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

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

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.
YY/T 1768.1-2021
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE 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&R) can be obtained, any suitable test system can be used. The repeatability and reproducibility (Gauge R&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&R shall not be greater than 30% of the allowable tolerance range. Its Gauge R&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&R with a Gauge R&R/tolerance range ratio of 20%. This means that its Gauge R&R (4 times standard uncertainty) is equal to
0.02mL/5=0.004mL. The uncertainty of this measurement is ??2 standard deviation (GUM), which is equal to 0.002mL.
All doses delivered Vset shall be recorded by weighing method, Gmeasurement [in grams (g)]. These records are converted to volume Vmeasurement at ambient conditions by using the density ?? of the test liquid [in grams per milliliter (g/mL)]. The weight measurement value can be converted to volume measurement value with the following formula: Vmeasurement = Gmeasurement/??
A.2 Test solution
The test solution is the original drug solution injected by NIS, or other liquid with similar physical properties.
A.3 Balance
The balance shall have a division value of at least 1% of the minimum delivered dose. A.4 Test surface for free fall test
The test surface shall be made of smooth, hard steel with a thickness of 3mm. The backside shall be made of wood with a thickness greater than 10mm.
needle-based system. For systems classified as D2, the dose resolution requirement does not apply.
For systems classified as A and C, according to the manufacturer's risk assessment, if a particular dose is handled differently than the other doses (for example, the first dose of a system that does not require pre-exhaust), then (after performing dose accuracy as described above) special considerations need to be taken when analyzing these particular data points:
a) Each particular data point from a container shall meet the dose accuracy requirements of the technical specification limits determined by the risk assessment; b) Those particular dose data points may be excluded from the statistical analysis of all other doses.
B.2.3.2 Unilateral dose accuracy limits (systems classified as B1 and D1) The methods are as follows:
a) For user-filled containers, the lower limit of the unilateral technical specification for the assessment of dose delivery efficiency is determined by the risk assessment. b) For manufacturer-filled containers, the lower limit of the unilateral technical specification for the minimum deliverable dose is determined by the drug label. NOTE: The unilateral (lower limit) case applies only to systems classified as B1 and D1. These two requirements are the higher the better.
B.2.4 Determination of final dose error and final dose accuracy limit (systems classified as A and C)
For adjustable dose syringes that are not allowed to set a dose greater than the residual volume, use Vset equal to Vmin or TP dose as described in B.2.3 to establish the dose accuracy limit (the manufacturer shall determine the choice based on risk assessment). For syringes with adjustable doses, if the set dose is allowed to be greater than the residual volume, the final dose can be assessed by the dose error. This is because normal variations in system dimensions make it impossible to set the exact same final dose for all syringes. To accurately evaluate the uncertainty of the final dose, it is necessary to evaluate a certain number of final doses. Those final doses are required to fall within 10% of TP, so as to calculate the mean dose error for each dose (ideally zero in the middle). The calculation of the single final dose error (expressed as a percentage) is shown in the example below. Use 0.20mL of TP:
a) In this example, the final dose within 0.18mL ~ 0.22mL can be used to determine the final dose accuracy, of which TP is 0.20mL. The range is ??10% of TP. The remaining final doses above or below this range cannot be used to determine final B.3 Assessment
B.3.1 General
Dose accuracy is an element required to meet NIS design specifications. If regulatory requirements are more stringent, or risk assessment requires, the acceptance criteria for dose accuracy shall be adjusted, so as to ensure that the system meets the requirements. If these regulatory requirements are not strict, the manufacturer can include them in the risk assessment as a basis for relaxing the acceptance criteria.
Select and test different numbers of NIS to determine dose accuracy. This number depends on the vessel and the accuracy requirements for a given test. In the specific case of user-filled single-dose, NIS needle systems designed to fully empty the container, it may use dose delivery efficiency to evaluate its accuracy. In the case of manufacturer-filled single-dose, NIS needle systems designed to fully empty the container, it may use minimum deliverable dose (that is, the marked volume) to evaluate the accuracy.
To pass the dose accuracy requirement, at a 95% confidence level, all doses delivered with at least probability p shall fall within all the upper and lower limits of the three doses recommended by the specification (one dose in the case of fixed-dose NIS). To pass the minimum deliverable dose requirement (for manufacturer-filled systems classified as B1 and D1), at a 95% confidence level, all doses delivered are greater than the lower limit of the specification with at least probability p. It is defined by the minimum deliverable dose stated on the drug label.
To pass dose delivery efficiency requirements (for systems with user-filled containers classified as B1 and D1), at a 95% confidence level, all delivered efficiency, as probability p, shall exceed the lower limit of dose efficiency according to technical specifications determined by risk assessment. Calculate the dose delivery efficiency according to B.2.5.
To pass the final dose accuracy requirement (for systems classified as A and C), when the syringe allows the set dose ...

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