Name: EN ISO 16671:2015/A1:2017
Brand: CEN

OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015/AMD 1:2017)

Published date

11-22-2017

Publisher

Comite Europeen de Normalisation

European foreword
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Design evaluation
7 Sterilization
8 Product stability
9 Packaging
10 Information supplied by the manufacturer
Annex A (informative) - Example of a suitable method
        for pH measurement and buffer capacity determination
Annex B (normative) - Particulate contamination: Visible
        particulates
Annex C (informative) - Light obscuration test method for
        particulate contamination: sub-visible particles
Annex D (informative) - Microscopic test method for particulate
        contamination: sub-visible particles
Annex E (normative) - Intraocular irrigation test
Annex F (informative) - Clinical investigation
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         93/42/EEC

Specifies 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.

Committee	TC 170
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current
Supersedes	EN ISO 16671:2015

Standards	Relationship
BS EN ISO 16671 : 2015	Identical
ONORM EN ISO 16671 : 2018	Identical
NEN EN ISO 16671 : 2015 AMD 1 2017	Identical
PN EN ISO 16671 : 2015 AMD 1 2018	Identical
SN EN ISO 16671 : 2016 AMD 1 2018	Identical
UNE-EN ISO 16671:2016	Identical
ISO 16671:2015	Identical
NF EN ISO 16671 : 2015 AMD 1 2018	Identical
I.S. EN ISO 16671:2015	Identical
NS EN ISO 16671 : 2015 AMD 1 2017	Identical
UNI EN ISO 16671 : 2004	Identical
DIN EN ISO 16671:2015-12	Identical
NBN EN ISO 16671 : 2015	Identical
ISO 16671:2015/Amd 1:2017	Identical
I.S. EN ISO 16671:2015&A1:2017	Identical
DIN EN ISO 16671:2018-03	Identical
BS EN ISO 16671:2015+A1:2017	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)