ISO 11193-2:2006

Single-use medical examination gloves — Part 2: Specification for gloves made from poly(vinyl chloride)

ISO 11193-2:2006 specifies requirements for packaged sterile, or bulked non-sterile, poly(vinyl chloride) gloves intended for use in medical examinations, and diagnostic or therapeutic procedures, to protect the patient and the user from cross-contamination. It also covers poly(vinyl chloride) gloves intended for use in handling contaminated medical materials. ISO 11193-2:2006 is intended as a reference for the performance and safety of poly(vinyl chloride) examination gloves. The safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and storage procedures are outside the scope of ISO 11193-2:2006.

Gants en caoutchouc pour examen médical, non réutilisables — Partie 2: Spécifications pour gants fabriqués en chlorure de polyvinyle

General Information

• Status: Published
• Publication Date: 24-Oct-2006
• ICS: 11.140 - Hospital equipment
• ICS: 83.140.99 - Other rubber and plastics products
• Technical Committee: ISO/TC 45/SC 4 - Products (other than hoses)
• Drafting Committee: ISO/TC 45/SC 4/WG 5 - Gloves and other latex products
• Current Stage: 9092 - International Standard to be revised
• Completion Date: 01-Nov-2021

Relations

• Revises: ISO 11193:1994 - Single-use rubber examination gloves — Specification
• Effective Date: 15-Apr-2008

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 11193-2
First edition
2006-11-01


Single-use medical examination gloves —
Part 2:
Specification for gloves made from
poly(vinyl chloride)
Gants en caoutchouc pour examen médical, non réutilisables —
Partie 2: Spécifications pour gants fabriqués en chlorure de polyvinyle





Reference number
ISO 11193-2:2006(E)
©
ISO 2006

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ISO 11193-2:2006(E)
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ii © ISO 2006 – All rights reserved

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ISO 11193-2:2006(E)
Contents Page
Foreword. iv
1 Scope . 1
2 Normative references . 1
3 Classification. 2
4 Materials . 2
5 Sampling and selection of test pieces. 2
6 Requirements . 3
7 Packaging . 4
8 Marking . 4
Annex A (normative) Test for watertightness . 8

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ISO 11193-2:2006(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 2.
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 document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11193-2 was prepared by Technical Committee ISO/TC 45, Rubber and rubber products, Subcommittee
SC 4, Products (other than hoses).
This part of ISO 11193, together with ISO 11193-2, cancels and replaces ISO 11193:1994, which has been
technically revised.
ISO 11193 consists of the following parts, under the general title Single-use medical examination gloves:
— Part 1: Specification for gloves made from rubber latex or rubber solution
— Part 2: Specification for gloves made from poly(vinyl chloride)

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INTERNATIONAL STANDARD ISO 11193-2:2006(E)

Single-use medical examination gloves —
Part 2:
Specification for gloves made from poly(vinyl chloride)
WARNING — Persons using this International Standard should be familiar with normal laboratory
practices. This standard does not purport to address all of the safety problems, if any, associated with
its use. It is the responsibility of the user to establish appropriate safety and health practices and to
ensure compliance with any regulatory conditions.
1 Scope
This part of ISO 11193 specifies requirements for packaged sterile, or bulked non-sterile, poly(vinyl chloride)
gloves intended for use in medical examinations, and diagnostic or therapeutic procedures, to protect the
patient and the user from cross-contamination. It also covers poly(vinyl chloride) gloves intended for use in
handling contaminated medical materials.
This part of ISO 11193 is intended as a reference for the performance and safety of poly(vinyl chloride)
examination gloves. The safe and proper usage of examination gloves and sterilization procedures with
subsequent handling, packaging and storage procedures are outside the scope of this part of ISO 11193.
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.
ISO 37:2005, Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
ISO 188, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
ISO 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
ISO 10993 (all parts), Biological evaluation of medical devices
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
ISO 23529, Rubber — General procedures for preparing and conditioning test pieces for physical test
methods
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ISO 11193-2:2006(E)
3 Classification
Gloves are classified by finish as follows:
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 plasticized poly(vinyl chloride). To facilitate donning the gloves, any
surface treatment, lubricant, powder or polymer coating may be used.
Any pigment, surface treatment, lubricant, or powder used shall be non-toxic and shall be disclosed on
request. 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, on request, data to support compliance with these requirements.
NOTE Limits of extractable plasticizers, residual chemicals and residual powder in gloves may be specified in future
editions of this part of ISO 11193, subject to the availability of relevant ISO standard test methods.
5 Sampling and selection of test pieces
5.1 Sampling
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.
When a lot size cannot be determined, a lot of 35 001 to 150 000 shall be assumed.
Table 1 — Inspection levels and AQLs
Characteristic Inspection level AQL
Physical dimensions (width, length, thickness) S-2 4,0
Watertightness G-1 2,5
Force
...