard material calibration cycle Measuring Equipment Calibration RB T 199 Device Validation Guide Mid-term adjustment 13th five-year mid-term adjustment rb t 119 rb /t 120 rb/t 120 holiday adjustment Equipment Calibration Equipment Calibration definition rb/t 199 rb period rb/t 104 rb t 197 Calibration of measuring equipment Equipment Calibration and Equipment Verification rb/t 191 RB RB/T rb/t 188 Oxygen and explosion detector calibration cycle Balance self-calibration cycle measuring equipment Three methods of cell cycle determination Viscometer calibration cycle The latest version of the principles and methods of calibration cycle of measuring instruments Calibration method for determining the accurate content of a substance Principles and methods for determining the calibration cycle of measuring instruments Spectrometer adjustment method National measurement standard verification and calibration cycle How to measure the cell cycle Range/zero adjustment method and wiring method How to adjust the wire straightener Instrument calibration cycle Adjustment methods to prevent calibration failure Cell cycle determination method Spectrometer adjustment method rb 043 2020 rb t 14 rb/t 089 rb/t028-2020 rb/t063-2020

Introduction

Analysis of the core content of the standard

Method type	Applicable scenarios	Adjustment coefficient	Data requirements
Simple reaction adjustment method	Stable performance equipment	α=0.11, β=0.61	≥3 consecutive calibration data
Incremental reaction adjustment method	Mathematical modeling equipment required	Dynamic calculation	Historical calibration trend
Periodic verification method	Standard equipment for verification	-	Verification records ≥ 6 times

Key technical points

Initial cycle determination factors

According to the requirements of Chapter 5 of the standard, the initial cycle of new equipment should be comprehensively evaluated: manufacturer recommendations, frequency of use, environmental factors and other 12 key indicators, among which 3 equal blocks and other metrological standards need to pay special attention to the accumulation of historical data.

Cycle adjustment risk control

Clause 6.1.2 of the standard clearly requires the establishment of a double threshold mechanism: when the error exceeds MPE80%, the cycle review is triggered, and when it exceeds 100%, the cycle must be shortened immediately and the previous test data must be traced back.

Implementation suggestions

Establish a hierarchical management system for equipment, and implement shorter monitoring cycles for key equipment such as M1-level weights
Develop an intelligent analysis system for calibration data to automatically calculate the reaction adjustment coefficient
Periodic verification should cover the key points of the full range of equipment to avoid the risk of "false negatives"

Analysis of standard evolution

This standard implements the concept of "risk-based calibration cycle" in ISO/IEC 17025:2017 for the first time. Compared with the old version, it adds periodic verification results and equipment maintenance records as the statutory basis for adjustment, reflecting the modern metrological concept of "data-driven decision-making".

More samples: DL/T 5154-2012 GB 18306-2015 YD/T 3934-2021

Sample only — not a preview of RB/T 034-2020

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