Clinical laboratory medicine -
In vitro diagnostic medical devices -
Validation of user quality control procedures by the manufacturer
1 Scope
This standard describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims.
This standard applies to all in vitro diagnostic medical devices.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 29791.1 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (GB/T 29791.1-2013, ISO 18113-1:2009, IDT)
ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes
Note: YY/T 0287-2017 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016, IDT).
ISO 14971 Medical devices - Application of risk management to medical devices
Note: YY/T 0316-2016 Medical devices - Application of risk management to medical devices (ISO 14971:2007, corrected version, IDT)
JJF 1001 General terms in metrology and their definitions
ISO/IEC Guide 99 International vocabulary of metrology - Basic and general concepts and associated terms (VIM)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 29791.1, ISO 13485, ISO 14971, JJF 1001, ISO/IEC Guide 99 and the following apply.
3.1
accuracy
closeness of agreement between a measured value and its true value
[Source: JJF 1001-2011, 5.8]
3.2
bias
estimated value of system measurement error
[Source: GB/T 29791.1-2013, A.3.25]
3.3
control materials
QC materials
substances, materials or articles used by their manufacturers to verify the performance characteristics of an in vitro diagnostic medical device
Note: At present, control material is also referred to as "QC material" in China.
[Source: GB/T 29791.1-2013, 3.13]
3.4
control procedure
specifically described set of operations at the point of use, intended to monitor the performance of an IVD medical device and achieve the quality requirements
Note 1: Control procedure may be intended to monitor all or part of the in vitro diagnostic test procedure, from the collection of samples to reporting the test result.
Note 2: Adapted from ISO 15198:2004, Definition 3.5.
[Source: GB/T 29791.1-2013, 3.14]
3.5
examination
set of operations having the object of determining the value or characteristic of a property
Note 1: In some disciplines (e.g. microbiology), an examination is the overall activity of several experiments, observations or measurements.
Note 2: A laboratory examination intended to determine the value of a property is defined as quantitative examination; a laboratory examination intended to determine the characteristic of a property is defined as qualitative examination.
Note 3: In the clinical chemistry industry, a laboratory examination is referred to as an assay or test.
[Source: GB/T 29791.1-2013, 3.16]
3.6
information supplied by the manufacturer
labelling
written, printed or graphic matter attached to an IVD medical device or any of its containers or wrappers, or otherwise accompanying an IVD medical device, relating to the identification and use of the medical device, and providing a technical description, but excluding shipping documentation
Example: labels, instructions for use
Note 1: In IEC standard, the documents provided with a medical device are referred to as "accompanying documents", which contain important information for relevant parties and operators, especially safety-related information.
Note 2: The product catalogue and material safety data sheet are not regarded as labelling of an IVD medical device.
Note 3: Adapted from YY/T 0287-2003, Definition 3.6.
[Source: GB/T 29791.1-2013, 3.29]
3.7
instructions for use
information supplied by the manufacturer concerning the safe and proper use of an IVD medical device
Note 1: It includes the instructions provided by the manufacturer on the use, maintenance, troubleshooting and disposal of the IVD medical device, as well as warnings and precautions.
Note 2: Adapted from EN 376:2002, Definition 3.9 and EN 591:2001, Definition 3.3.
[Source: GB/T 29791.1-2013, 3.30]
3.8
intermediate measurement precision
intermediate precision
measurement precision under a set of measurement conditions, which include the same measurement procedure, the same location and repeated measurements on identical or similar test items for a long period of time, any may include other related conditions changed
Note 1: To practical extent, the changed and unchanged conditions should be specified, especially variables such as calibrators, reagent lot Nos, equipment systems, operators and environmental conditions.
Note 2: In the evaluation of an IVD medical device, the intermediate precision conditions generally selected represent the actual use conditions of the IVD medical device over a long period of time.
Note 3: Relevant statistical terms are given in ISO 5725-3.
Note 4: The intermediate precision may be expressed quantitatively by the dispersive characteristic terms of the result, e.g. standard deviation, variance and coefficient of variation.
Note 5: Adapted from ISO/IEC Guide 99:2007, Definitions 2.22 and 2.23.
[Source: GB/T 29791.1-2013, A.3.20]
3.9
manufacturer
natural or legal person who manufactures a medical device for intended use on his behalf with responsibility for the design and/or manufacture of the medical device, regardless of whether these operations are carried out by that person himself or on his behalf by another natural or legal person(s)
Note 1: The “natural or legal person” has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical device in the countries or jurisdictions where it is intended to be made available or sold, unless such responsibility is specifically imposed on another natural or legal person by the Regulatory Authority (RA) within that jurisdiction.
Note 2: The manufacturer's responsibilities are explained in other GHTF guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of corrective actions.
Note 3: The above mentioned "design and/or manufacture" may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, remanufacturing of a medical device, or combination of devices, possibly with other products, for medical purposes.
Note 4: If assembly or modification does not change the intended use of a medical device, and the medical device has been provided to an individual patient by another natural or legal person according to the instructions for use, any natural or legal person who assembles or modifies the medical device is not the manufacturer.
Note 5: Any natural or legal person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and makes it available for use under his own name should be considered the manufacturer of the modified medical device.
Note 6: An authorized representative, distributor or importer who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labeling, is not considered a manufacturer.
Note 7: To the extent that an accessory is subject to the regulatory requirements of a medical device, the natural or legal person responsible for the design and/or manufacture of that accessory is considered the manufacturer.
[Source: ISO 13485:2016, 3.10]
3.10
precision of measurement
closeness of agreement between the measurement indications and the measurements obtained from repeated measurements for the same or similar measured objects under the specified conditions
Note 1: The degree of precision is expressed numerically by the statistical measures of imprecision of measurements, such as standard deviation and coefficient of variation, that are inversely related to precision. Quantitative measures of precision depend on the stipulated conditions
Note 2: Precision of a given measurement procedure is subdivided according to the specified precision conditions. Particular sets of extreme conditions are termed repeatability and reproducibility.
[Source: JJF 1001-2011, 5.10, VIM, 2.15]
3.11
procedure
specified way to carry out an activity or a process
[Source: GB/T 19000-2016, 3.4.5]
3.12
risk analysis
systematic use of available information to identify hazards and to estimate the risk
[Source: ISO 14971:2019, 3.19]
3.13
sample
one or more representative parts taken from a population and intended to provide information on the population
[Source: GB/T 29791.1-2013, 3.64, modified]
3.14
measurement trueness
trueness
closeness of agreement between the average value obtained from infinite series of repeated measurements and a reference value
Note: Measurement trueness is not a quantity, and therefore it cannot be expressed numerically. The measure of closeness of agreement is given in ISO 5725-3.
[Source: GB/T 29791.1-2013, A.3.34, modified]
3.15
validation
confirmation that the specified requirements meet the intended use
Example: The procedure for measuring creatinine concentration in human serum can also be confirmed for the determination of creatinine in human urine.
Note: Validation in GB/T 19000-2016 3.8.13 is defined as: confirmation, through provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.
[Source: GB/T 29791.1-2013, 3.72]
3.16
verification
provision of objective evidence for a given item to confirm that specified requirements have been fulfilled
Example 1: Confirmation of the uniformity claimed for a given reference material in terms of its measurement value, and related measurement procedure and measured part, up to a mass of 10mg.
Example 2: Confirmation that the measuring system meets the performance characteristics or statutory requirements.
Example 3: Confirmation that the target measurement uncertainty can be fulfilled.
Note 1: A given item can be, for example, a process, measurement procedure, material, compound or measuring system.
Note 2: The specified requirements may be, for example, fulfillment of the manufacturer's statement or technical indicators.
Note 3: In legal metrology, verification is related to the inspection and labelling of a measuring instrument and/or the issuance of a verification certificate.
[Source: GB/T 29791.1-2013, 3.73]
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Quality control procedures
5 Validation of quality control procedures
6 Recommendations to users
Bibliography
