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ANSI Z80.27 : 2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

OPHTHALMICS - IMPLANTABLE GLAUCOMA DEVICES
Available format(s)

Hardcopy , PDF

Superseded date

02-18-2020

Language(s)

English

Published date

01-01-2014

Foreword
1 Scope and purpose
2 Normative references
3 Definitions
4 Design attributes and evaluation
5 Physical and mechanical requirements
6 Biocompatiblity requirements
7 Sterility/package integrity requirements
8 Shelf-life and transport stability requirements
9 Additional requirements
10 Clinical evaluation
11 Labeling
Annexes
Annex A (informative) - Examples of practices for in-Vitro
        flow characteristics of aqueous shunt type of implantable
        glaucoma devices
Annex B (informative) - Ocular implantation test
Annex C (informative) - Guidance on clinical study
        design for implantable glaucoma devices with
        refractory glaucoma indications
Annex D (informative) - Guidance on clinical study design
        for implantable glaucoma devices with nonrefractory
        glaucoma indications
Annex E (informative) - Evaluations, Methodology and Adverse events
Annex F (informative) Statistical Sample Size Considerations for
        nonrefractory glaucoma devices
Annex G (informative) - Recommended Analyses of Data from
        the Clinical Investigation
Annex H (informative) - Labeling for Implantable Glaucoma
        devices
Annex I (informative) - Bibliography

Pertains to devices that are implanted in the eye to treat glaucoma by facilitating aqueous outflow. The standard excludes glaucoma devices whose effect depends upon metabolic and/or pharmacologic mechanisms.

DocumentType
Standard
Pages
49
PublisherName
Optical Laboratories Association
Status
Superseded
SupersededBy

AAMI ISO 11134 : 1ED 93 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - INDUSTRIAL MOIST HEAT STERILIZATION
ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ASTM D 4169 : 2016 : REDLINE Standard Practice for Performance Testing of Shipping Containers and Systems
ANSI/AAMI/ISO 11135:2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 14630:2012 Non-active surgical implants General requirements
ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 11979-5:2006 Ophthalmic implants Intraocular lenses Part 5: Biocompatibility
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping
ISO 11979-6:2014 Ophthalmic implants Intraocular lenses Part 6: Shelf-life and transport stability testing
ISO 8318:2000 Packaging Complete, filled transport packages and unit loads Sinusoidal vibration tests using a variable frequency

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