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14/30295064 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES
Available format(s)

Hardcopy , PDF

Superseded date

08-31-2015

Language(s)

English

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 Integrity and performance of
   the delivery system
10 Packaging
11 Information supplied by the
   manufacturer
Annex A (normative) - Intraocular implantation test
Annex B (informative) - Clinical investigation
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC

BS EN ISO 16672.

Committee
CH/172/7
DocumentType
Draft
Pages
22
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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
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 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
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
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

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