ISO 14949:2001

Current

Current The latest, up-to-date edition.

Implants for surgery — Two-part addition-cure silicone elastomers

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

Language(s): English

Published date: 25-10-2001

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This International Standard specifies the characteristics of, and corresponding test methods for, the two-part

addition-cure high consistency or liquid silicone elastomer for use in the manufacture (partially or totally) of surgical

implants.

Committee	ISO/TC 150/SC 1
Development Note	Supersedes ISO/FDIS 14949 (09/2001)
Document Type	Standard
ISBN
Pages
Published
Publisher	International Organization for Standardization
Status	Current

BS ISO 12891-2:2014	Retrieval and analysis of surgical implants Analysis of retrieved surgical implants
13/30242622 DC : 0	BS ISO 12891-2 - RETRIEVAL AND ANALYSIS OF SURGICAL IMPLANTS - PART 2: ANALYSIS OF RETRIEVED SURGICAL IMPLANTS
ISO 12891-2:2014	Retrieval and analysis of surgical implants Part 2: Analysis of retrieved surgical implants

ISO 34-1:2015	Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent test pieces
ISO 6502:2016	Rubber Guide to the use of curemeters
ISO 527-2:2012	Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 48:2010	Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 3417:2008	Rubber Measurement of vulcanization characteristics with the oscillating disc curemeter

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This International Standard specifies the characteristics of, and corresponding test methods for, the two-part

addition-cure high consistency or liquid silicone elastomer for use in the manufacture (partially or totally) of surgical

implants.

Committee	ISO/TC 150/SC 1
Development Note	Supersedes ISO/FDIS 14949 (09/2001)
Document Type	Standard
ISBN
Pages
Published
Publisher	International Organization for Standardization
Status	Current

BS ISO 12891-2:2014	Retrieval and analysis of surgical implants Analysis of retrieved surgical implants
13/30242622 DC : 0	BS ISO 12891-2 - RETRIEVAL AND ANALYSIS OF SURGICAL IMPLANTS - PART 2: ANALYSIS OF RETRIEVED SURGICAL IMPLANTS
ISO 12891-2:2014	Retrieval and analysis of surgical implants Part 2: Analysis of retrieved surgical implants

ISO 34-1:2015	Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent test pieces
ISO 6502:2016	Rubber Guide to the use of curemeters
ISO 527-2:2012	Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 48:2010	Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 3417:2008	Rubber Measurement of vulcanization characteristics with the oscillating disc curemeter