ASTM F1078-10 (Reapproved 2011)

Standard Organization:

ASTM F1078-10 (Reapproved 2011)
Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades

Recognition Date2012-03-16
Recognition List028
Recognition Number6-269
Extent Complete standard
Standards Orgs ASTM ASTM International http://www.astm.org/
STG General Plastic Surgery/General Hospital
FDA Tech  Long Chen   FDA/OMPT/CDRH/ODE/DSD/GSDB2/   301-796-6389   long.chen@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

1.1 This terminology defines basic terms and considerations for the components of scissors with either inserted or non-inserted blades (see Fig. 1). Instruments in this terminology are limited to those fabricated having scissor blades made from stainless steel and used for surgical procedures.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§888.4540 Scissors, Orthopedic, Surgical Class 1 HRR
§880.6820 Scissors, Medical, Disposable Class 1 JOK
§878.4800 Scissors, General, Surgical Class 1 LRW
§872.4565 Scissors, Surgical Tissue, Dental Class 1 EGN

FDA Guidance:

There is no relevant guidance developed at this time.


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