OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY

Amended by

BS EN ISO 16671:2015+A1:2017

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Publisher

British Standards Institution

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
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
Bibliography

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	CH/172/7
DevelopmentNote	Supersedes 02/560790 DC. (12/2003) Supersedes 14/30295067 DC. (09/2015) Supersedes 17/30351468 DC. 2015 Edition Re-Issued in January 2018 & incorporates AMD 1 2017. (01/2018)
DocumentType	Standard
Pages	34
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN ISO 16671:2003 17/30351468 DC : 0 14/30295067 DC : 0 02/560790 DC : DRAFT FEB 2002

Standards	Relationship
DIN EN ISO 16671:2015-12	Identical
NBN EN ISO 16671 : 2015	Identical
UNE-EN ISO 16671:2016	Identical
ISO 16671:2015	Identical
EN ISO 16671:2015/A1:2017	Identical
I.S. EN ISO 16671:2015	Identical
UNI EN ISO 16671 : 2004	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
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)

View more information

US$261.13

Excluding Tax where applicable

Product format

I agree to the DRM document license rules apply against the PDF selection made.

Please confirm that you agree to the document license rules for this document.

I agree to the document license rules .

Please confirm that you agree to the document license rules for this document.

Access your standards online with a subscription

Features

Simple online access to standards, technical information and regulations.
Critical updates of standards and customisable alerts and notifications.
Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

Get in touch with us

Log into your Account

BS EN ISO 16671 : 2015

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

Access your standards online with a subscription