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

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Status
Published
Publication Date
11-Jul-2019
Current Stage
6060 - International Standard published
Start Date
09-Jun-2019
Completion Date
12-Jul-2019
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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
ii © ISO 2019 – All rights reserved
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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

© ISO 2019 – All rights reserved iii
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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.
iv © ISO 2019 – All rights reserved
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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.
© ISO 2019 – All rights reserved v
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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/
© ISO 2019 – All rights reserved 1
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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)

2 © ISO 2019 – All rights reserved
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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.
6 © ISO 2019 – All rights reserved
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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
...

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