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 ...