YY/T 0072-2010General specification for ophthalmic knives (English PDF)

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.

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) […]