ISO 8009:2004

INTERNATIONAL ISO
STANDARD 8009
First edition
2004-10-01
Mechanical contraceptives — Reusable
natural and silicone rubber contraceptive
diaphragms — Requirements and tests
Contraceptifs mécaniques — Diaphragmes contraceptifs réutilisables
en caoutchouc — Performances et essais

Reference number
©
ISO 2004
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

©  ISO 2004
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2004 – All rights reserved

Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
4 Sampling . 2
5 Classification. 2
6 Materials. 2
7 Design . 2
7.1 General. 2
7.2 Rim. 2
7.3 Reinforcing spring . 2
7.4 Spring ends . 2
7.5 Dome and rim . 3
8 Dimensions. 3
8.1 Diameter. 3
8.2 Dome thickness. 3
9 Tensile properties of the dome. 3
9.1 Tensile strength . 3
9.2 Elongation at break. 3
10 Type 1 and Type 2 diaphragms — Mechanical properties of rim and spring . 4
10.1 Compression resistance . 4
10.2 Twisting during compression. 4
11 Freedom from visible defects . 4
12 Test report. 5
13 Packaging, labelling and storage . 5
13.1 Packaging . 5
13.2 Labelling. 5
13.3 Storage. 6
Annex A (normative) Determination of size. 7
Annex B (normative) Determination of dome thickness . 8
Annex C (normative) Determination of tensile properties . 9
Annex D (normative) Determination of deterioration after accelerated ageing by oven treatment. 11
Annex E (normative) Determination of compression and fatigue resistances of coil-spring and
flat-spring diaphragms . 13
Annex F (normative) Determination of twisting during compression of coil-spring and flat spring
diaphragms. 16
Annex G (normative) Determination of visible defects . 19
Annex H (normative) Test report. 23
Annex I (normative) Instructions for care and use of reusable rubber contraceptive diaphragms . 24
Bibliography . 26

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 8009 was prepared by Technical Committee ISO/TC 157, Mechanical contraceptives.
This first edition cancels and replaces ISO 8009-1:1997, ISO 8009-2:1985, ISO 8009-3:1985,
ISO 8009-4:1996, ISO 8009-5:1996, ISO 8009-6:1985, ISO 8009-7:1985, ISO 8009-8:1985, ISO 8009-9:1985
and ISO 8009-10:1985, which have been technically revised and incorporated into one document.
iv © ISO 2004 – All rights reserved

Introduction
Diaphragms are medical devices. Therefore, they should be produced under a good quality management
system. Reference should be made, for example to the ISO 9000 series, in conjunction with ISO 13485 or
ISO 13488 as appropriate.
The sampling plans and acceptance quality limits (AQLs) given in this International Standard are for referee
testing. The AQLs represent the maximum tolerable level of defects in the products. As diaphragms are
intended for re-use, manufacturers should strive for entirely defect-free product.
Manufacturers may devise and apply additional and alternative quality control measures for their use and after
production. These methods may differ among manufacturers.

INTERNATIONAL STANDARD ISO 8009:2004(E)

Mechanical contraceptives — Reusable natural and silicone
rubber contraceptive diaphragms — Requirements and tests
1 Scope
This International Standard specifies the minimum requirements and test methods to be used for reusable
diaphragms made from natural rubber and silicone rubber. These diaphragms are intended for contraceptive
use.
This International Standard is not applicable to other vaginal contraceptive barriers, such as those known as
cervical caps, vaginal sponges and vaginal sheaths.
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 188, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
ISO 463, Geometrical Product Specifications (GPS) — Dimensional measuring equipment — Design and
metrological characteristics of mechanical dial gauges
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 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type
hypersensitivity
3 Terms and definitions
For the purpose of this document, the terms and definition given in ISO 2859-1 and the following apply.
3.1
lot
batch
collection of diaphragms of the same design, colour, shape, size and formulation, manufactured at essentially
the same time, using the same process, common lots of raw materials, common equipment and personnel
NOTE The size of a lot is not specified in this International Standard, but it may be possible for a purchaser to do so
as part of a purchasing contract. Depending on the method of manufacture, multiple sizes can be produced in a defined
lot/batch. In such cases, traceability can be maintained by using both the lot number and the size.
4 Sampling
Sampling and establishment of the sampling plan shall be carried out as described in ISO 2859-1.
NOTE It is necessary to know the lot size in order to derive from ISO 2859-1 the number of samples to be tested.
The lot size varies among manufacturers, and is regarded as part of the process and quality controls used by the
manufacturer.
5 Classification
Diaphragms shall be classified into the following types:
a) Type 1: Coil-spring diaphragm, also known as a helically wound diaphragm.
b) Type 2: Flat-spring diaphragm, also known as a flat-leaf diaphragm, watch-spring diaphragm or Mensinga
diaphragm.
c) Type 3: Arcing-spring diaphragm, also known as an arcing-bend diaphragm or bow-bend diaphragm.
6 Materials
The diaphragm, excluding the spring, shall be made of a natural or silicone rubber compound.
When tested in accordance with ISO 10993-5, the diaphragm material and any lubricant, dressing material or
powder applied or recommended by the manufacturer shall not be cytotoxic. Spermicides applied at the time
of use are excepted from this requirement.
When tested in accordance with ISO 10993-10, the diaphragm and any lubricant, dressing material or powder
applied to it or recommended by the manufacturer shall not cause irritation or sensitization. Spermicides
applied at the time of use are excepted from this requirement, but manufacturers shall take steps to
recommend spermicides that minimize irritant effects.
The tests stipulated in ISO 10993-5 and ISO 10993-10 are type tests.
7 Design
7.1 General
The diaphragm shall consist of a dome and an integral peripheral rim. The dome of the diaphragm and the
portion forming the rim shall be one continuous film.
7.2 Rim
The rim of the diaphragm shall be reinforced with a spring, which shall be sufficiently rigid to hold the rim in a
flat, circular configuration.
7.3 Reinforcing spring
The reinforcing spring shall be completely encapsulated and centrally located within the rim.
7.4 Spr
...