14/30295067 DC : 0

Superseded

View Superseded by

BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY

Available format(s)

Hardcopy , PDF

Superseded date

31-08-2015

Language(s)

English

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

BS EN ISO 16671.

Committee	CH/172/7
DocumentType	Draft
Pages	31
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 16671 : 2015

AAMI TIR19 : 1998	GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
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 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
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
ISO 10993-6:2016	Biological evaluation of medical devices Part 6: Tests for local effects after implantation