ISO 16037 : 2002(R2013)

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RUBBER CONDOMS FOR CLINICAL TRIALS - MEASUREMENT OF PHYSICAL PROPERTIES

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Published date: 01-01-2002

Publisher: International Organization for Standardization

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Length
5 Width
6 Thickness
7 Bead
8 Air inflation properties
9 Tensile properties
10 Lubricant
11 Freedom from holes and visible defects
12 Information from manufacturer
13 Follow-up studies
Bibliography

Abstract - (Show below) - (Hide below)

This International Standard is intended as a guideline for clinical researchers working with condoms.

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Published
Document Type	Revision
Status	Current
Publisher	International Organization for Standardization
Development Note	Supersedes ISO/FDIS 16037 (06/2002)
Pages
ISBN
Committee	TC 157

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

Equivalent Standard(s)	Relationship
BIS IS/ISO 16037 : 2002 AMD 1 2015	Identical
NF ISO 16037 : 2002	Identical
SANS 16037 : 1ED 2003(R2008)	Identical
DS ISO 16037 : 2002	Identical
NEN ISO 16037 : 2002 AMD 1 2011	Identical
GOST ISO 16037 : 2014	Identical
NBR ISO 16037 : 2009 AMD 1 2016	Identical
NBR ISO 16037 : 2009 AMD 1 2016	Identical
GOST ISO 16037 : 2014	Identical
BIS IS/ISO 16037 : 2002 AMD 1 2015	Identical
NEN ISO 16037 : 2002 AMD 1 2011	Identical
NF ISO 16037 : 2002	Identical
DS ISO 16037 : 2002	Identical
SANS 16037 : 1ED 2003(R2008)	Identical

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

14/30296392 DC : 0	BS ISO 29943-1 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
16/30346829 DC : 0	BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT CONDOMS
12/30251858 DC : 0	BS ISO 4074 - NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS
BS ISO 29943-2 : 2017	CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 2: FEMALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
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
BS ISO 29943-1 : 2017	CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
ISO 29943-2 : 2017	CONDOMS - GUIDANCE ON CLINICAL STUDIES - GUIDANCE ON CLINICAL STUDIES - PART 2: FEMALE 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
ISO 23409 : 2011(R2015)	MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS
ISO 29943-1 : 2017	CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
ISO 16038 : 2017	MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT OF CONDOMS

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

ISO 10993-10 : 2010(R2016)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
ISO 10993-1 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
ISO 4074 : 2015	NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS
ISO 37 : 2017	RUBBER, VULCANIZED OR THERMOPLASTIC - DETERMINATION OF TENSILE STRESS-STRAIN PROPERTIES
ISO 14971 : 2007(R2010)	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES

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ISO 16037 : 2002(R2013)

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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