ISO 8009:2014

INTERNATIONAL ISO
STANDARD 8009
Second edition
2014-11-15
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 2014
© ISO 2014
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Published in Switzerland
ii © ISO 2014 – 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 Mechanical properties of rim and spring — Type 1 and Type 2 diaphragms .4
10.1 Compression resistance . 4
10.2 Twisting during compression . 4
11 Freedom from visible defects . 4
12 Test report . 4
13 Packaging, labelling, and storage . 5
13.1 Packaging . 5
13.2 Labelling . 5
13.3 Storage . 5
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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 157, Non-systemic contraceptives and STI barrier
prophylactics.
This second edition cancels and replaces the first edition, ISO 8009:2004, of which it constitutes a minor
revision. It also incorporates the amendment ISO 8009:2004/Amd1:2012.
iv © ISO 2014 – 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.
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 can devise and apply additional and alternative quality control measures for their use
and after production. These methods can differ among manufacturers.
INTERNATIONAL STANDARD ISO 8009:2014(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 documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
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 skin sensitization
3 Terms and definitions
For the purpose of this document, the terms and definitions 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 1 to entry: The size of a lot is not specified in this International Standard, but it can be specified by a purchaser
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.
For any new product or following a significant change to the formulation or manufacturing process,
biocompatibility assessments shall be conducted in accordance with ISO 10993-1. Testing for cytotoxicity,
in accordance with ISO 10993-5, and for irritation and sensitization, in accordance with ISO 10993-10,
shall be conducted. Spermicides applied at the time of use are exempt from this requirement. Where
practicable, manufacturers should take steps to recommend spermicides that minimize irritant
effects. Accredited laboratories shall be used for all biocompatibility testing. Regulatory bodies might
also specify local requirements and require results to be interpreted by a qualified toxicologist. Any
toxicologist’s assessment report shall state that the product is safe under normal conditions of use.
NOTE Many latex products that have been established as safe, including diaphragms and medical gloves,
can exhibit a positive cytotoxic response when tested according to ISO 10993-5. While any cytotoxic effect can
be of concern, it is primarily an indication of potential for in vivo toxicity, and a diaphragm cannot necessarily be
determined to be unsuitable for use based solely on cytotoxicity data.
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 Spring ends
The ends of the spring shall be joined in such a manner that the joint does not project through the
surface of the rim.
2 © ISO 2014 – All rights reserved

7.5 Dome and rim
The dome and rim shall have a uniform, smooth, and non-tacky finish.
8 Dimensions
8.1 Diameter
The nominal diameters of preferred sizes shall be 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, 80 mm, 85 mm,
90 mm, 95 mm, and 100 mm.
When tested in accordance with Annex A, the two diameter measurements shall not differ by more than
4 % of the nominal size. The mean of these two measurements, called diaphragm diameter, shall equal
the nominal size within a tolerance of ±2 mm.
Examine 13 diaphragms of each size. No diaphragm diameter shall fall outside the limits.
8.2 Dome thickness
When tested in accordance with Annex B, the thickness of the diaphragm dome at the thinnest point
measured shall not be less than 0,20 mm.
9 Tensile properties of the dome
9.1 Tensile strength
When tested in accordance with Annex C, the median tensile strength of 13 diaphragms of each size
shall not be less than the values given in Table 1.
When tested in accordance with Annex D, the median tensile strength of 13 oven-treated diaphragms of
each size shall not be less than the values given in Table 1.
9.2 Elongation at break
When tested in accordance with Annex C, the median elongation at break of 13 untreated diaphragms of
each size shall not be less than the values given in Table 1.
When tested in accordance with Annex D, the median elongation at break of 13 oven-treated diaphragms
of each size shall not be less than the values given in Table 1.
Table 1 — Minimum median tensile properties
Natural rubber Natural rubber Silicone rubber Silicone rubber
Property
untreated oven-treated untreated oven-treated
Tensile strength,
15 11 7 7
MPa
Elongation at break,
650 500 350 350
%
10 Mechanical properties of rim and spring — Type 1 and Type 2 diaphragms
10.1 Compression resistance
When 13 diaphragms are tested in accordance with Annex E, during the first and 1 000th compressions
the distance between the load points, i.e. resulting from compression, of each diaphragm shall not be
lower than 55 % and not greater than 85 % of the original diameter.
After the 1 000th compression, the diameter along the axis of compression shall be at least 90 % of the
value measured before the test.
After the 1 000th compression, the rubber film shall show no signs of deterioration when examined by
normal or corrected vision.
The degree of twist after 1 000 compressions, measured in accordance with Annex F, shall be not more
than 20°.
Manufacturers of diaphragms who are certified to the ISO 9001 quality management system or
equivalent, and whose suppliers are similarly certified, may use the repeated compression testing part
of this method as a type test. In that case, lot-by-lot testing shall consist of a single compression, and
measurement of the compression resistance.
10.2 Twisting during compression
When tested in accordance with Annex F, the diaphragm shall not show an angle of twist greater than
20°.
Each lot shall be sampled in accordance with ISO 2859-1:1999, General inspection level I, but at least
according to code letter K.
When tested in accordance with Annex F, the compliance level shall be an AQL of 1,0 %.
11 Freedom from visible defects
When inspected in accordance with Annex G, the diaphragm shall not show any visible defects.
Each lot shall be sampled in accordance with ISO 2859-1:1999, General inspection level I, but at least
according to code letter K.
The compliance level shall be an AQL of 0,4 % for the following major defects:
a) hole in the dome;
b) exposed spring;
c) broken spring;
d) distorted shape;
e) illegible marking on the diaphragm;
f) illegible labelling.
For minor defects, when tested in accordance with Annex G, the compliance level shall be an AQL of
1,0 %.
12 Test report
Test reports shall contain at least the information as described in Annex H.
4 © ISO 2014 – All rights reserved

13 Packaging, labelling, and storage
13.1 Packaging
13.1.1 Individual container
Each diaphragm shall be individually packaged in a container designed to protect it from contamination,
exposure to light ,and mechanical damage during normal handling, transport, and storage.
The individual container shall be reusable so that it can be used to protect the diaphragm for the term
of its useful life.
13.1.2 Outer container(s)
A convenient number of individual containers shall be packed in one or more outer containers which
shall be sufficiently robust to protect the contents during transport and storage.
13.2 Labelling
13.2.1 Diaphragm identification
Each diaphragm shall be legibly marked with the following information:
a) the manufacturer’s name or recognized trademark;
b) the nominal size, in millimetres.
13.2.2 Individual container identification
The container, as received by the user, shall be legibly marked with the following information:
a) the manufacturer’s and/or distributor’s name or recognized trademark;
b) the manufacturer’s lot number;
c) the nominal size, in millimetres;
d) the manufacturer’s recommended last date for supply to the consumer (month and year), i.e. the
date after which the diaphragm should not be distributed to consumers. This date shall be no more
than two years from the date of manufacture, unless justified by real-time or accelerated test data;
e) the material of which the diaphragm is made.
13.2.3 Instructions
Each individual contain
...