YY/T 0072-2010 English PDF (YYT0072-2010)

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YY/T 0072-2010: General specification for ophthalmic knives
YY/T 0072-2010
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.30
C 31
Replacing YY 0072-1992
General specification for ophthalmic knives
ISSUED ON. DECEMBER 27, 2010
IMPLEMENTED ON. JUNE 01, 2012
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Materials... 5
4 Requirements... 5
5 Test method... 6
6 Inspection rules... 6
7 Marking... 8
8 Packaging, transportation, storage... 8
Appendix A (Normative) Test method for the cutting edge sharpness of ophthalmic
knife... 10
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0072-1992 "General technical requirements for ophthalmic
scalpel".
The differences between this standard and YY 0072-1992 are as follows.
- DELETE the small rectangular handle type;
- MODIFY the edge sharpness test method;
- ADD the material designations.
Appendix A of this standard is a normative appendix.
This standard was proposed by and shall be under the jurisdiction of the National
Technical Committee for Standardization of Surgical Instruments (SAC/TC 94).
The main drafting organization of this standard. Suzhou Liuliu Vision Technology Co.,
Ltd.
The main drafters of this standard. Zhang Jianping, Hang Zhaoyuan.
This standard replaces the standard previously issued as follows.
- WS2-71~72-1964;
- WS2-101-1974;
- YY 0072-1992.
General specification for ophthalmic knives
1 Scope
This standard specifies the materials, requirements, test methods, inspection rules,
marking, packaging, transportation, storage and other requirements for ophthalmic
knives.
This standard applies to ophthalmic knives made of stainless steel (hereinafter referred
to as ophthalmic knives).
2 Normative references
The following documents are essential to the application of this document. For the dated
documents, only the versions with the dates indicated are applicable to this document;
for the undated documents, only the latest version (including all the amendments) is
applicable to this standard.
GB/T 1220-2007 Stainless steel rod
GB/T 2828.1-2003 Sampling procedures for inspection by attributes - Part 1.
Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot
inspection (AQL) (ISO 2859-1.1999, IDT)
GB/T 2829-2002 Sampling procedures and tables for periodic inspection by
attributes (apply to inspection of process stability)
GB/T 4340.1-2009 Metallic materials - Vickers hardness test - Part 1.Test method
(ISO 6507-1.2005, MOD)
YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion
resistance (ISO 13401.1995, MOD)
YY 0167-2005 Non-absorbable surgical suture
YY/T 1052-2004 Marking requirements for surgical instruments
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1.General requirements (YY/T
0466.1-2009, ISO 15223-1.2007, IDT)