ISO 8009:2004
(Main)Mechanical contraceptives — Reusable natural and silicone rubber contraceptive diaphragms — Requirements and tests
Mechanical contraceptives — Reusable natural and silicone rubber contraceptive diaphragms — Requirements and tests
ISO 8009:2004 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. ISO 8009:2004 is not applicable to other vaginal contraceptive barriers, such as those known as cervical caps, vaginal sponges and vaginal sheaths.
Contraceptifs mécaniques — Diaphragmes contraceptifs réutilisables en caoutchouc — Performances et essais
General Information
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Standards Content (Sample)
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 8009:2004(E)
©
ISO 2004
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ISO 8009:2004(E)
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ii © ISO 2004 – All rights reserved
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ISO 8009:2004(E)
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
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ISO 8009:2004(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 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.
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ISO 8009:2004(E)
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.
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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.
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ISO 8009:2004(E)
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 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.
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ISO 8009:2004(E)
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
Property Natural rubber Natural rubber Silicone rubber Silicone rubber
untreated oven-treated untreated oven-treated
Tensile strength, MPa 15 11 7 7
Elongation at break, % 650 500 350 350
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ISO 8009:2004(E)
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 9000 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; and
f) illegible labelling.
For minor defects, when tested in accordance with Annex G, the compliance level shall be an AQL of 1,0 %.
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ISO 8009:2004(E)
12 Test report
Test reports shall contain at least the information as described in Annex H.
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.
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.
The individual container shall be reusable so that it can be used to protect the diaphragm for the term of its
useful life.
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; and
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; and
e) the material of which the diaphragm is made.
13.2.3 Instructions
Each individual container shall contain instructions for the use and care of the diaphragm in accordance with
Annex I.
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ISO 8009:2004(E)
13.3 Storage
Rubber tends to deteriorate with age. Diaphragms are packed in a way which normally protects them during
storage. Nevertheless, they should not be kept in stock longer than necessary, especially in warm climates.
They should be stored in a cool, dry place and should be kept in containers such that the contents will not be
subject to mechanical damage or light. As soon as any diaphragm shows deterioration (e.g. tackiness,
brittleness, crazing) of the rubber, it should be destroyed.
The diaphragm should not be allowed to come into contact with oil-based antiseptic phenols and their
derivatives, petroleum-based grease, petroleum spirit, kerosene and other related organic products.
Normally it is recommended to destroy test diaphragms after tests are completed. Sometimes diaphragms
need to be kept to demonstrate particular problems, thus it is important that these diaphragms be marked or
stored in such a way that unintentional use is prevented.
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ISO 8009:2004(E)
Annex A
...
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