ISO 4074 : 2015

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NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS

Available format(s): Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

Language(s): French, English

Published date: 01-01-2015

Publisher: International Organization for Standardization

Table of Contents - (Show below) - (Hide below)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality verification
5 Lot size
6 Biocompatibility
7 Microbial contamination
8 Product claims
9 Design
10 Bursting volume and pressure
11 Stability and shelf life
12 Freedom from holes
13 Visible defects
14 Package integrity of individual container
15 Packaging and labelling
16 Test report
Annex A (normative) - Sampling plans intended for assessing
        compliance of a continuing series of lots of sufficient
        number to allow the switching rules to be applied
Annex B (informative) - Sampling plans intended for
        assessing compliance of isolated lots
Annex C (normative) - Determination of total lubricant
        for condoms in individual containers
Annex D (normative) - Determination of length
Annex E (normative) - Determination of width
Annex F (normative) - Determination of thickness
Annex G (informative) - Determination of microbial
        contamination
Annex H (normative) - Determination of bursting
        volume and pressure
Annex I (normative) - Oven treatment for condoms
Annex J (informative) - Determination of force and
        elongation at break of test pieces of condoms
Annex K (normative) - Determination of shelf life by
        real-time stability studies
Annex L (informative) - Guidance on conducting and
        analysing accelerated ageing studies
Annex M (normative) - Testing for holes
Annex N (normative) - Testing for package integrity
Annex O (informative) - Calibration of air inflation
        equipment for determination of bursting volume
        and pressure
Annex P (informative) - Recommendations for testing
        condoms that fall outside of the size
        ranges specified in ISO 4074
Bibliography

Abstract - (Show below) - (Hide below)

This International Standard specifies requirements and test methods for male condoms made from natural rubber latex.

General Product Information - (Show below) - (Hide below)

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Development Note	Supersedes ISO 4074-1, ISO 4074-2, ISO 4074-3, ISO 4074-4, ISO 4074-5, ISO 4074-6, ISO 4074-7, ISO 4074-8, ISO 4074-9 and ISO 4074-10. (06/2002) Supersedes ISO/FDIS 4074. (10/2015)
Pages
ISBN
Committee	TC 157
Supersedes	ISO 4074-5 : 1996 ISO 4074-9 : 1996 ISO 4074-1 : 1996 ISO 4074-7 : 1996 ISO 4074-2 : 1994 ISO 4074-3 : 1994 ISO/FDIS 4074 : 60.00 (2015) ISO 4074-10 : 1990 ISO 4074 : 2014 ISO 4074-8 : 1984 ISO 4074-6 : 1996 ISO 4074-4 : 1980

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
DS EN ISO 4074 : 2015	Identical
NF EN ISO 4074 : 2015	Identical
NBN EN ISO 4074 : 2015	Identical
NEN EN ISO 4074 : 2015	Identical
NS EN ISO 4074 : 2002	Identical
I.S. EN ISO 4074:2015	Identical
PN EN ISO 4074 : 2016	Identical
SN EN ISO 4074 : 2016	Identical
UNI EN ISO 4074 : 2002	Identical
SS-EN ISO 4074:2015	Identical
ABNT NBR ISO 4074:2020	Identical
UNE-EN ISO 4074:2016	Identical
BS EN ISO 4074 : 2015	Identical
EN ISO 4074 : 2015	Identical
DIN EN ISO 4074 E : 2017	Identical
DIN EN ISO 4074:2016-05	Identical
DIN EN ISO 4074:2017-09	Identical
BS 3704(1989) : 1989	Similar to
SANS 4074 : 2ED 2017	Identical
SS-EN ISO 4074:2015	Identical
DIN EN ISO 4074:2017-09	Identical
BS EN ISO 4074 : 2015	Identical
ABNT NBR ISO 4074:2020	Identical
DIN EN ISO 4074:2016-05	Identical
PN EN ISO 4074 : 2016	Identical
UNE-EN ISO 4074:2016	Identical
NBR ISO 4074 : 2013	Identical
BIS IS/ISO 4074 : 2002(R2009)	Identical
SAC GB 7544 : 2004	Identical
I.S. EN ISO 4074:2015	Identical
DS EN ISO 4074 : 2015	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

07/30169357 DC : 0	BS ISO 25841 - FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
09/30195714 DC : 0	BS ISO 29941 - CONDOMS - DETERMINATION OF NITROSAMINES MIGRATING FROM NATURAL RUBBER LATEX CONDOMS INTO VARIOUS MEDIA
16/30346829 DC : 0	BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT CONDOMS
BS ISO 25841 : 2017	FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
14/30296392 DC : 0	BS ISO 29943-1 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
15/30302532 DC : 0	BS ISO 19671 - ADDITIONAL LUBRICANTS FOR CONDOMS - EFFECT ON CONDOM STRENGTH
BS ISO 29941 : 2010	CONDOMS - DETERMINATION OF NITROSAMINES MIGRATING FROM NATURAL RUBBER LATEX CONDOMS
DIN ISO 29941:2014-12	CONDOMS - DETERMINATION OF NITROSAMINES MIGRATING FROM NATURAL RUBBER LATEX CONDOMS (ISO 29941:2010)
BS ISO 29942 : 2011	PROPHYLACTIC DAMS - REQUIREMENTS AND TEST METHODS
BS ISO 16038 : 2017	MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT OF CONDOMS
BS ISO 23409 : 2011	MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS
09/30195717 DC : 0	BS ISO 29942 - PROPHYLACTIC DAMS - REQUIREMENTS AND TEST METHODS
15/30303073 DC : 0	BS ISO 25841 - FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
BS ISO 29943-1 : 2017	CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
08/30133979 DC : DRAFT MAY 2008	BS ISO 23409 - MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS
DIN ISO 29941 E : 2014	CONDOMS - DETERMINATION OF NITROSAMINES MIGRATING FROM NATURAL RUBBER LATEX CONDOMS (ISO 29941:2010)
ISO 29942:2011(R2016)	PROPHYLACTIC DAMS - REQUIREMENTS AND TEST METHODS
ISO 25841 : 2017	FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
ISO 23409 : 2011(R2015)	MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS
NBR ISO 16037 : 2009 AMD 1 2016	RUBBER CONDOM FOR CLINICAL TRIALS - MEASUREMENTS OF PHYSICAL PROPERTIES
ASTM D 7160 : 2016 : REDLINE	Standard Practice for Determination of Expiration Dating for Medical Gloves
ISO 29943-1 : 2017	CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
ISO 16037 : 2002(R2013)	RUBBER CONDOMS FOR CLINICAL TRIALS - MEASUREMENT OF PHYSICAL PROPERTIES
ASTM D 3492 : 2016 : REDLINE	Standard Specification for Rubber Contraceptives (Male Condoms)
ISO 29941 : 2010	CONDOMS - DETERMINATION OF NITROSAMINES MIGRATING FROM NATURAL RUBBER LATEX CONDOMS
ISO 16038 : 2017	MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT OF CONDOMS
(INACTIVE RECORD) DIN ISO 29941:2014-12	CONDOMS - DETERMINATION OF NITROSAMINES MIGRATING FROM NATURAL RUBBER LATEX CONDOMS (ISO 29941:2010)

Standards Referencing This Book - (Show below) - (Hide below)

ISO/IEC 17025 : 2005	GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES
EN ISO 10993-5 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY (ISO 10993-5:2009)
ISO 15223-2 : 2010	Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
ISO 11737-1 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
ISO 13485 : 2016(R2020)	MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
ISO 16038 : 2005	MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT OF CONDOMS
EN 1041 : 2008 + A1 2013	INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
EN ISO 15223-1 : 2016 COR 2017	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
ISO 3534-2 : 2006(R2014)	STATISTICS - VOCABULARY AND SYMBOLS - PART 2: APPLIED STATISTICS
ISO 10993-10 : 2010(R2016)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
ASTM D 3492 : 2016 : REDLINE	Standard Specification for Rubber Contraceptives (Male Condoms)
ISO 10993-1 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
ISO 5893 : 2002(R2012)	RUBBER AND PLASTICS TEST EQUIPMENT - TENSILE, FLEXURAL AND COMPRESSION TYPES (CONSTANT RATE OF TRAVERSE) - SPECIFICATION
ISO 9000 : 2015	QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY
ISO 14971 : 2007(R2010)	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
ISO 15223-1 : 2016	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
EN ISO 10993-1 : 2009 COR 2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
ISO/IEC GUIDE 98-3 : 2008	UNCERTAINTY OF MEASUREMENT - PART 3: GUIDE TO THE EXPRESSION OF UNCERTAINTY IN MEASUREMENT (GUM:1995)

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ISO 4074 : 2015

Table of Contents - (Show below) - (Hide below)

Abstract - (Show below) - (Hide below)

General Product Information - (Show below) - (Hide below)

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Standards Referenced By This Book - (Show below) - (Hide below)

Standards Referencing This Book - (Show below) - (Hide below)

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