YY/T 1768.1-2021 PDF EnglishUS$605.00 · In stock · Download in 9 seconds
YY/T 1768.1-2021: Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsYY/T 1768.1-2021: Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1768.1-2021 YY PHARMACEUTICAL INDUSTRY STANDARD 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 ContentsForeword... 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... 57ForewordYY/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 ScopeThis 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 referencesThe 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 abbreviations3.1 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). 3.1.6 "dose delivered" indication The number displayed in the dose window indicating the dose of the drug product to be delivered. 3.1.7 manufacturer-filled A container that is prefilled with a drug by a drug manufacturer and is supplied to a user. 3.1.8 minimum deliverable dose The manufacturer ensures that in a single-dose manufacturer-filled needle-based injection system, the minimum dose delivered is designed to the one that can empty the container. 3.1.9 needle-based injection system An injection system for injecting parenteral drugs through the use of a needle and a multi-dose or single-dose container. 3.1.12 user packaging A package or set of identical needle-based injection systems from the same manufacturing lot provided to the user, including instructions for use. 3.1.13 user-filled Containers filled by the user from individual drugs or container after reconstitution with diluent (if drug product is lyophilized). 3.2 Symbols and abbreviations The following symbols and abbreviations apply to this document. DR. Set resolution, the smallest adjustable increment of NIS. NIS. Needle-based injection system. RF. Radiated radio frequency. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY/T 1768.1-2021 be delivered?Answer: The full copy PDF of English version of YY/T 1768.1-2021 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of YY/T 1768.1-2021_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1768.1-2021_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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