ISO 19351:2019

Fallopian rings — Requirements and test methods

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.

Anneaux de fallope — Exigences et méthodes d’essai

General Information

• Status: Published
• Publication Date: 11-Jul-2019
• ICS: 11.200 - Birth control. Mechanical contraceptives
• Technical Committee: ISO/TC 157 - Non-systemic contraceptives and STI barrier prophylactics
• Drafting Committee: ISO/TC 157 - Non-systemic contraceptives and STI barrier prophylactics
• Current Stage: 6060 - International Standard published
• Start Date: 18-Mar-2019
• Completion Date: 12-Jul-2019

Standards Content (Sample)

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 19351:2019(E)
©
ISO 2019

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ISO 19351:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
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ISO 19351:2019(E)

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
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ISO 19351:2019(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.
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 voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/iso/foreword .html.
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
complete listing of these bodies can be found at www .iso .org/members .html.
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ISO 19351:2019(E)

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.
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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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ISO 19351:2019(E)

3.1
fallopian rings
elastic band made of medical grade silicone placed around a loop of fallopian tube bilaterally using
a laparoscopic surgical procedure or open surgery, cutting off the blood supply to occlude the tubal
lumen and prevent fertilization
3.2
lot
collection of fallopian rings (3.1) manufactured at essentially the same time, using raw materials of the
same specifications, the same process and common equipment, packed in the same type of individual
container
Note 1 to entry: The recommended maximum individual lot size for production is 10 000 pairs, but it is possible
for a purchaser to specify the lot size as part of the purchasing contract and quality management system of the
manufacturer.
3.3
lot number
number or combination of numerals, symbols or letters used by the manufacturer to identify a lot (3.2)
or individually packaged product, and from which it is possible to trace that lot through all stages of
manufacture up to packaging
3.4
lot test
test to assess the conformity of a lot (3.2)
Note 1 to entry: A lot test may be limited to include only those parameters which may change from lot to lot.
3.5
inspection level
relationship between lot size and sample size
Note 1 to entry: Inspection level designates the relative amount of inspection.
3.6
sampling plan
specific plan which indicates the number of units of products from each lot (3.2) which are to be
inspected (sample size or series of sample sizes) and the associated criteria for determining the
acceptability of the lot (acceptance and of manufacture to the use before date)
3.7
shelf life
period of time from the date of manufacture during which the fallopian rings (3.1) are required to
confirm to the requirements specified in this document
3.8
radio-opacity
quality or state of being radio-opaque
Note 1 to entry: It is the property of the material in obstructing the passage of radiation energy such as X-rays and
will produce a white image on the exposed X-ray film, which confirms that the implanted device is in position.
3.9
visible defects
defects which are visible to unaided eye during inspection, such as discolouration, any fibres or
protrusions on the fallopian ring
3.10
laparoscope
instrument inserted through an incision in the abdominal wall and used to visualize the surgical field,
where it has working channels with the applicator to insert the fallopian rings (3.1)
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ISO 19351:2019(E)

4 Requirements
4.1 Quality verification
Fallopian rings are mass produced articles manufactured in very large quantities. Inevitably, there will
be some variation between individual rings, and a small proportion of rings in each production run
might not meet the requirements of this document. Further, the majority of the test methods described
in this document are destructive. For these reasons, the only practicable method of assessing conformity
with this document is by testing a representative sample from a lot or series of lots. Basic sampling
plans are given in ISO 2859-1. Reference should be made to ISO/TR 8550 (all parts) for guidance on
the use of acceptance sampling system, scheme or plan for the inspection of discrete items in lots.
When on-going verification is required of the quality of fallopian rings, it is suggested that, instead of
concentrating solely on evaluation of the final product, attention is also directed at the manufacturer’s
quality system. It should be noted that ISO 13485 covers the provision of an integrated quality system
for the manufacture of medical devices. Sampling plans shall be selected to provide an acceptable level
of consumer protection. Suitable sampling plans are given in Annexes A and B.
a) Annex A describes sampling plans based on ISO 2859-1 and is most applicable to manufacturers
or purchasers assessing the conformity of a continuing series of lots. The full level of consumer
protection available depends upon the switch to tightened inspection if deterioration in quality
is detected. The switching rules, described in ISO 2859-1:1999, Clause 9, cannot offer their full
protection for the first two lots tested but become progressively more effective as the number of
lots in a series increases. Use the sampling plans in Annex A when five or more lots are being tested.
b) Annex B describes sampling plans, based on ISO 2859-1, that are recommended for the assessment
of isolated lots. The sampling plans in Annex B provide approximately the same level of consumer
protection as those given in Annex A when used with the switching rules. It is recommended that
these sampling plans are used for the assessment of fewer than five lots, for example in cases
of dispute, for referee purposes, for type testing, for qualification purposes or for short runs of
continuing lots.
It is necessary to know the lot size in order to derive the number of fallopian rings to be tested from
ISO 2859-1. The lot size will vary between manufacturers and is regarded as part of the process and
quality controls used by the manufacturer. If the lot size is not known or cannot be confirmed by the
manufacturer, then a lot size of 10,000 fallopian rings shall be assumed for determining the sample
sizes for testing.
4.2 Physical requirements
4.2.1 Dimensions
Fallopian rings are tested for the inner diameter and outer diameter in accordance with Annex C and
shall conform to the requirements given in Figure 1.
Cut rings shall be free from fibrous protrusions at the outer and inner surface. Angle of cut shall be at
90° (≤5° angulations is allowed).
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ISO 19351:2019(E)

Dimensions in millimetres
Figure 1 — Fallopian ring
4.2.2 Tensile properties
Fallopian rings tested in accordance with Annex D for the tensile properties shall conform to the
requirements stated below.
a) The force at break shall be ≥20,50 N.
b) Elongation at force at break shall be ≥560 %.
4.2.3 Loading force on ring applicator
Fallopian rings tested in accordance with Annex E for the force of loading on ring applicator shall
conform to the requirement stated below.
The force required to load fallopian rings on the ring applicator shall be ≤35 N.
4.2.4 Elastic memory
Fallopian rings tested in accordance with Annex F for the elastic memory shall conform to the
requirement stated below.
The recovery of the inner diameter shall be such that the increase in the inner diameter ≤25 % of the
original diameter.
4.2.5 Repeat loading strength
Fallopian rings tested in accordance with Annex G for the repeat loading strength shall neither break
nor develop any cracks when viewed using ×20 magnification.
4.2.6 Visible defects
Fallopian rings tested for the visible defects shall not have defects such as discolouration, any fibres or
protrusions on the ring.
4.3 Packaging
4.3.1 Packing mode
One pair of fallopian rings shall be packaged in peel open pouch/blister pack with seal width ≥2 mm.
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ISO 19351:2019(E)

4.3.2 Primary pouch
Each pouch/blister pack shall ensure:
a) adequate protection of the contents during normal handling, transit and storage for a period of
4 years;
b) maintenance of sterility of the contents under dry, clean and adequately ventilated storage
conditions at a temperature(s) ranging from 0 °C to 50 °C; and
c) minimal risk for contamination of the contents during removal from the pouch/blister pack.
4.3.3 Instruction for use
Every dispenser box shall be provided with at least one instruction for use describing the method to be
adopted for:
a) loading of rings on the ring applicator; and
b) storage and handling requirements in clean and dry place.
4.3.4 Package seal strength
Fallopian rings packs shall be tested for package seal integrity and seal strength in accordance with
Annex J and peel force shall be 4,4 N to 19,0 N.
4.3.5 Package seal integrity
Fallopian rings packs shall be tested for package seal integrity and seal strength in accordance with
Annex J and there shall be no evidence of leakage of the package.
4.3.6 Sterility
Fallopian rings supplied as sterile shall meet the requirements of sterility test as specified in the latest
version of national/international pharmacopoeia.
The manufacturer shall establish procedures and systems to validate the type of sterilization used for
the fallopian rings as sterility testing alone cannot be deemed as the criteria for confirming the sterility
of the product. Validation of ethylene oxide sterilization process shall be done according to ISO 11135
and gamma sterilization shall be done according to ISO 11137-1 and ISO 11137-2.
4.4 Biological requirements
The biological safety of fallopian rings shall be evaluated in accordance with the principles given in
ISO 10993-1, according to which fallopian rings are classified as a permanent contact implant device,
and the following tests shall be complied with:
a) cytotoxicity as per ISO 10993-5;
b) sensitization as per ISO 10993-10;
c) irritation or intracutaneous reactivity as per ISO 10993-10;
d) subchronic (Subacute) toxicity as per ISO 10993-11;
e) genotoxicity as per ISO 10993-3;
f) acute systemic toxicity as per ISO 10993-11;
g) implantation as per ISO 10993-6.
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ISO 19351:2019(E)

These tests shall be repeated only in the case of a significant change such as change in formulation or
grade of silicone tubing material, change in sterilization method, change in manufacturing process, etc.
The results of the test shall be reviewed and interpreted by a qualified toxicologist.
4.5 Radio-opacity
Fallopian rings shall be radiopaque. This test shall be a type test used for the initial evaluation of the
silicone elastomeric tubing material. ASTM F640 shall be referred for determining radio-opacity of the
elastomeric material.
4.6 Clinical evaluation
4.6.1 General
Fallopian rings made of silicone-based elastomer have been used to effect female sterilization for nearly
[8]
50 years. They have been studied extensively, and clinical reports from the published literature show
a long history of safety and effectiveness. Rings manufactured in accordance with the requirements of
this document are expected to have comparable clinical performance. This means the manufacturers’
fallopian rings are similar to the fallopian rings used in the cited published clinical studies and comply
with this document with respect to the following characteristics:
— peak load;
— elongation at peak load;
— strain capacity;
— loading force on ring applicator;
— elastic memory;
— repeat loading strength.
To establish conformance with this document for a new design of fallopian rings, the manufacturer
shall demonstrate, using a one-sided test, that the upper limit of the 95 % confidence interval for a
one-year pregnancy rate is ≤2,0 %. To establish this, the manufacturer shall sponsor a clinical study of
its new design and demonstrate clinical safety and effectiveness. Completion of the one-year phase of
the study is sufficient to begin marketing. However, the women in the study should be followed for an
additional four years to record any additional pregnancies and serious adverse events.
4.6.2 New clinical study of manufacturer’s fallopian rings
A manufacturer may make significant changes to the fallopian ring with respect to design, materials or
manufacturing procedures. In this case, the manufacturer shall sponsor a clinical study of its fallopian
ring and demonstrate clinical safety and effectiveness. To this end, the sponsor shall conduct a single-
arm clinical study, enrolling sexually-active women of reproductive age, following these women for a
total of five years. Biostatistical analysis of the study shall show, using a one-sided test, that the upper
limit on the 95 % confidence interval for the one-year failure rate (pregnancy) is less than 2,0 %.
Completion of the one-year phase of the study is sufficient to begin marketing. However, the women in
the study should be followed for an additional four years (a total of five years) to record any additional
pregnancies and serious adverse events. Any unusual findings shall be included in updated labelling.
5 Storage condition
The fallopian rings shall be stored at a temperature ranging from 0 °C to 50 °C.
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ISO 19351:2019(E)

6 Labelling
6.1 If symbols are used on packaging information and marketing materials, the symbols shall meet the
requirements as given in ISO 15223-1 and ISO 15223-2.
6.2 Printing and illustrations shall be clear, legible and indelible. If labels are used, they shall be free
from gross particulate matter and fibres.
6.3 Each individual container shall be marked with the following:
a) full name and address of manufacturer;
b) batch number;
c) method, month and year of sterilization (for year use four digits);
d) storage directives;
e) use/implant before (specify month and year, or year and month as per the national regulation; use
four digits for year).
6.4 In addition to those stated in 6.3, each individual package shall carry the following text:
a) warning-sterile unless package is opened or damaged;
b) fallopian rings shall not be kept loaded on the applicator for more than 15 minutes;
c) a reference to this document (i.e. ISO 19351:2019) and reference to the instructions for use;
d) the pouch/blister pack, once opened, shall not be resealed;
e) any other requirement(s) mandated by the regulatory authorities in the country of use.
7 Shelf life
7.1 General
The fallopian rings shall meet performance specification as per the requirements given in Clause 4 for
the complete duration of the declared shelf life.
In case of a significant change in formulation, grade or source of the silicone tubing raw material, change
in construction of the primary packing material, sterilization method, or manufacturing process, the
shelf life of the fallopian rings shall be established by the following processes.
7.2 Procedure for determining shelf life by real-time stability studies
After testing in accordance with Annex H, the fallopian rings shall meet the requirements given in
Clause 4. If the real time data indicate a shorter shelf life than that claimed on the basis of accelerated
stability studies, the manufacturer shall notify the relevant regulatory authorities and direct purchasers
on the shelf life of the product. The manufacturer shall change the shelf life claim for the product based
upon the real time study. In no case shall the shelf life exceed 4 years. Real-time stability studies shall
be performed for the full period of the shelf-life claim.
7.3 Procedure for determining shelf life by
...