YY/T Translated English of Chinese Standard: YY/T PHARMACEUTICAL INDUSTRY STANDARD

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1 Translated English of Chinese Standard: YY/T Buy True-PDF Auto-delivery. PHARMACEUTICAL INDUSTRY STANDARD YY OF THE PEOPLE S REPUBLIC OF CHINA ICS C 36 YY/T Disposable cut of the umbilical cord 一次性使用脐带剪 ( 切 ) 断器 Issued on: January 26, 2016 Implemented on: January 1, 2017 Issued by: China Food and Drug Administration Buy True-PDF Auto-delivery. Page 1 of 13

2 Table of Contents Foreword Scope Normative References Structural styles Requirements Test methods Inspection rules Marking and operation instructions Packaging, transportation and storage Buy True-PDF Auto-delivery. Page 2 of 13

3 Foreword This Standard was drafted in accordance with the rules given in GB/T Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuer of this document shall not be held responsible for identifying any or all such patent rights. This Standard was proposed by and shall be under the jurisdiction of Technical Committee 169 on Family Planning Instruments of Standardization Administration of China (SAC/TC 169). The drafting organizations of this Standard: Jiangsu Sinolinks Mecial Innovation Inc., Shanghai Testing and Inspection Institute for Medical Devices, Shanghai Hengyi Weighing and Instrument Co., Ltd. The main drafters of this Standard: Tian Runting, Yao Tianping, Weng Binghao, Zou Bing, Jiang Songbo. Buy True-PDF Auto-delivery. Page 3 of 13

4 Disposable cut of the umbilical cord 1 Scope This Standard specifies the structural styles, requirements, test methods, inspection rules, marking and operation instructions, packaging, transportation and storage for disposable cut of the umbilical cord. This Standard applies to disposable cut of the umbilical cord. The product is used to clamp and cut the newborn umbilical cord during obstetrical delivery. 2 Normative References The following referenced documents are indispensable for the application of this document. For dated references, only the edition dated applies to this document. For undated references, the latest edition of the referenced documents (including all amendments) applies to This Standard. GB/T 191, Packaging Pictorial marking for handling of goods GB/T , Sampling procedures for inspection by attributes - Part1: Sampling schemes indexed by acceptance quality limit(aql) for lot-by-lot inspection GB/T 2829, Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability) GB , Cold rolled stainless steel plate, sheet and strip GB/T , Metallic materials - Vickers hardness test - Part 1: Test method GB/T 9969, General principles for preparation of instructions for use of industrial products GB/T , Test methods for infusion, transfusion, injection equipment for medical use - Part 1: Chemical analysis methods GB/T , Biological evaluation of medical devices - Part 1: Evaluation and testing GB/T , Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity GB/T , Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity Buy True-PDF Auto-delivery. Page 4 of 13

5 YY/T , Silicone tubes and elastomeric parts for infusion and transfusion YY/T , Medical instruments of stainless steel - Test methods of corrosion resistance YY/T 0171, Surgical instruments - packaging, marking and instructions Pharmacopoeia of the People's Republic of China, Fourth Part (2015 Edition) 3 Structural styles 3.1 Disposable cut of the umbilical cord comprises umbilical cord clamp, knife rest and cutting knife. See Figures 1 and 2 for its structural styles. Other structural styles can also be used if they meet the requirements of this Standard. 3.2 Umbilical cord and knife rest are made of high polymer materials. Cutting knife shall be made of stainless steels 20Cr13 and 12Cr18Ni9 specified in GB Other materials can also be used if they meet the requirements of this Standard. Umbilical cord clamp Cutting knife Knife rest a) Push-cut style Buy True-PDF Auto-delivery. Page 5 of 13

6 Umbilical cord clamp Cutting knife Knife rest b) Shear-cut style Figure 1 Umbilical cord cut (diagram) Figure 2 Umbilical cord clamp (diagram) 4 Requirements 4.1 Appearance The outer surface of disposable cut of the umbilical cord shall be bright and clean without sharp edges, burrs or cracks. Buy True-PDF Auto-delivery. Page 6 of 13

7 4.1.2 The surface of cutting knife shall be smooth without oil contamination, rust or broken edge. 4.2 Dimensions The dimensions of umbilical cord clamp shall meet the requirements of Table 1. Table 1 Basic dimensions and tolerances Dimensions in mm Dimension of umbilical cord clamp Dimension Tolerance L 50 ~ 60 ± 2 L1 5 ~ 7 ± Cutting blade Surface roughness The surface roughness of cutting blade shall not be greater than 0.8 μm Hardness The hardness of cutting blade shall not be less than 377 HV Corrosion resistance Cutting blade shall be well corrosion resistant. Its corrosion resistance shall be as specified for grade b of the boiling test method of YY/T Service performance Cutting performance Disposable cut of the umbilical cord shall have good cutting performance Clamping performance Disposable cut of the umbilical cord shall have good clamping performance, which shall be capable of bearing a 15 N static load Fitting performance The push frame of disposable cut of the umbilical cord shall have good fitting performance, which shall be free from falling-off, jamming etc. during cutting. 4.5 Sterility For the sterilization through a confirmed sterilization process, the sterilized disposable cut of the umbilical cord shall be sterile. 4.6 Ethylene oxide residue Buy True-PDF Auto-delivery. Page 7 of 13

8 If disposable cut of the umbilical cord is sterilized using ethylene oxide, the residue of ethylene oxide shall not be greater than 10 μg/g. 4.7 Biological evaluation In vitro cytotoxicity The cytotoxic reaction of disposable cut of the umbilical cord shall not be greater than grade Delayed-type hypersensitivity Disposable cut of the umbilical cord shall not cause delayed-type hypersensitivity Intradermal reaction Compare test sample of disposable cut of the umbilical cord and solvent; and the average difference between scores shall not be greater than Test methods 5.1 Appearance Use normal or corrected visual acuity to check and use hand to feel. It shall be as specified in Use normal or corrected visual acuity to check. It shall be as specified in Dimensions Use general measuring tools for measurement. They shall be as specified in Cutting blade Surface roughness Use a surface roughness comparison specimen or the electrical measuring method for measurement; use the electrical measuring method in arbitration; and it shall be as specified in Hardness Conduct test using the method specified in GB/T It shall be as specified in Corrosion resistance Conduct test using the boiling method specified in YY/T It shall be as specified in Buy True-PDF Auto-delivery. Page 8 of 13

9 5.4 Service performance Cutting performance Use the infusion tube 5 mm 7 mm specified in Table 1 of YY/T ; and simulate the movement of shearing (cutting). The cut surface of the infusion tube shall be smooth without adhesion; and the cutting blade shall not be curved or broken. It shall be as specified in Clamping performance Use an umbilical cord clamp to clamp the infusion tube specified in 5.4.1; use a fixture to fix the umbilical cord clamp which has clamped the infusion tube; apply a 15 N static load to the other end of the tube; and continue for 10 s. It shall be as specified in Fitting performance Simulate the shearing (cutting) movement; and clamp the umbilical cord before the infusion tube specified in not to let it fall off. It shall not be jammed during shearing after the infusion tube is clamped. It shall be as specified in Sterility Conduct test using the sterility test method 1101 specified in Pharmacopoeia of the People's Republic of China (Fourth Part) (2015 Edition). It shall be as specified in Ethylene oxide residue Conduct test using the ethylene oxide residue test method specified in GB/T It shall be as specified in Biological evaluation In vitro cytotoxicity Conduct test using the method specified in 8.2 (the extract liquid test) of GB/T Delayed-type hypersensitivity Conduct test using the method specified in 7.4 (the maximum dose test) of GB/T It shall be as specified in Intradermal reaction Conduct test using the method specified in Annex B.2 (the intradermal reaction test) of GB/T It shall be as specified in Buy True-PDF Auto-delivery. Page 9 of 13

10 6 Inspection rules 6.1 Acceptance Disposable cut of the umbilical cord shall be subjected to the inspection conducted by the quality inspection department of the manufacturer. They shall be submitted for acceptance when they pass the inspection. 6.2 Inspection method Disposable cut of the umbilical cord shall be submitted for inspection in batches. Inspection is divided into batch-by-batch inspection (exit-factory inspection) and periodic inspection (type inspection). 6.3 Batch-by-batch inspection Batch-by-batch inspection is conducted as specified in GB/T The sampling program is of single sampling. The stringency of the sampling program starts from a normal inspection sampling program. Its nonconformity classification, inspection groups, inspection items, inspection levels and acceptable quality levels (AQL) are as specified in Table 2 (in terms of nonconforming product number per 100 product units). Nonconformity classification Table 2 Batch-by-batch inspection Category A Category B Category C Inspection group I I I Inspection items 4.5, , , 4.2 Inspection level - S-2 S-3 Acceptable quality limit (AQL) All pass inspection Periodic inspection Under the following circumstances, periodic inspection shall be conducted: a) before the commissioning for a new product (including the production of an old product transferred to a new factory); b) when production is resumed after more than 1 year; c) when there is any significant change in product design, process or material; d) once every two years during the continuous production of a product; e) when the national quality supervision and inspection department requires. Buy True-PDF Auto-delivery. Page 10 of 13

11 6.4.2 Periodic inspection shall be conducted as specified in GB/T The sampling program is of single sampling. Its nonconformity classification, test groups, inspection items, decision levels, rejectable quality levels (RQL) and sampling programs are as specified in Table 3 (in terms of nonconforming product number per 100 product units). Nonconformity classification Table 3 Periodic inspection Category A Category B Category C Inspection group I I I Inspection items 4.5, 4.6, , , 4.2 Inspection level Rejectable quality limit (RQL) All pass inspection I Sampling program - 3[0.1] 5[1.2] 6.5 Revaluation of biological compatibility of product Under any of the following circumstances, in accordance with the specifications of GB/T , consider a revaluation of biological compatibility of materials and final product (and it can be exempted if there are no circumstances as follows). a) when the material source or technical specification for the manufacture of product changes; b) when the formula, process, primary package or sterilization of product changes; c) when it involves the operation instructions or any required changes of the manufacturer, e.g. the change of storage period; d) when the intended purpose of product changes; e) when there is any sign indicating bad effects exerts on human body after product is used. 7 Marking and operation instructions 7.1 Marking Product marking Each disposable cut of the umbilical cord shall be provided with company code or trademark Single package marking Buy True-PDF Auto-delivery. Page 11 of 13

12 The single package of disposable cut of the umbilical cord shall be marked legibly, and shall be marked as follows: a) manufacturer name or trademark; b) product name and product specification; c) product registration certificate number; d) batch number and date; e) words including sterile (and/or sterile graphic symbols), discard after use and sterile unless package is opened or damaged ; f) sterilization method and expiry date Outer package marking a) manufacturer name or trademark and address; b) product name and product specification; c) product registration number; d) word or graphic symbol of disposable ; e) sterile symbol; f) product quantity; g) expiry date Packaging box marking a) company name, trademark, address and contact telephone; b) product name, quantity and quality; c) product registration number or standard number; d) sterile batch number; e) gross weight and volume (L W H); f) relevant symbols of storage and transportation specified in GB/T 191, such as keep away from sunlight, keep away from rain and handle with care. 7.2 Operation instructions Operation instructions shall be as specified in GB/T 9969 and YY/T 0171, which shall indicate the following content: Buy True-PDF Auto-delivery. Page 12 of 13

13 a) company name, address and contact telephone; b) product name and registered trademark; c) product registration number, registered product standard number, medical device manufacturer license number; d) product performance, manufacturing material and main structure; e) disposable, discard after use, sterile unless package is opened or damaged, sterilization method and useful life and expiry date, and striking word sterile ; f) product application scope, contraindications, relevant matters needing attention and other content needing to be warned or reminded of; g) the requirements ensure the correct, safe use of product. 8 Packaging, transportation and storage 8.1 Packaging A single package shall contain one disposable cut of the umbilical cord, which shall be enclosed in a plastic bag and sealed. The small package shall be kept dry and clean The outer package of disposable cut of the umbilical cord shall be strong. Operation instructions and product certificate shall be enclosed in outer package. 8.2 Transportation The requirements for packing and transportation shall be as specified in the contract. 8.3 Storage Product shall be stored in a well-ventilated room at room temperature without corrosive gas, where the relative humidity is not greater than 80%. 8.4 Sterilization period For a sterilized disposable cut of the umbilical cord which is packaged and sealed in a bag, the sterilization period starting from the date of sterilization shall be indicated while the rules for storage are observed. END Buy True-PDF Auto-delivery. Page 13 of 13