GB 7543-2006 English PDF (GB7543-2006)

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GB 7543-2006: Single-use sterile rubber surgical gloves
GB 7543-2006
Single-use sterile rubber surgical gloves
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.140
G 45
Replacing GB 7543-1996
(ISO 10282.2002, Single-Use Sterile
Rubber Surgical Gloves – Specification, IDT)
Issued on. March 14, 2006 Implemented on. December 01, 2006
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of PRC.
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 ...11
8 Marking ...11
Annex A (Normative) Test for Water Tightness ...14
Foreword
The Clause 6 in this Standard is mandatory, while the rest are recommended.
This Standard equivalently adopts ISO 10282-2002 Single-Use Sterile Rubber
Surgical Gloves – Specification (English Version).
This Standard equivalently translates ISO 10282.2002.
For the benefit of use, this Standard only makes the editorial modifications against the
ISO 10282.2002.
This Standard replaces GB 7543-1996 Rubber Surgical Gloves.
Compared with GB 7543-1996, this Standard has the major changes as follows.
--- Modify the standard name;
--- Modify the applicable scope from reusable to single-use (see Clause 1 of this
Edition);
--- Delete the performance requirements after cooking and aging (see 6.3 of Edition
1996);
--- Delete the conductivity test (see Annex B of Edition 1996);
--- Modify the impermeability from the original Inspection Level S-4 to the general
Inspection Level I (see 8.2 of Edition 1996; 5.1 of this Edition);
--- Modify the tensile strength and 300% stress at definite elongation into tear force
and 300% load at certain elongation (see 6.3 of this Edition);
--- In the aging test, modify the test piece aging into perform aging against the glove,
then cut into sample to take the test (see 7.3.2 of Edition 1996; 6.3.3 of this
Edition);
--- Increase the materials for processing gloves. synthetic rubber emulsion and
synthetic rubber solution (see Clause 4 of this Edition);
--- Add the gloves classification (see Clause 3); the tensile properties are different
due to the difference of the types (see 6.3.4 of this Edition);
--- The glove size is increased from the original 6 types (6 6.5 8 8.5) to 10 types
(5 5.5 6 8.5 9 9.5) (see 9.2 of Edition 1996; 6.1 of this Edition).
The Annex A of this Standard is normative.
This Standard was proposed by China Petroleum and Chemical Industry Association.
This Standard shall be under the jurisdiction of Latex Products Subcommittee of the
National Technical Committee for Standardization of Rubber and Rubber Products
(SAC/TC 35/SC 4).
Drafting organization of this Standard. Zhongxiang Group Zhuzhou Rubber Plastic
Industrial Research Institute.
Participating drafting organizations of this Standard. CFDA-Jinan Quality Supervision
and Inspection Center for Medical Devices, and Anhui Zhongjian Plastic and Rubber
Products Co., Ltd.
Chief drafting staffs of this Standard. Zheng Sanyang, Wu Ping, and Geng Jiwen.
The historical editions replaced by this Standard are as follows.
--- GB 7543-1987, GB 7543-1996.
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.It covers gloves with smooth surfaces and
gloves with textured surfaces over part or all of the glove.
This standard is intended as a reference for the performance and safety of rubber
surgical gloves.The safe and proper usage of surgical gloves and sterilization
procedures with subsequent handling, packaging and storage procedures are outside
the scope of this Standard.
2 Normative References
The provisions in following documents become the provisions of this Standard through
reference in this Standard.For dated references, the subsequent amendments
(excluding corrigendum) 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
Labelling and Information to be Supplied
ISO 37 Rubber, Vulcanized or Thermoplastic - Determination of Tensile Stress-
Strain Properties
ISO 188 Rubber, Vulcanized or Thermoplastic - Accelerated Ageing and Heat
Resistance Tests
ISO 4648 Rubber, Vulcanized or Thermoplastic - Determination of Dimensions of
Test Pieces and Products for Test Purposes
ISO 10993 (all parts) Biological Evaluation of Medical Devices