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YY/T 1470-2016 English PDF (YYT1470-2016)

YY/T 1470-2016 English PDF (YYT1470-2016)

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YY/T 1470-2016: Disposable cut of the umbilical cord

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.
YY/T 1470-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.30
C 36
Disposable cut of the umbilical cord
ISSUED ON. JANUARY 26, 2016
IMPLEMENTED ON. JANUARY 1, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Structural styles ... 5
4 Requirements ... 6
5 Test methods ... 8
6 Inspection rules ... 10
7 Marking and operation instructions ... 11
8 Packaging, transportation and storage ... 13
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009. 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.
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 2828.1, Sampling procedures for inspection by attributes - Part 1. 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 3280-2015, Cold rolled stainless steel plate, sheet and strip
GB/T 4340.1-2009, 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 14233.1-2008, Test methods for infusion, transfusion, injection equipment for medical use - Part 1. Chemical analysis methods
GB/T 16886.1, Biological evaluation of medical devices - Part 1. Evaluation and testing
GB/T 16886.5-2003, Biological evaluation of medical devices - Part 5. Test for in vitro cytotoxicity
GB/T 16886.10-2005, Biological evaluation of medical devices - Part 10. Tests for irritation and delayed-type hypersensitivity
YY/T 0031-2008, Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0149-2006, 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 3280-2015. Other materials can also be used if they meet the requirements of this Standard. a) Push-cut style
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
4.1.1 The outer surface of disposable cut of the umbilical cord shall be bright and clean without sharp edges, burrs or cracks.
Umbilical
cord clamp
Cutting
knife Knife rest
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 ?? 0.5
4.3 Cutting blade
4.3.1 Surface roughness
The surface roughness of cutting blade shall not be greater than 0.8 ??m. 4.3.2 Hardness
The hardness of cutting blade shall not be less than 377 HV0.2.
4.3.3 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 0149-2006.
4.4 Service performance
4.4.1 Cutting performance
Disposable cut of the umbilical cord shall have good cutting performance. 4.4.2 Clamping performance
Disposable cut of the umbilical cord shall have good clamping performance, which shall be capable of bearing a 15 N static load.
4.4.3 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
If disposable cut of the umbilical cord is sterilized using ethylene oxide, the residue of ethylene oxide shall not be greater than 10 ??g/g.
4.7 Biological evaluation
4.7.1 In vitro cytotoxicity
The cytotoxic reaction of disposable cut of the umbilical cord shall not be greater than grade 2.
4.7.2 Delayed-type hypersensitivity
Disposable cut of the umbilical cord shall not cause delayed-type hypersensitivity. 4.7.3 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 1.0.
5 Test methods
5.1 Appearance
5.1.1 Use normal or corrected visual acuity to check and use hand to feel. It shall be as specified in 4.1.1.
5.1.2 Use normal or corrected visual acuity to check. It shall be as specified in 4.1.2. 5.2 Dimensions
Use general measuring tools for measurement. They shall be as specified in 4.2. 5.3 Cutting blade
5.3.1 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 4.3.1.
5.3.2 Hardness
Conduct test using the method specified in GB/T 4340.1-2009. It shall be as specified in 4.3.2.
5.3.3 Corrosion resistance
Conduct test using the boiling method specified in YY/T 0149-2006. It shall be as specified in 4.3.3.
5.4 Service performance
5.4.1 Cutting performance
Use the infusion tube 5 mm ?? 7 mm specified in Table 1 of YY/T 0031-2008; 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 4.4.1.
5.4.2 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 4.4.2. 5.4.3 Fitting performance
Simulate the shearing (cutting) movement; and clamp the umbilical cord before the infusion tube specified in 5.4.1 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 4.4.3.
5.5 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 4.5. 5.6 Ethylene oxide residue
Conduct test using the ethylene oxide residue test method specified in GB/T 14233.1- 2008. It shall be as specified in 4.6.
5.7 Biological evaluation
5.7.1 In vitro cytotoxicity
Conduct test using the method specified in 8.2 (the extract liquid test) of GB/T 16886.5- 2003.
5.7.2 Delayed-type hypersensitivity
Conduct test using the method specified in 7.4 (the maximum dose test) of GB/T 16886.10-2005. It shall be as specified in 4.7.2.
5.7.3 Intradermal reaction
Conduct test using the method specified in Annex B.2 (the intradermal reaction test) of GB/T 16886.10-2005. It shall be as specified in 4.7.3.
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
6.3.1 Batch-by-batch inspection is conducted as specified in GB/T 2828.1. 6.3.2 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).
Table 2 ?€? Batch-by-batch inspection
Nonconformity
classification Category A Category B Category C
Inspection group I I I
Inspection items 4.5, 4.6 4.3, 4.4 4.1, 4.2
Inspection level - S-2 S-3
Acceptable quality limit
(AQL) All pass inspection 4.0 6.5
6.4 Periodic inspection
6.4.1 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. 6.4.2 Periodic inspection shall be conducted as specified in GB/T 2829. 6.4.3 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).
Table 3 ?€? Periodic inspection
Nonconformity
classification Category A Category B Category C
Inspection group I I I
Inspection items 4.5, 4.6, 4.7 4.3, 4.4 4.1, 4.2
Inspection level I
Rejectable quality limit
(RQL) All pass inspection 30 50
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 16886.1, 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
7.1.1 Product marking
Each disposable cut of the umbilical cord shall be provided with company code or trademark.
7.1.2 Single package marking
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.
7.1.3 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.
7.1.4 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.
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
8.1.1 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.
8.1.2 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.

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