ISO 19351:2019

INTERNATIONAL ISO
STANDARD 19351
First edition
2019-07
Fallopian rings — Requirements and
test methods
Anneaux de fallope — Exigences et méthodes d’essai
Reference number
©
ISO 2019
© ISO 2019
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Published in Switzerland
ii © ISO 2019 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 Quality verification . 3
4.2 Physical requirements . 3
4.2.1 Dimensions . 3
4.2.2 Tensile properties . 4
4.2.3 Loading force on ring applicator . 4
4.2.4 Elastic memory . 4
4.2.5 Repeat loading strength . . . 4
4.2.6 Visible defects . . 4
4.3 Packaging . 4
4.3.1 Packing mode . 4
4.3.2 Primary pouch . 5
4.3.3 Instruction for use . 5
4.3.4 Package seal strength . 5
4.3.5 Package seal integrity . 5
4.3.6 Sterility . 5
4.4 Biological requirements . 5
4.5 Radio-opacity . 6
4.6 Clinical evaluation . 6
4.6.1 General. 6
4.6.2 New clinical study of manufacturer’s fallopian rings . 6
5 Storage condition . 6
6 Labelling . 7
7 Shelf life . 7
7.1 General . 7
7.2 Procedure for determining shelf life by real-time stability studies . 7
7.3 Procedure for determining shelf life by accelerated stability studies . 7
Annex A (normative) Sampling plan and acceptance criteria for a continuing series of lot .8
Annex B (informative) Sampling plans intended for assessing compliance of isolated lots .9
Annex C (normative) Determination of dimensions .10
Annex D (normative) Determination of tensile properties .11
Annex E (normative) Determination of loading force on ring applicator .13
Annex F (normative) Determination of elastic memory .18
Annex G (normative) Determination of repeat loading strength .19
Annex H (normative) Determination of shelf life by real time stability study .21
Annex I (normative) Determination of shelf life by accelerated stability study .23
Annex J (normative) Package seal integrity and seal strength .24
Annex K (normative) Reporting of test results .26
Bibliography .27
Foreword
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electrotechnical standardization.
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This document was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI
barrier prophylactics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
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iv © ISO 2019 – All rights reserved

Introduction
Fallopian rings are devices which provide permanent contraception. These devices are elastic bands
made from medical grade silicone. They are implanted bilaterally using a laparoscopic surgical
procedure. After the rings are applied to each fallopian tube, they cut off the blood supply and occlude
the tubal lumen. This stops the ova from travelling to the uterus, thereby preventing fertilisation.
Fallopian rings are provided sterile and packaged as a set of two.
This document has been necessitated as a result of the product marketing experience gained by
manufacturers and procurement agencies.
INTERNATIONAL STANDARD ISO 19351:2019(E)
Fallopian rings — Requirements and test methods
1 Scope
This document specifies the minimum requirements and test methods for fallopian rings used for tubal
occlusion in women for permanent contraception. This document does not address the applicator or
other accessories used to place the fallopian rings.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and
reproductive toxicity
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling, and information
to be supplied — Part 2: Symbol development, selection and validation
ASTM F640, Standard test methods for determining radiopacity for medical use
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
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