YY/T 1768.1-2021Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (English PDF)

Foreword

YY/T 1768 "Needle-based injection systems for medical use - Requirements and test

methods" consists of the following parts.

- Part 1.Needle-based injection systems;

- Part 2.Needles;

- Part 3.Containers;

- Part 4.Electronic and electromechanical pen injectors;

- Part 5.Automatic functions;

- Part 7.Accessibility services for the visually impaired.

This Part is Part 1 of YY/T 1768.

This Part was drafted in accordance with the rules given in GB/T 1.1-2009.

This Part uses redrafting method to refer to ISO 11608-1.2014 "Needle-based injection

systems for medical use - Requirements and test methods - Part 1.Needle-based

injection systems". The degree of conformity with ISO 11608-1.2014 is non-equivalent.

Attention is drawn to the possibility that some of the elements of this document may be

the subject of patent rights. The issuing authority shall not be held responsible for

identifying any or all such patent rights.

This Part was proposed by National Medical Products Administration.

This Part shall be under the jurisdiction of National Technical Committee on Medical

Syringe (Needle) of Standardization Administration of China (SAC/TC 95).

The drafting organizations of this Part. Shandong Weigao Group Medical Polymer

Products Co., Ltd., Shanghai Medical Device Testing Institute, China National Institute

for Food and Drug Control, Novo Nordisk (China) Pharmaceutical Co., Ltd., Shanghai

Food and Drug Administration Certification and Evaluation Center.

Main drafters of this Part. Li Weiyang, Liu Xinglin, Zhang Binbin, Fu Bufang, Qian

Yujun, Liu Qun.

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)

3 Terms and definitions, symbols and abbreviations