ISO 16038:2005
Rubber condoms - Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms
- Standard No.
- ISO 16038:2005
- Release Date
- 2005
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 16038:2017
- Latest
- ISO 16038:2017
- Scope
- This International Standard provides guidance on using ISO 4074 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 design, manufacture and delivery of condoms with emphasis on performance, safety and reliability of condoms.
ISO 16038:2005 Referenced Document
- ISO 14155-1 Clinical investigation of medical devices for human subjects - Part 1: General requirements
- ISO 14155-2 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
- ISO 2859-1 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection; Technical Corrigendum 1
- ISO 31-0:1992 Quantities and units; part 0: general principles
- ISO 4074:2002 Natural latex rubber condoms - Requirements and test methods
- ISO 9000 Quality management systems - Fundamentals and vocabulary [French version]*， 2015-09-15 Update
ISO 16038:2005 history
- 2017 ISO 16038:2017 Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
- 2005 ISO 16038:2005 Rubber condoms - Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms
