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[GB/T 24787-2009] Single-use non-sterile rubber surgical gloves
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GB 24787-2009
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PDF similar to GB 24787-2009
Standard similar to GB 24787-2009 GB 24788 GB 24786 GB 24788 Basic data | Standard ID | GB 24787-2009 (GB24787-2009) | | Description (Translated English) | [GB/T 24787-2009] Single-use non-sterile rubber surgical gloves | | Sector / Industry | National Standard | | Classification of Chinese Standard | G45 | | Classification of International Standard | 11.140 | | Word Count Estimation | 10,129 | | Date of Issue | 2009-12-15 | | Date of Implementation | 2010-10-01 | | Quoted Standard | GB/T 528; GB/T 2941; GB/T 2828.1; GB/T 3512; GB/T 16886 (all); YY 0466-2003 | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 15 of 2009 (total 155) | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This Chinese standard specifies the use of non- sterile disposable rubber gloves, surgical performance, safety and technical requirements. This standard applies to surgical procedures to prevent cross-infection of patients and users are packaged non-sterile rubber surgical gloves. But gloves storage, security, proper use, sterilization and subsequent processing is not applicable to this standard. | GB 24787-2009: [GB/T 24787-2009] Single-use non-sterile rubber surgical gloves---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Single-use non-sterile rubber surgical gloves
ICS 11.140
G45
National Standards of People's Republic of China
Disposable non-sterile rubber surgical gloves
Posted 2009-12-15
2010-10-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Foreword
6.1,6.2,6.3 this standard is mandatory, the rest are recommended.
Appendix A of this standard is a normative appendix.
The standard proposed by China Petroleum and Chemical Industry Association.
This standard by the National Rubber and rubber products latex products Standardization Technical Committee Technical Committee (SAC/TC35/SC4)
Centralized.
This standard is mainly drafted by. Guilin Latex Factory, Zhanjiang Exit Inspection and Quarantine, China Rubber Group Zhuzhou Rubber Plastic Industry Research and Design
Hospital, Ansell health products company, Qingdao Latex Products Co. together.
The main drafters of this standard. Liu Bin, CSL, Deng Zhi, Xiao Lian, Zhao Jinxiang.
Disposable non-sterile rubber surgical gloves
1 Scope
This standard specifies the use of non-sterile disposable surgical rubber glove performance, safety and technical requirements.
This standard applies to surgical procedures to prevent cross-infection of patients and users of packaged non-sterile rubber surgical gloves. But Gloves
Storage, safety, proper use, and subsequent sterilization process does not apply to this standard.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/T 528 Determination of vulcanized rubber or thermoplastic rubber tensile stress-strain properties
GB/T 2941 rubber physical test method for preparing and conditioning General Procedure
GB/T 2828.1 Sampling procedures for inspection - Part 1. by acceptance quality limit (AQL) retrieval batch inspection sampling plan
GB/T 3512 vulcanized rubber or thermoplastic rubber hot air and heat accelerated aging test
Biological evaluation of GB/T 16886 (all parts) Medical Devices
Symbol YY0466-2003 medical equipment used with medical device labels, labeling and information provided
Category 3
3.1 General
Gloves to type, design, surface type, attachment type classification.
3.2 Types
It can be divided into two types.
Type 1. manufactured from natural rubber latex gloves.
Type 2. chloroprene rubber latex, styrene-butadiene rubber solution or emulsion, solution or emulsion of the thermoplastic elastomer gloves made.
Note. the type 1 and type 2 mixed or composite material manufactured gloves 3 gloves.
3.3 Design
According to the design of two types.
Straight type (R type). upright gloves with fingers, except the thumb, the palm and the other four fingers substantially in the same plane.
Curved (C-type). All or part of the glove finger is bent, with the palm of each finger not on the same plane.
Gloves meet the physical structure, that is where the thumb is located in front of the palm side of the index finger and not in the same plane, left and right points. Thumb and
Other fingers may be flat or curved surface of the palm.
3.4 Surface Type
By product type surface film of two types.
Pock (T type). Gloves all or part of the surface of a pattern or roughening.
Smooth (S type). smooth surface.
3.5 attachment type
Product type attached to the surface by three types.
Powdered (P-type). Gloves powder-coated surface.
No powder (F-type). surface with the inner glove chlorination or other methods to no powder.
Coating (C type). the polymer surface coating material or other non-isolated powder lubricant agent.
Note 1. Powdered gloves are powder was added in the glove manufacturing process, usually in order to facilitate wear. Powder-free gloves is not another in the glove manufacturing process
Outside the powder material is added to facilitate wear.
Note 2. The cuff end may be cut or curled.
Note 3. For example, the natural rubber latex and a surface with a pattern of finger-shaped for straight powder-free gloves can be expressed as "1-RTF".
4 Materials
Gloves are made with natural rubber latex, chloroprene rubber latex with, or styrene-butadiene rubber or a thermoplastic elastomer with solution or emulsion, or
Made with styrene-butadiene rubber latex. In order to facilitate gloving, any line with GB/T 16886 requirements lubricant or polymeric powder
Was coated was subjected to a surface treatment.
Any pigment used should be non-toxic. Substances used for surface treatment should be movable bioabsorbable.
Gloves should be provided to the user to meet the requirements GB/T 16886 relevant portion. When necessary, the manufacturer should be made accessible symbol buyers
Fulfills these requirements information.
Note 1. Other suitable polymeric materials may be included in future versions of the standard.
Note 2. Gloves soluble protein, allergenic proteins, residual chemicals, endotoxins and limited residual powder can be found in later versions of this standard
It can be specified, and comply with limits related substances.
5 Sampling and test piece selection
5.1 Sampling
Gloves should be GB/T 2828.1 sampling and inspection. Check the level and acceptance quality limit (AQL) shall comply with the requirements in Table 1.
When the batch size can not be determined, it should be assumed in quantities of 35,001 to 150,000.
Table 1 Check the level and acceptance quality limit (AQL)
Characteristic inspection level AQL
Physical dimensions (length, width, thickness) S-2 4.0
Impermeability Ⅰ 1.5
Tensile strength and elongation at break (before aging, post) and 300% elongation load (before aging) S-2 4.0
5.2 test piece selection
Specimen shall glove palm or back along the dipping direction and cut gloves.
6 Requirements
6.1 Dimensions
When measured according to the position shown in Figure 1, the glove palm width and length shall conform to Table 2, the level of inspection and acceptance quality limit (AQL) Press
Specified in Table 1.
Length should be the shortest distance from the tip of the middle finger to the cuff edge.
Note. Length measurements can also be hung on the glove radius measured on 5mm suitable rod.
Width is measured at the root of the index finger to thumb root midpoint position measurement. When measuring, gloves should be flat.
Gloves double thickness measurements should be consistent with the provisions of GB/T 2941, and having 22kPa ± 5kPa measuring foot pressure thickness gauge,
In each position measurement shown in FIG. 2, namely. from the middle to the top 13mm ± 3mm at the location and distance of approximately palm cuff edge
At 25mm ± 5mm. Half measured in terms of a double thickness of layer thickness, and should meet the size requirements of Table 2. Check the level and the ground
Receive quality limit (AQL) shall comply with the requirements of Table 1.
If visual examination revealed the presence of a thin point, layer thickness should be measured in these thin POSITION. Smooth surface portion and the portion of the single hemp
When the layer thickness measurement by this provision shall not be less than 0.10mm and 0.13mm, respectively.
NOTE. According to GB/T 5723 measuring cuff edge thickness is preferably not more than 2.50mm.
1 width and length measurement position of FIG.
Table 2 Dimensions and Tolerances
Size Code
Width/mm
(Figure 1 size)
Minimum length/mm
Minimum thickness/mm
(The position shown in FIG. 2)
5 67 ± 4 250
5.5 72 ± 4 250
6 77 ± 5 260
6.5 83 ± 5 260
7 89 ± 5 270
7.5 95 ± 5 270
8 102 ± 6 270
8.5 108 ± 6 280
9 114 ± 6 280
9.5 121 ± 6 280
For all sizes.
Smooth. 0.10
Pock. 0.13
Millimeters
Note. For different sizes of gloves, 48mm ± 9mm location at about the center of the palm.
2 for measuring the thickness map
6.2 impermeability
When the gloves were not in accordance with Appendix A permeability test, the sample size and allowable failure (leakage) the number of gloves, should be in accordance with Table 1
The level of inspection and acceptance quality limit (AQL) is determined.
6.3 Tensile Properties
6.3.1 Overview
Tensile properties according to GB/T 528 was measured. And cut three test pieces, the test results taken from the value of each glove. Gloves should test pieces
Palm or back along the dipping direction and cut gloves.
6.3.2 300% elongation before aging load, tensile strength and elongation at break
When measured by the method of GB/T 528 provisions, the use of type 2 dumbbell specimen, tensile strength, elongation at 300% load and elongation at break shall comply
Fit the requirements of Table 3. Check the level and acceptance quality limit (AQL) shall comply with the requirements in Table 1.
6.3.3 aging tearing and elongation at break
Aging test method according to GB/T 3512 will be prescribed. After from 70 ℃ ± 2 ℃, and cut the 168h ± 2h after aging gloves
The test piece, its tearing and elongation at break shall comply with the requirements of Table 3, the level of inspection and acceptance quality limit (AQL) shall comply with the requirements in Table 1.
Table 3 Tensile Properties
performance
Claim
Type 1 Type 2
Minimum force at break before aging/N 12.5 9.0
Before aging Elongation at break min /% 700 600
Before aging 300% elongation maximum load/N 2.0 3.0
Minimum force at break after aging/N 9.5 9.0
Elongation at break after aging min /% 550 500
NOTE. Type 3 Type 1 reference gloves gloves.
6.4 Eligible determination
When the test results does not exceed the predetermined table reception quality limit (AQL), gloves can be considered in line with the requirements of this standard; if a test result
When the item exceeds specified in Table 1. acceptance quality limit (AQL), the project may fail according to GB/T 2828.1 were tightened inspections. If still
Qualified, then this batch of product failure.
7 Packaging
Gloves should be placed in suitable packaging.
8 flag
8.1 Overview
The marking shall include the terms of this standard, YY0466-2003 available the appropriate symbol on the label.
Language for flags shall seek consensus stakeholders.
8.2 Packaging Unit
Each unit of packaging, outer packaging should be clearly marked with the following.
a) the name or trademark of the manufacturer or supplier;
b) use of materials;
c) "straight" or "curved" or glove design content expressed similar words;
d) "Pock" or "smooth", "Powdered" or "powder-free" or similar words glove types are described;
e) Dimensions;
f) for a manufacturer identification lot number;
g) "date of manufacture" or similar words, the year (four digits) and month of manufacture;
h) the words "non-sterile" in;
i) the words "before using the medical device sterilization procedures should be sterilized" in;
j) the words "one use";
k) the words "rubber surgical gloves" in;
l) for type 1 gloves, labeled products the words "by the manufacturer may cause allergic reactions to natural rubber latex," or words of similar description.
More than 8.3 units of packaging
Multi-unit package that is pre-determined number of units of the same size glove box packaging a product, the purpose is to facilitate the safe transport and storage
Deposit. Multi-unit package according to 8.2a) ~ 8.2h) and 8.2j) to be labeled and marked number.
Appendix A
(Normative)
Watertight test
A. 1 device
A. 1.1 cylinder barrel
The minimum diameter of 60mm, and is fixed to the glove size sufficient for the above, and can accommodate 1000mL of water, as shown in Figure A. 1 FIG.
Note. The cylinder barrel is preferably transparent.
A. 1.2 water-filled device
Make gloves remain vertical when filled with water. As shown in Figure A. Fig.
A. 1.3 cylindrical cup
Volume of at least 1000mL, a performance or other transfer of 1000mL water means.
A. Step 2
By suitable means, such as O-rings, the glove is fixed to the cylinder barrel, so that the glove does not exceed the cylinder barrel 40mm.
Import 1000mL ± 50mL, does not exceed 36 ℃ of water to the device, wipe away any water splashed on the gloves. If the water can not be raised
40mm from the edge of the sleeve, so that the entire glove hold gloves cuff section 40mm from outside can be filled with water. Now pay attention to any apparent
leakage. If the glove does not leak immediately, and then observed 2min ~ 4min. Ignore leakage from the sleeve edges within 40mm. For ease of observation,
Water soluble dyes for staining.
Millimeters
1 --- hook;
2 --- cylinder;
3 --- engraved lines the inside surface of the cylinder.
Figure A. 1 cylinder barrel
Figure A. 2 fixtures
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