YY/T 1768.1-2021 English PDF (YYT1768.1-2021)

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YY/T 1768.1-2021: Needle-based injection systems for medical use -- Requirements and test methods -- Part 1: Needle-based injection systems
YY/T 1768.1-2021
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Needle-based injection systems for medical use -
Requirements and test methods - Part 1: Needle-based
injection systems
(ISO 11608-1:2014, NEQ)
ISSUED ON: MARCH 09, 2021
IMPLEMENTED ON: APRIL 01, 2022
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 4 
Introduction ... 5 
1 Scope ... 6 
2 Normative references ... 6 
3 Terms and definitions, symbols and abbreviations ... 7 
3.1 Terms and definitions ... 7 
3.2 Symbols and abbreviations ... 9 
4 Requirements ... 11 
4.1 General ... 11 
4.2 System classification ... 11 
4.3 Risk analysis requirements ... 12 
4.4 Measurement uncertainty and specification compliance ... 12 
5 General design requirements ... 12 
6 Reliability requirements ... 14 
6.1 General ... 14 
6.2 Cool, standard, warm atmospheres ... 18 
6.3 Final dose accuracy (for systems classified as A and C only) ... 18 
6.4 Life cycle test (only for systems classified as A and B) - Pretreatment ... 19 
6.5 Free fall test ... 19 
6.6 Dry heat and frozen storage tests - Pretreatment ... 19 
6.7 Damp heat test (for systems classified as A and B only) - Pretreatment ... 20 
6.8 Circulation test (only for systems classified as A and B) - Pretreatment ... 20 
6.9 Vibration Test – Pretreatment ... 20 
6.10 Electromagnetic compatibility (EMC) ... 20 
7 Information provided by manufacturer ... 22 
7.1 General ... 22 
7.2 Marking ... 22 
7.3 Instructions for use ... 23 
Annex A (normative) Test instruments ... 26 
Annex B (normative) Test method for dose accuracy ... 27 
Annex C (normative) Visual inspection and container inspection ... 36 
Annex D (informative) Dose combinations, accuracy and test description ... 37 
Annex E (normative) Free fall test ... 39 
Annex F (informative) Illustration ... 41 
Annex G (normative) Unilateral and bilateral tolerance factor k ... 45 
Bibliography ... 57 
Needle-based injection systems for medical use -
Requirements and test methods - Part 1: Needle-based
injection systems
1 Scope
This Part of YY/T 1768 specifies the requirements and test methods for needle-based
injection systems.
This Part applies to needle-based injection systems intended for use with needles and
containers, such as pen injectors.
The containers described in this Part include single-dose, multi-dose syringe systems
and cartridge systems filled by the manufacturer or end user.
This Part does not apply to needleless syringes.
This Part does not address requirements and related methods for filling containers and
appliances by the end user.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB/T 2423.4-2008, Environmental testing for electric and electronic products - Part
2: Test method - Test Db: Damp heat, cyclic (12 h + 12 h cycle) (IEC 60068-2-
30:2005, IDT)
GB/T 2423.10-2019, Environmental testing - Part 2: Test methods - Test Fc:
Vibration (sinusoidal) (IEC 60068-2-6:2007, IDT)
GB/T 3359-2009, Statistical interpretation of data - Determination of statistical
tolerance intervals (ISO 16269-6:2005, IDT)
GB/T 16886.1, Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process (GB/T 16886.1-2011, ISO 10993-1:2009,
IDT)
GB/T 18779.1, Geometrical Product Specifications (GPS) - Inspection by
measurement of workpieces and measuring equipment - Part 1: Decision rules for
proving conformance or non-conformance with specifications (GB/T 18779.1-2002,
eqv ISO 14253-1:1998)
GB/T 27418, Guide to the evaluation and expression of uncertainty in measurement
(GB/T 27418-2017, ISO/IEC Guide 98-3:2008, MOD)
YY/T 0316-2016, Medical devices - Application of risk management to medical
devices (ISO 14971:2007 Corrected version, IDT)
YY/T 0664-2008, Medical device software - Software life cycle processes (IEC
62034:2006, IDT)
YY/T 1474-2016, Medical devices - Application of risk management to medical
devices (IEC 62366:2007, IDT)
YY 9706.102-2021, Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests (IEC 60601-1-2:2007, MOD)
YY/T 1768.2, Needle-based injection systems for medical use - Requirements and
test methods - Part 2: Needles (YY/T 1768.2-2021, ISO 11608-2:2012, NEQ)
ISO 11608-3, Needle-based injection systems for medical use - Requirements and
test methods - Part 3: Finished containers
ISO 11608-4, Needle-based injection systems for medical use - Requirements and
test methods - Part 4: Needle-based injection systems containing electronics
ISO11608-5, Needle-based injection systems for medical use - Requirements and test
methods - Part 5: Automated functions
3 Terms and definitions, symbols and abbreviations
3.1 Terms and definitions
The following terms and definitions apply to this document.
3.1.1 cap
A component used in a needle-based injection system to protect the syringe and its
contents.
3.1.2 container
A primary packaging that contains injectable drug product (single or multi-chamber).
5.6 The NIS shall at least visually indicate that the system is ready for injection.
5.7 The state in which the NIS is ready to administer the dose shall be different from
the state in which the preset dose is delivered. The difference shall be visible.
5.8 The NIS shall indicate by visual, auditory or tactile means or any combination that
the injection is complete.
5.9 The NIS systematically classified as D2 shall be designed so that the residual
volume cannot be delivered after injection. And the injector cannot be restarted.
5.10 Adjustable multi-dose NIS (systems classified as A and C) shall be designed such
that they:
a) Do not allow the pre-setting to exceed the residual dose in the container; or
b) If the pre-setting exceeds the residual dose in the container, the dose is not
permitted; or
c) Indicate the dose to be delivered; or
d) Indicate the dose not delivered (of a pre-setting dose).
5.11 For fixed multiple-dose NIS, if the residual dose is not enough for a pre-setting
dose, the pre-setting dose shall not be allowed.
5.12 The NIS shall be designed to be used with its designated needle. YY/T 1768.2
provides guidelines for needles.
5.13 The NIS shall be designed to be used with its prescribed container. ISO 11608-3
provides guidelines for containers.
5.14 If the NIS contains electronic or electromechanical components and/or software,
the requirements of ISO 11608-4 shall be met.
5.15 If the NIS has automatic function, it shall meet the requirements of ISO 11608-5.
5.16 For the NIS containing replaceable batteries, to avoid unintentional removal, the
battery shall not be removed unless two separate actions are applied.
5.17 If it is designed with small components that may be swallowed, the NIS shall have
warnings to prevent exposure to children under 3 years of age.
5.18 If the NIS contains a battery, its design shall enable the user to determine the state
of the power supply.
5.19 If NIS includes software, its software shall be designed according to the life cycle
model of YY/T 0664-2008. NIS shall meet the applicable requirements of YY/T 0664-
2008, including connection with other equipment.
5.20 The risk analysis shall be as described in YY 9706.102-2021 and shall consider
the use of alarms (if applicable).
5.21 Risk assessment methods shall be used to assess the adverse effects of drugs after
exposure to NIS. Take appropriate risk control measures to reduce its risk.
5.22 The biological evaluation of NIS shall be carried out according to GB/T 16886.1.
NOTE: The design process preferably incorporates environmentally friendly design (see IEC
60601-1-9).
5.23 If in the requirements of this Part, only the test method is provided without
specifying the acceptance criteria, the manufacturer shall adopt the risk-based method
(complies with YY/T 0316-2016 and YY/T 1474-2016). Establish technical
specifications and acceptance criteria appropriate to the intended use of the syringe.
6 Reliability requirements
6.1 General
6.1.1 NIS performance shall be stable and reliable. After the NIS prepared according to
the instructions for use is pretreated for each test specified in 6.2 to 6.10, place the NIS
with the container and the unconnected needle under standard conditions of temperature
(23 ± 5)°C and relative humidity (50 ± 25)% (unless otherwise specified in the test
method) for at least 4h. The test requirements specified in 6.1.2 and 6.1.3 shall be met.
NOTE: Table 2 summarizes the test matrix requirements for each classification system.
6.1.2 When using the test apparatus in accordance with Annex A and the method
specified in Annex B, the accuracy of NIS1 shall meet the acceptance criteria given in
B.3.2.
6.1.3 The NIS shall meet the requirements for visual inspection specified in C.1 of
Annex C and container inspection specified in C.2.
NOTE: After pretreatment in 6.2, 6.3, 6.4, 6.6 and 6.7, no inspection of the containers in the system
is required.
1 See Annex D for a description of the accuracy of NIS.
The requirements given in 6.10.2 and 6.10.4 supersede those general requirements
specified in YY 9706.102-2021 that apply only to electronic medical devices. YY
9706.102-2021 does not involve requirements for special devices such as NIS.
NOTE: The tests specified in 6.10.2 and 6.10.4 are based on the requirements given in the EMC
collateral standard YY 9706.102-2021. Except for the following cases, YY 9706.102-2021 applies.
6.10.2 Exposure to electrostatic discharge - Pretreatment
Test according to YY 9706.102. Replace the test requirements with the following.
Apply contact discharges of ±2kV, ±4kV and ±8kV to conductive accessible
components and coupling planes.
Apply air discharges of ±8kV, ±10kV, ±12kV, and ±15kV to non-conductive accessible
components.
NOTE: This clause takes precedence over 11.1.1 of ISO 11608-4:2006. Refer to the first edition of
ISO 11608.
6.10.3 Compliance guidelines for electrostatic discharge
Visually inspect the performance of 20 new NISs with electronic components (such as
stored data, settings, doses or instructions). A smaller sample size can be justified in the
risk management report.
NIS shall meet the following requirements:
a) When tested in accordance with 6.10.2, all NIS shall have no visible defects after
each and all required electrostatic discharges.
b) When evaluated according to the requirements specified in 6.2.1.10 and 6.2.1.11
of YY 9706.102-2021, the performance of NIS shall not be changed due to the
application of the test. According to the provisions of Annex C, all NIS shall be free
of functional defects.
6.10.4 Radiated radio frequency (RF) fields - Pretreatment
Carry out the test according to 6.2.3 of YY 9706.102-2021. For the frequency range of
26MHz~2500MHz, the test level shall be 10V/m. Carry out the test on each of the three
axes of the NIS.
6.10.5 Compliance guidelines for radiated radio frequency (RF) fields
Visually inspect the performance of 20 new NISs with electronic components (such as
stored data, settings, doses or instructions). A smaller sample size can be justified in the
risk management report.
NIS shall meet the following requirements:
a) When tested in accordance with 6.10.4, during the RF scan, all NIS shall not show
false indications.
b) After the RF scan, the performance of the NIS shall be checked. When evaluated
according to the requirements specified in 6.2.1.10 and 6.2.1.11 of YY 9706.102-
2021, the performance of NIS shall not be changed due to the application of the test.
As specified in Annex C, all NISs shall be free of functional defects.
7 Information provided by manufacturer
7.1 General
NIS shall be accompanied by adequate information on safe use, considering the training
and knowledge of potential users. This information shall include the manufacturer's
identification. Instructions for use shall be included in the user packaging.
7.2 Marking
7.2.1 General
Any markings provided on user packaging for safe use of NIS shall be legible. It shall
be inspected by visual inspection (normal or corrected vision observation) under the
conditions of ambient lighting (215±20) lx and viewing distance of 40cm~70cm.
7.2.2 Marks on NIS
The marking on the NIS includes at least the following information/content:
a) Manufacturer's name or trademark;
NOTE: The trademark may be enough to identify the manufacturer.
b) Details required by the user to identify the NIS;
c) Batch code, batch number or serial number, beginning with the corresponding
symbol.
7.2.3 Marks on user packaging
Unless otherwise specified in the corresponding standard for a particular syringe, the
marking on the user package shall include at least the following information/content:
a) Manufacturer's name and address;
Annex A
(normative)
Test instruments
A.1 General
When the required accuracy (calibration) and precision (Gauge R and R) can be obtained,
any suitable test system can be used. The repeatability and reproducibility (Gauge R and R)
of the test apparatus shall not be greater than 20% of the allowable tolerance range for
any given measurement. For destructive test measurements, Gauge R and R shall not be
greater than 30% of the allowable tolerance range. Its Gauge R and R shall contain at least
±2 standard deviations (thus covering approximately 95% of the variance).
Example:
The measurement system with a measurement specification limit of ±0.01 mL (0.02 mL
range) is from a Gauge R and R with a Gauge R and R/tolerance range ratio of 20%. This
means that its Gauge R and R (4 times standard uncertainty) is equa...