YY 0788-2010 English PDF

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YY 0788-2010: Ophthalmic instruments. Microkeratome
Status: Obsolete

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0788-2010	399	Add to Cart	3 days	Ophthalmic instruments. Microkeratome	Obsolete

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Basic data

Standard ID: YY 0788-2010 (YY0788-2010)
Description (Translated English): Ophthalmic instruments. Microkeratome
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C40
Classification of International Standard: 11.040.70
Word Count Estimation: 10,179
Date of Issue: 2010-12-27
Date of Implementation: 2012-06-01
Quoted Standard: GB/T 191-2008; GB/T 4340.1-2009; GB 4824-2004; GB 9706.1-2007; GB 9969.1-2008; GB/T 14710-2009; GB/T 16886.1-2001; GB 17625.1-2003; GB 17625.2-2007; YY/T 0149-2006; YY/T 0466.1-2009; YY 0505-2005
Regulation (derived from): State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the Ophthalmic instruments microkeratome product classification, requirements, test methods, inspection rules, signs, instructions, packaging, transport and storage. This standard applies to Ophthalmic instruments microkeratome (hereinafter referred to as microkeratome), microkeratome is mainly used for different levels of corneal refractive surgery and corneal transplants. This standard does not include requirements on the blade.

YY 0788-2010: Ophthalmic instruments. Microkeratome

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Ophthalmic instruments.Microkeratome ICS 11.040.70 C40 People's Republic of China Pharmaceutical Industry Standard Ophthalmic instruments microkerchief knife 2010-12-27 release 2012-06-01 implementation State Food and Drug Administration issued

Foreword

The implementation of this standard GB 9706.1-2007 "Medical electrical equipment Part 1. General requirements for safety", YY 0505-2005 "Medical Electrical equipment - Part 1-2. Safety - General requirements - Parallel standard EMC requirements and tests) and GB/T 16886.1-2001 "Biological evaluation of medical devices Part 1. Evaluation and testing" and other standards. Appendix A of this standard is a normative appendix. The test method in Appendix A is a recommended method. This standard is proposed and assigned by the National Standardization Subcommittee for Medical Optics and Instruments (SAC/TC103/SC1). This standard by the Wuxi City Kangming Medical Devices Co., Ltd. is responsible for drafting. The main drafters of this standard. Zhang Baohua, Chu Renyuan, Luo Yinhe, Zhou Xingtao, Wang Shifen, Hu Ruo rope. Ophthalmic instruments microkerchief knife

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

3.1 Classification 3.1.1 according to the movement, classified in Table 1. ......

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