ISO 8009:2014
Mechanical contraceptives — Reusable natural and silicone rubber contraceptive diaphragms — Requirements and tests
ISO 8009:2014 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.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$240.87 NZD
|
|
| HardCopy |
$277.39 NZD
|
|
| Networkable PDF |
Price varies
|
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Sampling
5 Classification
6 Materials
7 Design
7.1 General
7.2 Rim
7.3 Reinforcing spring
7.4 Spring ends
7.5 Dome and rim
8 Dimensions
8.1 Diameter
8.2 Dome thickness
9 Tensile properties of the dome
9.1 Tensile strength
9.2 Elongation at break
10 Mechanical properties of rim and spring — Type 1 and Type 2 diaphragms
10.1 Compression resistance
10.2 Twisting during compression
11 Freedom from visible defects
12 Test report
13 Packaging, labelling, and storage
13.1 Packaging
13.2 Labelling
13.3 Storage
Annex A (normative) Determination of size
Annex B (normative) Determination of dome thickness
Annex C (normative) Determination of tensile properties
Annex D (normative) Determination of deterioration after accelerated ageing by oven treatment
Annex E (normative) Determination of compression and fatigue resistances of coil-spring and flat-spring diaphragms
Annex F (normative) Determination of twisting during compression of coil-spring and flat spring diaphragms
Annex G (normative) Determination of visible defects
Annex H (normative) Test report
Annex I (normative) Instructions for care and use of reusable rubber contraceptive diaphragms
Bibliography
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
Related Information
Similar Standards
-
BS EN ISO 4074:2015
Natural rubber latex male condoms. Requirements and test methods
-
BS EN ISO 4074:2015 - TC
Tracked Changes. Natural rubber latex male condoms. Requirements and test methods
-
BS EN ISO 7439:2023
Copper-bearing contraceptive intrauterine devices. Requirements and tests
-
BS ISO 11249:2018
Copper-bearing intrauterine contraceptive devices. Guidance on the design, execution, analysis and interpretation of clinical studies
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Sampling
5 Classification
6 Materials
7 Design
7.1 General
7.2 Rim
7.3 Reinforcing spring
7.4 Spring ends
7.5 Dome and rim
8 Dimensions
8.1 Diameter
8.2 Dome thickness
9 Tensile properties of the dome
9.1 Tensile strength
9.2 Elongation at break
10 Mechanical properties of rim and spring — Type 1 and Type 2 diaphragms
10.1 Compression resistance
10.2 Twisting during compression
11 Freedom from visible defects
12 Test report
13 Packaging, labelling, and storage
13.1 Packaging
13.2 Labelling
13.3 Storage
Annex A (normative) Determination of size
Annex B (normative) Determination of dome thickness
Annex C (normative) Determination of tensile properties
Annex D (normative) Determination of deterioration after accelerated ageing by oven treatment
Annex E (normative) Determination of compression and fatigue resistances of coil-spring and flat-spring diaphragms
Annex F (normative) Determination of twisting during compression of coil-spring and flat spring diaphragms
Annex G (normative) Determination of visible defects
Annex H (normative) Test report
Annex I (normative) Instructions for care and use of reusable rubber contraceptive diaphragms
Bibliography