GB/T 42218-2022Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer (English PDF)
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Issued by
State Administration for Market Regulation, China National Standardization Administration
Level / Type
National · Recommended
Issue date
December 30, 2022
Implementation date
July 1, 2023
Scope
GB/T 42218-2022 (Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer) is available as an English-translated PDF.
GB/T 42218-2022 is the Chinese standard "Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer".
Its scope clause reads: This document describes the process by which manufacturers of in vitro diagnostic medical devices validate quality control procedures recommended to users.
Quality Control Procedures The purpose of the test is to provide the user with assurance that the performance of the device is consistent with its intended use and the manufacturer's declaration.
This document applies to all in vitro diagnostic medical devices. Its clauses include terms and definitions.
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Document preview — GB/T 42218-2022
National Standard of the People's Republic of China
- ICS
- 11.100.10
- Classification
- C 30
Issued by: State Administration for Market Regulation, China National Standardization Administration
Contents
- Preface
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Quality Control Procedures
- 5 Validation of quality control procedures
- 6 Advice to users
1 Scope
This document describes the process by which manufacturers of in vitro diagnostic medical devices validate quality control procedures recommended to users. Quality Control Procedures
The purpose of the test is to provide the user with assurance that the performance of the device is consistent with its intended use and the manufacturer's declaration.
This document applies to all in vitro diagnostic medical devices.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 29791.1 Information provided by manufacturers of in vitro diagnostic medical devices (labelling) Part 1.Terms, definitions and general requirements
Seek (GB/T 29791.1-2013, ISO 18113-1.2009, IDT)
ISO 13485 medical device quality management system for regulatory requirements (Medicaldevices-Qualitymanagement
Note. YY/T 0287-2017 Medical Device Quality Management System is used for regulatory requirements (ISO 13485.2016, IDT)
Note. Application of YY/T 0316-2016 Medical Device Risk Management to Medical Devices (ISO 14971.2007 Corrected Edition, IDT)
JJF1001 General Metrology Terms and Definitions
3 Terms and Definitions
GB/T 29791.1, ISO 13485, ISO 14971, JJF1001, ISO /IEC Guide 99 and the following terms and definitions apply used in this document.
3.1 Accuracyaccuracy
The degree of agreement between the measured value of a measurand and its true value.
[Source. JJF1001-2011,5.8]
3.2 bias
An estimate of the systematic measurement error.
[Source. GB/T 29791.1-2013, A.3.25] […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 29791.1In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements
- GB/T 29791.1-2013In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements
- YY/T 0287-2017Medical devices-Quality management systems- Requirements for regulatory purposes
- YY/T 0316-2016Medical devices-Application of risk management to medical devices
ISO 18113 · ISO 13485 · ISO 13485.2016 · ISO 14971.2007
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Related Standards
GB/T 29791.1-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements
YY/T 0287-2017 — Medical devices-Quality management systems- Requirements for regulatory purposes
YY/T 0316-2016 — Medical devices-Application of risk management to medical devices
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GB/T 42218-2022
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