ISO 10282:2002
(Main)Single-use sterile rubber surgical gloves — Specification
Single-use sterile rubber surgical gloves — Specification
ISO 10282:2002 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 International Standard.
Gants en caoutchouc à usage chirurgical, stériles, non réutilisables — Spécifications
General Information
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 10282
Second edition
2002-09-15
Single-use sterile rubber surgical gloves —
Specification
Gants en caoutchouc à usage chirurgical, stériles, non réutilisables —
Spécifications
Reference number
ISO 10282:2002(E)
©
ISO 2002
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ISO 10282:2002(E)
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ii © ISO 2002 – All rights reserved
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ISO 10282:2002(E)
Contents Page
Foreword . iv
1 Scope. 1
2 Normative references. 1
3 Classification. 1
4 Materials. 2
5 Sampling and selection of test pieces. 3
6 Requirements. 3
7 Packaging. 6
8 Marking. 6
Annex A (normative) Test for watertightness. 8
© ISO 2002 – All rights reserved iii
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ISO 10282:2002(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
The main task of technical committees is to prepare International Standards. Draft International Standards adopted
by the technical committees are circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10282 was prepared by Technical Committee ISO/TC 45, Rubber and rubber products, Subcommittee SC 4,
Products (other than hoses).
This second edition cancels and replaces the first edition (ISO 10282:1994), which has been technically revised.
Annex A forms a normative part of this International Standard.
iv © ISO 2002 – All rights reserved
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INTERNATIONAL STANDARD ISO 10282:2002(E)
Single-use sterile rubber surgical gloves — Specification
1 Scope
This International 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 International Standard.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 37:1994, Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
ISO 188:1998, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
ISO 2859-1:1999, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
ISO 4648:1991, Rubber, vulcanized or thermoplastic — Determination of dimensions of test pieces and products
for test purposes
ISO 10993 (all parts), Biological evaluation of medical devices
ISO 15223:2000, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied
3 Classification
3.1 General
Gloves are classified by type, design and finish, as given in 3.2 to 3.4.
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ISO 10282:2002(E)
3.2 Type
Two types are classified:
a) type 1: gloves made primarily from natural rubber latex;
b) type 2: gloves made primarily from nitrile rubber latex, polychloroprene rubber latex, styrene-butadiene rubber
solution, styrene-butadiene rubber emulsion or thermoplastic elastomer solution.
3.3 Design
Two designs are classified:
a) gloves with straight fingers;
b) gloves with fingers curved in the palmar direction.
The glove shall be anatomically correct, with the thumb positioned towards the palmar surface of the index finger
rather than lying flat. The fingers and thumb may be straight or curved in the palmar direction.
3.4 Finish
Four finishes are classified:
a) textured surface over part or all of the glove;
b) smooth surface;
c) powdered surface;
d) powder-free surface.
NOTE 1 Powdered gloves are gloves where a powder has been added as a part of the manufacturing process, generally to
facilitate donning. Powder-free gloves are gloves which have been manufactured without the deliberate addition of powdered
materials to facilitate donning.
NOTE 2 The cuff termination of the glove may be cut or in the form of a rolled rim.
4 Materials
Gloves shall be manufactured from compounded natural rubber or nitrile 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.
Any pigment used shall be non-toxic. It is essential that substances used for surface treatment which are capable
of being transferred are bio-absorbable.
Gloves as supplied to the user shall comply with the relevant part(s) of ISO 10993. The manufacturer shall make
available to the purchaser, on request, data to support compliance with these requirements.
NOTE 1 Other suitable polymeric materials may be included in future editions of this International Standard.
NOTE 2 It is recognized that some individuals may, over a period of time, become sensitized to a particular rubber
compound (allergic reaction) and require gloves of an alternative formulation.
NOTE 3 Limits of extractable proteins, allergenic proteins, residual chemicals, endotoxins and residual po
...
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