ISO 16037:2002
Current
The latest, up-to-date edition.
Rubber condoms for clinical trials Measurement of physical properties
PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
30-05-2002
This International Standard is intended as a guideline for clinical researchers working with condoms. It suggests a
series of laboratory tests to be conducted on the products to be used in any clinical investigation, so that it will be
easier to relate the clinical results to the design and quality of the condoms used.
This International Standard is not applicable to the design of clinical investigations.
DevelopmentNote |
Supersedes ISO/FDIS 16037 (06/2002)
|
DocumentType |
Standard
|
Pages |
5
|
PublisherName |
International Organization for Standardization
|
Status |
Current
|
Standards | Relationship |
NEN ISO 16037 : 2002 AMD 1 2011 | Identical |
GOST ISO 16037 : 2014 | Identical |
BIS IS/ISO 16037 : 2002 AMD 1 2015 | Identical |
NF ISO 16037 : 2002 | Identical |
08/30133979 DC : DRAFT MAY 2008 | BS ISO 23409 - 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 |
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 29943-1:2017 | Condoms. Guidance on clinical studies 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 |
14/30296392 DC : 0 | BS ISO 29943-1 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE 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 |
ISO 29943-2:2017 | Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports |
ISO 23409:2011 | Male condoms Requirements and test methods for condoms made from synthetic materials |
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 Female condoms, clinical function studies based on self-reports |
ISO 10993-10:2010 | 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 | Medical devices Application of risk management to medical devices |
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