ISO 16672:2015

Withdrawn

View Superseded by

Ophthalmic implants Ocular endotamponades

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

29-06-2020

Language(s)

French, English

Published date

07-08-2015

Publisher

International Organization for Standardization

ISO 16672:2015 applies to ocular endotamponades (OE), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.

With regard to the safety and efficacy of OE, this International Standard specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

DevelopmentNote	Supersedes ISO/DIS 16672. (08/2015)
DocumentType	Standard
Pages	14
PublisherName	International Organization for Standardization
Status	Withdrawn
SupersededBy	ISO 16672:2020
Supersedes	ISO 16672:2003

Standards	Relationship
NBN EN ISO 16672 : 2015	Identical
UNE-EN ISO 16672:2016	Identical
NEN EN ISO 16672 : 2015	Identical
NS EN ISO 16672 : 2003	Identical
I.S. EN ISO 16672:2015	Identical
PN EN ISO 16672 : 2015	Identical
SN EN ISO 16672 : 2016	Identical
UNI EN ISO 16672 : 2003	Identical
SS-EN ISO 16672 : 2015	Identical
UNI EN ISO 16672:2015	Identical
EN ISO 16672:2015	Identical
BS EN ISO 16672:2015	Identical
NF EN ISO 16672 : 2015	Identical
DIN EN ISO 16672:2015-12	Identical
ONORM EN ISO 16672 : 2015	Identical

ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 10993-2:2006	Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
EN ISO 14155:2011/AC:2011	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
EN ISO 13408-1:2015	Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
ISO 10993-2:2006	Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 11135-1:2007	Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 14630:2012	Non-active surgical implants General requirements
EN ISO 22442-1:2015	Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
ISO 13408-1:2008	Aseptic processing of health care products — Part 1: General requirements
ISO 20857:2010	Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
EN ISO 14971:2012	Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
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/AC:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
ISO 10993-6:2016	Biological evaluation of medical devices Part 6: Tests for local effects after implantation
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
EN ISO 14630:2012	Non-active surgical implants - General requirements (ISO 14630:2012)