iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ISO

ISO 4074-6:1984

(Main)

Rubber condoms — Part 6: Determination of bursting volume and pressure

Rubber condoms — Part 6: Determination of bursting volume and pressure

Préservatifs masculins en caoutchouc — Partie 6: Détermination du volume et de la pression d'éclatement

General Information

Status
Withdrawn
Publication Date
30-Apr-1984
Withdrawal Date
30-Apr-1984
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
9599 - Withdrawal of International Standard
Completion Date
15-Aug-1996
Ref Project

Relations

Revised
ISO 4074-6:1996 - Rubber condoms — Part 6: Determination of bursting volume and pressure
Effective Date
15-Apr-2008
Revises
ISO 4074-6:1981 - Rubber condoms — Part 6: Determination of bursting volume and pressure
Effective Date
15-Apr-2008

Buy Standard

ISO 4074-6:1984 - Rubber condomsISO 4074-6:1984 - Rubber condoms
PreviousNext
Standard
ISO 4074-6:1984 - Rubber condoms
English language
2 pages
sale 15% off
Preview
sale 15% off
Preview
ISO 4074-6:1984 - Préservatifs masculins en caoutchoucISO 4074-6:1984 - Préservatifs masculins en caoutchouc
PreviousNext
Standard
ISO 4074-6:1984 - Préservatifs masculins en caoutchouc
French language
2 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)

International Standard @ 4074/6
INTERNATIONAL ORGANIZATION FOR STANOARDIZATION*MEX~YHAPO~HAR OPrAHHJAUHR fl0 CTAHAAPTH3AUMM*ORGANlSATlON INTERNATIONALE DE NORMALISATION
)il) Rubber condoms -
Part 6 : Determination of bursting volume and pressure
Préservatifs masculins en caoutchouc - Partie 6 : Détermination du volume et de la pression d‘éclatement
Second edition - 1984-05-15
-
Lu
-
UDC 615.477.86 Ref. No. IS0 4074/6-1984 (E)
8
5
Descriptors : birth control, contraceptives, condoms, tests, burst tests, determination, pressure, volume.
$
3
O
E Price based on 2 pages
I?

---------------------- Page: 1 ----------------------
Foreword
IS0 (the International Organization for Standardization) is a worldwide federation of
national standards bodies (IS0 member bodies). The work of developing International
Standards is carried out through IS0 technical committees. Every member body
interested in a subject for which a technical committee has been authorized 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.
Draft International Standards adopted by the technical committees are circulated to
the member bodies for approval before their acceptance as International Standards by
the IS0 Council.
International Standard IS0 4074/6 was developed by Technical Committee
ISO/TC 157, Mechanical contraceptives, and was circulated to the member bodies in
March 1983.
It has been approved by the member bodies of the following countries :
Australia Germany, F.R. Poland
China India South Africa, Rep. of
Czechoslovakia Italy Sweden
Denmark Korea, Rep. of Thailand
Egypt, Arab Rep. of Mexico United Kingdom
France Netherlands USSR
The member body of the following country expressed disapproval of the document on
technical grounds :
USA
This second editi
...

Norme internationale @ 407416
INTERNATIONAL ORGANIZATION FOR STANDAADIZATIONOMEMAYHAPOllHAR OPrAHM3AUHR no CTAHAAPTM3AUMM*ORGANlSATlON INTERNATIONALE DE NORMALISATION
Préservatifs masculins en caoutchouc -
Partie 6 : Détermination du volume
et de la pression d'éclatement
Rubber condoms - Part 6 : Determination of bursting volume and pressure
Deuxième édition - 1984-05-15
CDU 615.477.86 Réf. no : IS0 4074/6-1984 (FI
Descripteurs : contrôle des naissances, contraceptif, préservatif masculin, essai, essai d'éclatement, détermination, pression, volume.
Prix basé sur 2 pages

---------------------- Page: 1 ----------------------
Avant- propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale
d'organismes nationaux de normalisation (comités membres de I'ISO). L'élaboration
des Normes internationales est confiée aux comités techniques de I'ISO. Chaque
comité membre intéressé par une étude a le droit de faire partie du comité technique
correspondant. Les organisations internationales, gouvernementales et non gouverne-
mentales, en liaison avec I'ISO, participent également aux travaux.
Les projets de Normes internationales adoptés par les comités techniques sont soumis
aux comités membres pour approbation, avant leur acceptation comme Normes inter-
nationales par le Conseil de I'ISO.
La Norme internationale IS0 4074/6 a été élaborée par le comité technique ISO/TC 57,
Contraceptifs mécaniques, et a été soumise aux comités membres en mars 1983.
Les comités membres des pays suivants l'ont approuvée :
Afrique du Sud, Rép. d' Egypte, Rép. arabe d' Pologne
Allemagne, R. F. France Royaume-Uni
Australie Inde Suède
Chine Italie Tchécoslovaquie
Thaïlande
Corée, Rép. de Mexique
Danemark Pays-Bas URSS
Le comité membre du pays suivant l'a désapprouvée pour des raisons techniques :
USA
Cette deuxième édition annule et remplace la première édition (IS0 4074/6-1981).
O Organisation internationale de normalisation, 1984 O
Impr
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

ISO
ISO 7439:2023(Main)
Copper-bearing contraceptive intrauterine devices — Requirements and tests

This document specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens or other medicinal products. NOTE Some aspects of this document can be applicable to medicated intrauterine devices and IUDs not containing copper.

  • Standard
    16 pages
    English language
    sale 15% off
  • Standard
    17 pages
    French language
    sale 15% off
  • Draft
    16 pages
    English language
    sale 15% off
  • Draft
    16 pages
    English language
    sale 15% off
  • Draft
    18 pages
    French language
    sale 15% off
ISO
ISO/TR 24484:2023(Main)
Female condoms — Use of ISO 25841 and the quality management of female condoms

This document gives the essential principles in the application of ISO 25841. It outlines the details of elements applicable in quality management of female condoms as required by related normative standards, as referred in ISO 25841 and other relevant concepts. This document supplements the use of ISO 25841 and addresses quality management aspects to be considered during the development, manufacture, quality verification and procurement of female condoms. It encompasses the principles of quality management systems in design, manufacture, and delivery of female condoms with emphasis on their performance, safety and reliability. This document is applicable to female condoms made of natural rubber or synthetic rubber or synthetic polymers and the retention devices which form the integral components of female condoms. NOTE Female condoms made from either natural rubber latex or synthetic rubber or other synthetic polymeric materials are addressed in ISO 25841.

  • Technical report
    13 pages
    English language
    sale 15% off
ISO
ISO 25841:2017/Amd 1:2020(Amendment)
Female condoms — Requirements and test methods — Amendment 1
  • Standard
    1 page
    English language
    sale 15% off
ISO
ISO 19351:2019(Main)
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.

  • Standard
    27 pages
    English language
    sale 15% off
ISO
ISO 19671:2018(Main)
Additional lubricants for male natural rubber latex condoms — Effect on condom strength

This document specifies a method of assessing the effect or compatibility of an additional or personal lubricant with lubricated male natural rubber latex condoms. It also applies to topical medicines and any other substances that come into contact with such condoms. It describes the measurement of changes in physical properties of the condoms after exposure to the test substance (i.e. lubricant, topical medicine, etc.) and specifies the pass/fail criteria for such changes. This document is not applicable to the assessment of the compatibility of lubricants applied to a condom at the time of manufacture. It is not directly applicable to the assessment of the compatibility of a particular condom with lubricants or other substances. It is not directly applicable to tests using female condoms, although similar principles can apply. The test methods are applicable to condoms made from natural rubber latex and from synthetic materials, but a pass/fail criterion is only stipulated for natural rubber latex.

  • Standard
    15 pages
    English language
    sale 15% off
ISO
ISO/TR 19969:2018(Main)
Guidance on sample handling for determination of bursting volume and pressure, and testing for freedom from holes for male condom

This document gives guidance on the procedures for sample preparation for determining bursting volume and pressure and testing male condoms for freedom from holes.

  • Technical report
    9 pages
    English language
    sale 15% off
ISO
ISO 11249:2018(Main)
Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies

ISO 11249:2018 provides guidance on the design and conduct of clinical studies to determine the performance characteristics of new intrauterine devices. It also provides advice on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers, researchers and regulatory bodies. ISO 11249:2018 is intended to ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, and to assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. Certain clinical trial concerns are not addressed in this document, including subject compensation, confidentiality of subjects and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in great detail in ISO 14155.

  • Standard
    23 pages
    English language
    sale 15% off
ISO
ISO 16038:2017(Main)
Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms

ISO 16038:2017 provides guidance on using ISO 4074 and ISO 23409 and addresses quality issues to be considered during the development, manufacture, quality verification and procurement of condoms. It encompasses the aspects of quality management systems in the design, manufacture and delivery of condoms with an emphasis on performance, safety and reliability. Male condoms are either made from essentially natural rubber latex, in which case the requirements of ISO 4074 are applicable, or from synthetic materials and/or blends of synthetic materials and natural rubber latex, in which case the requirements of ISO 23409 are applicable. This document outlines the aspects applicable to both types of condoms with specific clarifications where appropriate.

  • Standard
    12 pages
    English language
    sale 15% off
ISO
ISO 25841:2017(Main)
Female condoms — Requirements and test methods

ISO 25841:2017 specifies the minimum requirements and test methods for female condoms that are supplied to consumers for contraceptive purposes and for assisting in the prevention of sexually transmitted infections (STIs).

  • Standard
    54 pages
    English language
    sale 15% off
ISO
ISO 29943-2:2017(Main)
Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports

ISO 29943-2:2017 is intended to help in the design, execution, analysis, and interpretation of clinical function studies conducted in accordance with the requirements of ISO 25841 for female condoms. These clinical studies compare the performance of a new female condom to an established female condom during vaginal intercourse (not anal intercourse). In particular, these studies are designed to assess acute failure events during use. ISO 29943-2:2017 also provides direction on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers and regulatory bodies. Certain clinical trial elements are not addressed in this document, including compensation, confidentiality of individuals and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in greater detail in ISO 14155.

  • Standard
    40 pages
    English language
    sale 15% off