Ophthalmic implants — Irrigating solutions for ophthalmic surgery

Amended by

ISO 16671:2015/Amd 1:2017

Available format(s)

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

Published date

07-08-2015

Publisher

International Organization for Standardization

ISO 16671:2015 defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.

ISO 16671:2015 applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

DevelopmentNote	Supersedes ISO/DIS 16671. (08/2015)
DocumentType	Standard
Pages	22
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO 16671:2003

Standards	Relationship
UNE-EN ISO 16671:2016	Identical
EN ISO 16671:2015/A1:2017	Identical
SN EN ISO 16671:2016	Identical
EN ISO 16671:2015	Identical
UNI EN ISO 16671:2018	Identical
I.S. EN ISO 16671:2015	Identical
UNI EN ISO 16671 : 2004	Identical
BS EN ISO 16671 : 2015	Identical
DIN EN ISO 16671:2015-12	Identical
NBN EN ISO 16671 : 2015	Identical
SN EN ISO 16671 : 2016 AMD 1 2018	Identical
NEN EN ISO 16671 : 2015 AMD 1 2017	Identical
ONORM EN ISO 16671 : 2018	Identical
PN EN ISO 16671 : 2015 AMD 1 2018	Identical
NS EN ISO 16671 : 2015 AMD 1 2017	Identical
NF EN ISO 16671 : 2015 AMD 1 2018	Identical

AAMI TIR19 : 1998	GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
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 22442-1:2015	Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
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 10993-7:2008	Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
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
EN ISO 14630:2012	Non-active surgical implants - General requirements (ISO 14630:2012)