GB/T 19702-2021In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (English PDF)

Foreword

This Standard is drafted in accordance with the rules given in GB/T 1.1-2009.

This Standard replaces GB/T 19702-2005 "In vitro diagnostic medical devices

- Measurement of quantities in samples of biological origin - Description of

reference materials". Compared with GB/T 19702-2005, the main technical

changes of this Standard are as follows:

- In the scope, add "This Standard specifies requirements for the content of

a reference measurement procedure for in vitro diagnostic medical devices

and medical laboratories." and "This Standard applies to reference

measurement procedures providing values of differential or rational

quantities. Annex A provides information on nominal properties and ordinal

quantities." (see Clause 1);

- ADD the terms and definitions of "analytical sensitivity", "detection limit" and

"calibrator" (see Clause 3);

- CHANGE the "quality assurance" element from an optional element to a

mandatory element; CHANGE the "foreword", "normative references" and

"special cases" elements from mandatory elements to optional elements

(see Table 1);

- Delete the content of 4.2.2 in "Warning and safety precautions" (see 4.2.2

of the 2005 edition);

- Modify the subclause name: Modify "4.5 Terms" to "4.5 Terms, definitions,

symbols and abbreviated terms" (see 4.5; 4.5 of the 2005 edition);

- Modify the subclause name: Modify "4.8 Reagents" to "4.8 Reagents and

materials" (see 4.8; 4.8 of the 2005 edition);

- Modify the subclause name: Modify "4.16 Verification by inter-laboratory

research" to "4.16 Validation of a reference measurement procedure" (see

4.16; 4.16 of the 2005 edition);

- In "4.10.2 Samples", add "Requirements for the primary sample shall be

specified in terms of required sample container and/or sample handling

procedure, as required to minimize changes of the measurand (e.g. loss

and/or contamination)" (see 4.10.2);

- ADD the content of "4.14.13 Intermediate precision standard deviation"

(see 4.14.13);

- Modify the title of Annex A: Modify "Reference procedures for parameters

other than quantities" to "Reference procedures for properties other than

differential and rational quantities" (see Annex A; Annex A of the 2005

edition).

This Standard, using translation method, is identical to ISO 15193:2009 "In vitro

diagnostic medical devices - Measurement of quantities in samples of biological

origin - Requirements for content and presentation of reference measurement

procedures".

China's document which has a consistent correspondence with the international

document normatively referenced in this Standard is as follows:

- GB/T 27418-2017 Guide to the evaluation and expression of uncertainty in

measurement (ISO/IEC Guide 98-3:2008, MOD).

This Standard was proposed by National Medical Products Administration.

This Standard shall be under the jurisdiction of National Technical Committee

136 on System of Medical Clinical Test Lab and in Vitro Diagnostic System of

Standardization Administration of China (SAC/TC 136).

Drafting organization of this Standard: Beijing Institute of Medical Device

Testing.

Main drafters of this Standard: Yang Zongbing, Kang Juan, He Xueying, Wang

Huiru.

The previous editions of the standard replaced by this Standard were released

as follows:

- GB/T 19702-2005.

In vitro diagnostic medical devices - Measurement of

quantities in samples of biological origin -

Requirements for content and presentation of

reference measurement procedures

1 Scope

This Standard specifies requirements for the content of a reference

measurement procedure for in vitro diagnostic medical devices and medical

laboratories.

Note 1: It is intended that an experienced laboratory worker who follows a measurement

procedure written in accordance with this Standard can be expected to produce

measurement results with a measurement uncertainty not exceeding the stipulated

interval.

This Standard applies to reference measurement procedures providing values

of differential or rational quantities. Annex A provides information on nominal

properties and ordinal quantities.

This Standard is valid for any person, body or institution involved in one of the

various branches of laboratory medicine whose intention is to write a document

to serve as a reference measurement procedure.

Full descriptions of measurement methods are usually published in scientific

literature, in which methods are described in sufficient detail that they can be

used as the basis of a documented measurement procedure.

Note 2: In this Standard, "international measurement standard" designates a material

standard. The term "international standard" is used by WHO for reference materials.

2 Normative references

The following documents are indispensable for the application of this document.

For the dated references, only the editions with the dates indicated are

applicable to this document. For the undated references, the latest edition

(including all the amendments) are applicable to this document.

ISO 15194 In vitro diagnostic medical devices - Measurement of quantities

......