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GB 10213-2006 English PDF

GB 10213-2006_English: PDF (GB10213-2006)
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GB 10213-2006English85 Add to Cart 0--9 seconds. Auto-delivery Single-use medical rubber examination gloves Valid GB 10213-2006
Standards related to: GB 10213-2006

BASIC DATA
Standard ID GB 10213-2006 (GB10213-2006)
Description (Translated English) Single-use medical rubber examination gloves
Sector / Industry National Standard
Classification of Chinese Standard G44
Classification of International Standard 83.140
Word Count Estimation 10,128
Date of Issue 2006-03-14
Date of Implementation 2006-12-01
Older Standard (superseded by this standard) GB 10213-1995
Quoted Standard GB/T 2828.1; YY 0466; ISO 37; ISO 188; ISO 4648
Adopted Standard ISO 11193.1-2002, IDT
Drafting Organization China Rubber Group Zhuzhou Rubber Plastics Industry Research and Design Institute
Administrative Organization National Rubber and rubber products rubber Dairy Standardization Technical Committee Technical Committee
Regulation (derived from) China Announcement of Newly Approved National Standards No. 9, 2006 (No. 96 overall)
Proposing organization China Petroleum and Chemical Industry Association
Issuing agency(ies) Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China
Summary This Chinese standard specifies the sterile or non- sterile, as a medical examination and diagnosis and treatment process to prevent cross-infection between patients and users of rubber examination gloves requirements, but also for the treatment of contaminated medical materials, rubber examination gloves. Glove surface is glossy or linen surface. This standard specifies the rubber examination gloves, performance and safety requirements, but the safety of examination gloves, proper use and sterilization process and subsequent handling and storage process is not within the scope of this standard.

GB 10213-2006 ICS 83.140 G 44 GB National Standard of the People’s Republic of China GB 10213-2006 / ISO 11193.1.2002 Replacing GB 10213-1995 Single-use medical rubber examination gloves (ISO 11193.1.2002 Single-use medical rubber examination gloves - Part 1. Specification for gloves made from rubber latex or rubber solution, IDT) ISSUED ON. MARCH 14, 2006 IMPLEMENTED ON. DECEMBER 1, 2006 Issued by. General Administration of Quality Supervision, Inspection and Quarantine; Standardization Administration Committee. Table of Contents Foreword 3 1 Scope 5 2 Normative references .. 5 3 Classification 6 4 Materials 7 5 Sampling and selection of test pieces . 7 6 Requirements .. 8 7 Packaging 12 8 Signs .. 13 Appendix A 15 Foreword The content of Chapter 6 of this Standard is mandatory, the rest are recommended. This Standard is equivalent to adopt ISO 11193.1.2002 "Single-use rubber medical examination gloves - Part 1. Specification for gloves made from rubber latex or rubber solution" (English version). For ease of use, this Standard only makes editorial changes to ISO 11193.1.2002. This Standard replaces GB 10213-1995 "Single-use rubber examination gloves". This Standard is equivalent to translating ISO 11193.1.2002. The main differences between this Standard and GB 10213-1995 are as follows. - MODIFY the name of Standard; - ADD the content of glove classification (shown in Chapter 3); - ADD that the material making glove is synthetic rubber latex and solution (Chapter 3 of 1995-edition; Chapter 4 of this edition); - The inspection level of impermeability is revised from "S-4" to "G-I" (shown in Table 1); - The dimension of glove is revised from large, medium and small TO extra small, small, medium, large and extra large. ADD seven models of which the dimension codes are 6 and below, 6.5, 7, 7.5, 8, 8.5, 9 and above (shown in Table 2); - The original tensile strength is revised to be breaking tenacity. The requirements for different tensile property of different types of gloves are different (shown in Table 3). The Appendix A of this Standard is normative. This Standard was proposed by China Petroleum and Chemical Industry Association. This Standard shall be administrated by Technical Committee of Latex Products of National Standardization Technical Committee of Rubber and Rubber Products (SAC/TC 35/SC 4). Main drafting organization of this Standard. Zhuzhou Industry Research and Design Institute of Rubber & Plastics of China Rubber Group. Main drafter of this Standard. Zhao Ping. The previous versions replaced by this Standard are. - GB 10213-1988, GB 10213-1995. Single-use medical rubber examination gloves 1 Scope This Standard specifies the requirements for the rubber examination gloves that are sterilized or non-sterilized, and that are used to prevent cross-infection between patients and users in the process of medical examination and diagnostic treatment. It also includes rubber examination gloves used to process contaminated medical materials. The surface of glove is smooth or pitted. This Standard specifies the requirements for the property and safety of rubber examination gloves. However, the safety inspection, proper use, sterilization process, subsequent treatment, and storage process of gloves are not within the scope of this Standard. 2 Normative references The provisions in the following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Standard, however, parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies. GB/T 2828.1 Sampling procedures for inspection by attribute – Part 1. Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (GB/T 2828.1-2003, ISO 2859-1. 1999, IDT) YY 0466 Medical devices - Symbols to be used with medical device labels labeling and information to be supplied ISO 37 Rubber, vulcanized or thermoplastic - Determination of tensile 4 Materials The glove shall be made from compounding natural rubber latex, For ease of wearing, the surface can be treated with lubricant, powder or polymer covering that meet the requirements of ISO 10993. Any pigment used shall be nontoxic. The material used in surface treatment must be easy to move and bioabsorbable. The gloves provided to users shall meet the requirements of the relevant parts of ISO 10993. Note 1. Other suitable polymeric materials may be included in future versions of this Standard. Note 2. It is generally considered that. After a certain period of time, if some people are sensitive (allergic reaction) to some kinds of special rubber compounding agents, it is required to use the gloves with another recipe. Note 3. The limits of soluble protein, allergenic protein, residual chemicals, endotoxins and residual powder in gloves may be specified in future versions of this Standard. And it shall comply with the relevant test method standard. 5 Sampling and selection of test pieces 5.1 Sampling As acceptable use, the glove shall be conducted sampling and inspection according to the requirements of GB/T 2828.1. The inspection level and acceptance quality limit (AQL) value shall comply with the requirements of Table 1. When the size of batch amount can not be determined, it shall be assumed that the batch amount is 35 001~150 000. c) "Pitted surface" or "Smooth surface", "Powdered" or "Powder-free", or other words that have such effects on finished gloves; d) Dimension; e) The batch number by manufacturer identification; f) Words of "Single-use"; j) For Category 1 gloves, indicate that the products is "Made from natural rubber latex that may cause allergic reactions" or similar words. 8.3 Multi-unit packaging The multi-unit packaging is equivalent to a box of products of a unit packaging of same-size gloves of that the quantity is pre-determined. The purpose is to make it more convenient for transportation and storage. The multi-unit packaging shall be marked according to 8.2.1 or 8.1.2. And it shall indicate the number of gloves and additional storage instructions. Appendix A (Normative) Impermeability test A.1 Devices A.1.1 Cylinder The minimum diameter is 60mm. And it has sufficient length to fix the glove on it and accommodate 1000mL of water, as shown in Figure A.1. Note. The cylinder is better to be transparent. A.1.2 Water filling device It can make the glove keeping vertical when filling water, as shown in Figure A.2. A.1.3 Cylindrical measuring cup The volume is at least 1000mL or other devices that can transfer 1000mL of water at a time. A.2 Steps USE suitable device, such as O-ring, to bind the glove on the cylinder. So that the glove would not exceed 40mm from the cylinder. IMPORT 1000mL ± 50mL of water, of which the temperature does not exceed 36 ºC, into the device. WIPE away any water splashed on the glove. If the water can not rise to 40mm away from the sleeve edge, lift the glove to ensure the entire glove (including the part that is 40mm away from the sleeve edge) to be tested. NOTICE any significant leakage immediately. If there is no immediate leakage, then observe for 2min~4min. Ignore the leakage within 40mm from the sleeve edge. For ease of observation, it can use water-soluble ...