GB/T 7543-2020 PDF English
US$170.00 · In stock · Download in 9 secondsGB/T 7543-2020: Single-use sterile rubber surgical gloves Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid GB/T 7543: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB/T 7543-2020 | English | 170 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
Single-use sterile rubber surgical gloves
| Valid |
| GB 7543-2006 | English | 150 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
Single-use sterile rubber surgical gloves
| Obsolete |
| GB 7543-1996 | English | 359 |
Add to Cart
|
3 days
|
Rubber surgical gloves
| Obsolete |
| GB 7543-1987 | English | RFQ |
ASK
|
3 days
|
Rubber surgical gloves
| Obsolete |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: GB/T 7543-2020
GB/T 7543-2020: Single-use sterile rubber surgical gloves---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/GBT7543-2020
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 83.140.99;11.140
G 45
GB/T 7543-2020 / ISO 10282.2014
Replacing GB 7543-2006
Single-use sterile rubber surgical gloves
(ISO 10282.2014, Single-use sterile rubber surgical gloves - Specification,
IDT)
Issued on. DECEMBER 14, 2020
Implemented on. JULY 01, 2021
Issued by. State Administration for Market Regulation;
Standardization Administration of the People's Republic of China.
Table of Contents
Foreword... 3
1 Scope... 6
2 Normative references... 6
3 Classification... 6
4 Materials... 7
5 Sampling and selection of test pieces... 8
6 Requirements... 8
7 Packaging... 12
8 Marking... 12
Annex A (normative) Test for watertightness... 14
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard replaces GB 7543-2006 “Single-use sterile rubber surgical gloves -
Specification”. Compared with GB 7543-2006, in addition to the editorial
modifications, the main technical changes in this Standard are as follows.
- In the Scope, modified "This Standard specifies the technical requirements for
packaged sterile rubber gloves used in surgical procedures to protect the patient
and user and avoid cross-contamination. It is applicable to disposable gloves that
are worn once and then discarded. It is inapplicable to examination gloves or
procedure gloves. It includes gloves with smooth surfaces and gloves with hemp
surfaces. " TO “This Standard specifies requirements for packaged sterile rubber
gloves intended for use in surgical procedures to protect the patient and the user
from cross-contamination. It is applicable to single-use gloves that are worn once
and then discarded. It does not apply to examination or procedure gloves. It covers
gloves with smooth surfaces and gloves with textured surfaces over part or the
whole glove.” (see Chapter 1 of this Edition, Chapter 1 of Edition 2006);
- In 3.2 Type, modified "b) Type 2.gloves manufactured primarily from nitrile rubber
latex, neoprene latex, styrene-butadiene rubber latex, styrene-butadiene rubber
latex or thermoplastic elastomer solution." TO “b) Type 2.gloves made primarily
from nitrile rubber latex, isoprene rubber latex, polychloroprene rubber latex,
styrene-butadiene rubber solution, styrene-butadiene rubber emulsion or
thermoplastic elastomer solution.” (see 3.2 of this Edition, 3.2 of Edition 2006);
- in 3.4 Finish, modified "There are four types of finishes. a) pockmarked surface; b)
smooth surface; c) powdered surface; d) powder-free surface." TO “Two finishes
are classified. a) textured surface over part or all of the glove; b) smooth surface.”
(see 3.4 of this Edition, 3.4 of Edition 2006);
- in Chapter 4, modified "Gloves are made with natural rubber latex, nitrile rubber
latex, neoprene latex, styrene-butadiene rubber or thermoplastic elastomer
solution, or styrene-butadiene rubber latex. For ease of donning, surface treatment
with ISO 10993 compliant lubricants, powders or polymeric coatings may be
used.” TO “Gloves shall be manufactured from compounded natural rubber or
nitrile rubber or isoprene rubber or polychloroprene rubber latex, or compounded
styrene-butadiene rubber or thermoplastic elastomer solution, or compounded
styrene-butadiene rubber emulsion. To facilitate donning the gloves, any surface
treatment, lubricant, powder or polymer coating may be used subject to
compliance with ISO 10993.” (see Chapter 4 of this Edition, Chapter 4 of Edition
2006);
- in 6.3.1, modified "Tensile properties shall be determined in accordance with ISO
37.Cut 3 test pieces from each glove. The result is the median value. The test
piece should be taken from the palm or back of the glove.” TO “Tensile properties
shall be measured in accordance with ISO 37, taking three type 2 dumb-bell test
pieces from each glove and using the median value as the test result. Test pieces
shall be taken from the palm or back of gloves.” (see 6.3.1 of this Edition, 6.3.1
of Edition 2006).
This Standard uses translation method to identically adopt ISO 10282.2014 “Single-use
sterile rubber surgical gloves - Specification”.
The Chinese documents which have consistency with the international normative
references in this Standard are as follows.
- GB/T 528-2009, Rubber, vulcanized or thermoplastic - Determination of tensile
stress-strain properties (ISO 37.2005, IDT)
- GB/T 2828.1-2012, Sampling procedures for inspection by attributea-Part1.
Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot
inspection (ISO 2859-1.1999, IDT)
- GB/T 2941-2006, Rubber - General procedures for preparing and conditioning test
pieces for physical test methods (ISO 23529.2004, IDT)
- GB/T 3512-2014, Rubber, vulcanized or thermoplastic - Accelerated ageing and
heat resistance tests (ISO 188.2011, IDT)
- GB/T 16886 (all parts), Biological evaluation of medical devices [ISO 10993(all
parts)]
- YY/T 0466.1-2016, Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1.General requirements
(ISO 15223.2012, IDT)
This Standard was proposed by China Petroleum and Chemical Industry Federation.
This Standard shall be under the jurisdiction of National Technical Committee on
Rubber and Rubber Products of Standardization Administration of China (SAC/TC 35).
The drafting organizations of this Standard. Shanghai Kebang Medical Latex
Equipment Co., Ltd., Medikang Medical Products Trading (Shanghai) Co., Ltd., Anhui
Hejia Medical Products Technology Co., Ltd., Guilin Zizhu Latex Products Co., Ltd.,
Xishuangbanna Yunmeng Xinxing Natural Rubber Co., Ltd., Shanghai Zhimei Rubber
Co., Ltd., Shanghai Huaxin Medical Materials Co., Ltd., Huaxin Medical Materials
(Anhui) Co., Ltd., Anhui Food and Drug Inspection and Research Institute, National
Health Commission Science and Technology Research Institute, National Latex
Product Quality Supervision and Inspection Center, Anhui Zhongzhike Standardization
Institute Co., Ltd., Blue Sail Medical Co., Ltd., Xinjiang Uygur Autonomous Region
Drug Inspection and Research Institute, Jiangxi Hengsheng Industrial Co., Ltd.,
Shaanxi Provincial Medical Device Quality Supervision and Inspection Institute,
Dongguan Jingan New Materials Co., Ltd., Guangdong Shunde Chuangke Testing
Technology Co., Ltd. Company, China National Chemical Zhuzhou Rubber Research
and Design Institute Co., Ltd.
Main drafters of this Standard. Zhu Xiaohua, Fan Yao, Hu Jun, Luo Jinhui, Zhang
Bohou, Ma Jinfeng, Jiang Jiming, Liu Junqiang, Li Jianbin, Wu Yebin, Zheng Tiankun,
Zheng Kaiwen, Zheng Kaiyuan, Huang Baohua, Ning Lifeng, Li Peng, Tan Yunhua,
Cui Congjun, Liu Wenjing, Liu Wei, Zhu Yizhong, Mei Wenbin, Zhang Cheng, Huang
Weihua, Zhang Jianxin, Deng Yizhi, Wang Jinying.
Versions of standard substituted by this Standard are.
- GB 7543-1987, GB 7543-1996, GB 7543-2006.
Single-use sterile rubber surgical gloves
1 Scope
This Standard specifies requirements for packaged sterile rubber gloves intended for
use in surgical procedures to protect the patient and the user from cross-contamination.
It is applicable to single-use gloves that are worn once and then discarded. It does not
apply to examination or procedure gloves.
2 Normative references
The 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.
3 Classification
Two types are classified.
4 Materials
Gloves shall be manufactured from compounded natural rubber or nitrile rubber or
isoprene rubber or polychloroprene rubber latex, or compounded styrene-butadiene
rubber or thermoplastic elastomer solution, or compounded styrene-butadiene rubber
emulsion. To facilitate donning the gloves, any surface treatment, lubricant, powder or
polymer coating may be used subject to compliance with ISO 10993.
5 Sampling and selection of test pieces
For reference purposes, gloves shall be sampled and inspected in accordance with ISO
2859-1.The inspection levels and acceptance quality limits (AQLs) shall conform to
those specified in Table 1 for the characteristics listed.
6 Requirements
The measurement of width shall be at the midpoint between the base of the index finger
and the base of the thumb. The width measurement shall be made with the glove placed
on a flat surface.
7 Packaging
Gloves shall be packaged in sequential two-layered packaging.
8 Marking
The outer wrapping for each unit pair of gloves shall be clearly marked with the
following.
A multi-unit package is one containing a predetermined number of unit packs of the
same glove size, intended to facilitate safe transport and storage.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
Tips & Frequently Asked QuestionsQuestion 1: How long will the true-PDF of English version of GB/T 7543-2020 be delivered?Answer: The full copy PDF of English version of GB/T 7543-2020 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 GB/T 7543-2020_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 7543-2020_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. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- GB/T 7543-2020 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds. Question 5: Should I purchase the latest version GB/T 7543-2020?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 7543-2020 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. How to buy and download a true PDF of English version of GB/T 7543-2020?A step-by-step guide to download PDF of GB/T 7543-2020_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "GB/T 7543-2020".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9
|