YY 0788-2010Ophthalmic instruments - Microkeratome (English PDF)

1 Scope

This standard specifies the classification, requirements, test methods, inspection rules, signs, instruction manuals, and packages for ophthalmic instruments.

Equipment, transportation and storage.

This standard applies to ophthalmic instruments micro-corneal knife (hereinafter referred to as micro-corneal knife), micro-corneal knife is mainly used for different levels of cornea

Refractive surgery and corneal transplantation.

This standard does not include requirements for blades.

2 normative reference documents

The terms of the following documents are hereby incorporated by reference in this standard as the terms of this standard, and any reference to the date,

The amendments (not including corrigenda) or revisions do not apply to this standard, however, the parties that encourage the agreement under this standard are

No use of the latest version of these files. For undated references, the latest edition applies to this standard.

GB/T 191-2008 Packaging and storage icon (ISO 780..1997, MOD)

GB/T 4340.1-2009 Metallic Vickers hardness test - Part 1. Test methods (ISO 6507-1..2005, MOD)

GB 4824-2004 Industrial, scientific and medical (ISM) RF equipment Electromagnetic disturbance characteristics Limits and methods of measurement (CISPR11.

2003, IDT)

GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)

General rules for the use of industrial products GB 9969.1-2008

Environmental requirements and test methods for medical appliances GB/T 14710-2009

GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and testing (ISO 10993-1..1997, IDT)

GB 17625.1-2003 Electromagnetic compatibility limits Harmonic current emission limits (input current per phase <= 16A) (IEC 61000-3-2..2001, IDT)

GB 17625.2-2007 Electromagnetic compatibility limit for each phase rated current <= 16A and unconditional access to the equipment in the common low voltage

Voltage variations in the power supply system, voltage fluctuations, and flicker limits

YY/T 0149-2006 Test method for corrosion resistance of stainless steel medical equipment (ISO 13401-5..2003, MOD)

Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. Generic requirements for medical devices YY/T 0466.1-2009 (ISO 15223-1..2007, IDT)

YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standard EMC requirements and tests (IEC 601-1-2..2001, IDT)

3 Classification and structure composition