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Surgical instrument standards and scope of application
1970-01-01

Professional general field
1、Standard number:YY/T 0076-1992
Standard name:Technical conditions for classification of plating layers of metal parts
Scope of application: This standard specifies the classification of medical device plating layer, the scope of application, technical requirements, acceptance rules, inspection methods and marking requirements. This standard applies to the metal parts of the protective decorative single-layer (nickel, chromium, zinc, tin, silver, gold, cadmium, black nickel) plating and multi-layer (nickel + chromium, nickel + nickel + chromium, copper + nickel + complex, copper-tin alloy ten chromium) plating.
Note: This standard was officially implemented on July 1, 1992.
2、Standard number:YY/T 0149-2006
Standard name: stainless steel medical instruments corrosion resistance test method
Scope of application: This standard specifies the martensitic and austenitic stainless steel medical instruments and dental hand-held instruments corrosion resistance test method. This standard applies to martensitic stainless steel medical instruments (such as scissors, pliers, forceps and other instruments), austenitic stainless steel medical instruments (such as injection needles, acupuncture needles, stainless steel intrauterine device, dental stainless steel wire, etc.) also applies to the manufacture of austenitic stainless steel medical instruments materials. This standard does not apply to martensitic austenitic stainless steel surgical implants.
Note: This standard was officially implemented on May 1, 2007.
3、Standard number:YY/T 0171-2008
Standard name: surgical instruments packaging, marking and instructions for use
Scope of application: This standard specifies the packaging of surgical instruments, signs and instructions for use. This standard applies to the general packaging of surgical instruments products, sterile packaging and sterile packaging.
Note: This standard was officially implemented on January 1, 2010.
4、Standard number:YY/T 0294.1-2016
Standard name: surgical instruments metal materials Part 1: stainless steel
Scope of application: YY/T 0294 of this part of the content for the design, manufacture of surgical instruments when choosing stainless steel materials. Note: In the manufacture of surgical instruments selected stainless steel materials, such as instrument design needs, allow the selection of materials outside this part, so the contents of this part is not the only basis for the selection of manufacturing materials. Manufacturers in the selection of stainless steel materials, should also consider the material in line with the relevant surgical instrument standards, and should be responsible for the materials selected.
Note: This standard was officially implemented on January 1, 2017.
5、Standard number:YY/T 1052-2004
Standard name: surgical instrument markings
Scope of application: This standard specifies the scope of application, marking examples and requirements for surgical instrument markings. This standard applies to surgical instrument markings. This standard does not apply to surgical implant signs.
Note: This standard was officially implemented on November 1, 2005.

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