YY 0674-2008Ophthalmic instruments - Phoropters (English PDF)
眼科仪器 验光头
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
October 17, 2008
Implementation date
June 1, 2010
Scope
YY 0674-2008 is the English-translated version of 眼科仪器 验光头.
YY 0674-2008 is the Chinese standard "Ophthalmic instruments - Phoropters". Its scope clause reads: This standard gives requirements and test methods for measuring the human eye binocular vision and refractive errors optometry head. Its clauses include terms and definitions.
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Document preview — YY 0674-2008
National Standard of the People's Republic of China
- ICS
- 11.040.70
- Classification
- C40
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
1 Scope
This standard gives requirements and test methods for measuring the human eye binocular vision and refractive errors optometry head.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB 9706.1 Medical Electrical Equipment Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601. 1988, IDT)
GB/T 10050-1988 and optical equipment reference wavelength (eqv ISO 7944. 1984)
GB/T 14710-1993 Medical electrical equipment environmental requirements and test methods
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests (ISO 10993-5.1999,
IDT)
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test (ISO 10993-10.2002, IDT)
ISO 8429. 1986 Optics and optical instruments - Ophthalmology dial
ISO 15004.1997 ophthalmic instruments basic requirements and test methods
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
To provide spherical lenses, cylinder lenses and a prism sheet and other optics equipment can be placed in front of people measure the patient's binocular vision and Qu
Light errors.
3.2
Head for measuring the refraction power of tolerance of positioning plane.
3.3
Optometry head reference plane and the distance between the corneal vertex.
3.4
The intersection of the optical axis of the lens on the lens surface.
3.5
Lenses and optical surfaces by changing the curvature or refraction through the ability to change the direction of the incident surface.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 10050-1988Optics and optical instruments -- Reference wavelengths
- GB/T 14710-1993The environmental requirement and test methods for medical electrical equipment
- GB/T 16886.5-2003Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- GB/T 16886.10-2005Biological evaluation of medical devices - Part 10: Tests for skin sensitization
IEC 60601 · ISO 7944 · ISO 10993 · ISO 8429 · ISO 15004.1997
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Related Standards
GB 9706.1-2007 — Medical electrical equipment - Part 1: General requirements for safety
GB/T 10050-1988 — Optics and optical instruments--Reference wavelengths
GB/T 14710-1993 — The environmental requirements and test methods for medical electrical equipment
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YY 0674-2008
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