ANSI Z80.27 : 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
English
01-01-2014
18-02-2020
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 |
Vision Council
|
| Status |
Superseded
|
| 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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