YY/T 0659-2017 (YY/T0659-2017, YYT 0659-2017, YYT0659-2017) & related versions
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YY/T 0659-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Replacing YY/T 0658-2008 and YY/T 0659-2008
Blood coagulation analyzer
ISSUED ON. MARCH 28, 2017
IMPLEMENTED ON. APRIL 1, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 6
4 Product classification ... 8
5 Technical requirements ... 8
6 Test methods ... 10
7 Labelling, marking and instructions for use ... 14
8 Packaging, transportation and storage ... 15
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard integrates YY/T 0658-2008, Semi-automated coagulation analyzer, and
YY/T 0659-2008, Automated coagulation analyzer. Compared with YY/T 0658-2008
and YY/T 0659-2008, in addition to editorial changes, the major technical changes are
as follows.
-- it changes the standard name, from “Semi-automated coagulation analyzer” and
“Automated coagulation analyzer” into “Blood coagulation analyzer”;
-- it changes the scope, adds the specification that this Standard does not apply to
the instruments for platelet aggregation function testing, hemorheological function
testing and point-of-care testing, and add the specification that it only applies to
the instruments for coagulation method (see Clause 1);
-- the text description in the normative references is drafted as specified in GB/T
1.1-2009;
-- all the normative reference documents are not dated, i.e. their latest editions apply
to this Standard;
-- the terms and definitions of accuracy, precision, linearity and carry-over rate are
the references to the commonly-used terms and definitions listed in GB/T 29791.1
(see Clause 3);
-- it changes the sample requirements in the precision items, adds the requirements
for normal samples and deletes the requirements for abnormal samples (higher
than 2 times of normal samples) (see 5.7);
-- it changes the requirements for the linearity index r, r ≥ 0.980 (see 5.9);
-- it adds the requirements for the linearity deviation (see 5.9);
-- it changes the requirements for continuous working hours, changes the
continuous working hours from 24 h into 8 h and changes the requirements (see
5.10);
-- it adds the safety requirements of GB 4793.9 and YY 0648 (see 5.13);
-- it adds the electromagnetic compatibility requirements of GB/T 18268.1 and GB/T
18268.26 (see 5.14);
-- it changes the test method of carry-over rate (see 6.6);
Blood coagulation analyzer
1 Scope
This Standard specifies the terms and definitions, product classification, technical
requirements, testing methods, labelling, marking, instructions for use, packaging,
transportation and storage for blood coagulation analyzers.
This Standard applies to blood coagulation analyzers which are used clinically for the
analysis of coagulation-anticoagulation and fibrinolysis-antifibrinolysis of patients’
blood. This Standard does not apply to the instruments for platelet aggregation function
testing, hemorheological function testing and point-of-care testing.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition dated applies to this document. For
undated references, the latest edition of the referenced documents (including all
amendments) applies to this document.
GB/T 191, Packaging – Pictorial marking for handling of goods
GB 4793.1, Safety requirements for electrical equipment for measurement, control,
and laboratory use – Part 1. General requirements
GB 4793.9, Safety requirements for electrical equipment for measurement, control
and laboratory use – Part 9. Particular requirements for automatic and semi-
automatic laboratory equipment for analysis and other purposes
GB/T 14710, Environmental requirement and test methods for medical electrical
equipment
GB/T 18268.1, Electrical equipment for measurement, control and laboratory use
– EMC requirements – Part 1. General requirements
GB/T 18268.26, Electrical equipment for measurement, control and laboratory use
– EMC requirements – Part 26. Particular requirements – In vitro diagnostic (IVD)
medical equipment
GB/T 29791.1, In vitro diagnostic medical devices – Information supplied by the
manufacturer(labelling) – Part 1. Terms, definitions and general requirements
4 Product classification
4.1 Automation degree classification
Semi-automated and full-automated.
4.2 Channel type classification (semi-automated)
Single-channel, double-channel and multiple-channel.
5 Technical requirements
5.1 Preheating time
Preheating time shall be less than 30 min.
5.2 Temperature control
5.2.1 The temperature of the reaction system in the testing part and the thermostat
part at the incubation location shall be controlled at 37.0°C ± 1.0°C.
5.2.2 The temperature of the reagent cooling location shall not be higher than 20°C.
5.3 Testing items and reporting units
The testing items shall at least include the determination of prothrombin time (PT),
activated partial thromboplastin time (APTT), fibrinogen (FIB) and thrombin time (TT).
PT, APTT and TT are reported in s. The determination result of PT shall also be
reported using the international normalized ratio (INR). The reporting unit of FIB is g/L
or mg/dL. The reporting unit of coagulation factor activity (for full-automated analyzers)
is U/L or %.
5.4 Channel difference (applicable to semi-automated analyzers)
The maximum difference between the results obtained from different channels is ≤
10%.
5.5 Carry-over rate (applicable to full-automated analyzer)
5.5.1 The carry-over rate of sample concentration. the carry-over rate of FIB (g/L)
shall be ≤ 10%.
5.5.2 The carry-over rate of FIB or TT to PT or APTT shall meet the nominal level of
the manufacturer.
6.1.3 The relative humidity. ≤ 80%.
6.1.4 The atmospheric pressure. 86.0 kPa ~ 106.0 kPa.
NOTE. When the conditions specified in 6.1.1 ~ 6.1.4 are different from the nominal conditions
of the manufacturer, the conditions specified for products shall prevail.
6.2 Preheating time
Carry out testing as required by the manufacturer after starting up.
6.3 Temperature control
Carry out testing in accordance with a method provided by the manufacturer.
6.4 Testing items and reporting units
Operate in accordance with the instrument instructions; use the parameters of all items
set for instruments for verification. If necessary, instruments can be used together with
matched reagents and plasma samples for testing verification.
6.5 Channel difference (applicable to semi-automated analyzers)
Under normal conditions, test continuously the PT, APTT, TT and FIB of the same
normal sample for three times respectively in different channels. Calculate respectively
the arithmetic mean value of the measured values in all channels (Xi) and the overall
mean value of the measured values in all channels (Xoverall); then calculate the channel
difference (R) in accordance with Formula (1).
where.
R – the difference between channels;
Xmax – the maximum value of the arithmetic mean values of the values measured in all
channels;
Xmin – the minimum value of the arithmetic mean values of the values measured in all
channels;
Xoverall – the overall arithmetic mean value of the values measured in all channels.
6.6 Carry-over rate (applicable to full-automated analyzers)
6.6.1 Carry-over rate of sample concentration
Overall
concentration points; calculate the deviation and correlation coefficient r between the
mean value measured and the theoretical value.
where.
r – the correlation coefficient;
X – the mean value of X;
Y – the mean value of Y.
6.11 Continuous working hours
Test a normal sample for 3 times after starting up; calculate the mean value of the 3
results measured; maintain the coagulation analyzer continuously in the on state or
ready state for 8 h; test the same normal sample for 3 times after 8 hours; calculate
the mean value of the 3 results measured. Calculate the relative deviation of two mean
values.
6.12 Appearance
Use the normal or corrected visual acuity to carry out visual inspection under natural
light.
6.13 Environmental test
The method for environmental test shall be as specified in the applicable clauses of
GB/T 14710.
6.14 Safety
The method for safety test method shall be as specified in the applicable clauses of
GB 4793.1, 4793.9 and YY 0648.
6.15 Electromagnetic compatibility
The method for electromagnetic compatibility test shall be as specified in the applicable
clauses of GB/T 18268.1 and GB/T 18268.26.
7 Labelling, marking and instructions for use
As specified in GB/T 29791.3.
......
| Standard ID | YY/T 0659-2017 (YY/T0659-2017) | | Description (Translated English) | Blood coagulation analyzer | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 10,133 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Older Standard (superseded by this standard) | YY/T 0659-2008; YY/T 0658-2008 | | Drafting Organization | Beijing Medical Device Testing Center, Beijing Medical Device Technical Evaluation Center, Sisi Meikang Medical Electronics (Shanghai) Co., Ltd., Beijing Saikeheid Technology Development Co., Ltd., Beijing Qin Shi Di Biotechnology Co., Ltd., Beijing Pu Lee Health Instruments Co., Ltd., Wofen Medical Devices Trading Company | | Administrative Organization | National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC 136) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 38 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration |
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