We need your consent to use the individual data so that you can see information about your interests, among other things. Click "OK" to give your consent.
Standard Specification for Soft-Tissue Expander Devices
STANDARD published on 10.4.2003
Designation standards: ASTM F1441-03
Note: WITHDRAWN
Publication date standards: 10.4.2003
SKU: NS-50306
The number of pages: 5
Approximate weight : 15 g (0.03 lbs)
Country: American technical standard
Category: Technical standards ASTM
Keywords:
elastomer, expander, implant, implant material, medical device, plastic surgery, soft tissue expander, ICS Number Code 85.100 (Equipment for the paper industry)
1. Scope | ||||||||||||||||||
1.1 This specification covers the requirements for single use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed. 1.2 Limitations: 1.2.1 This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification. 1.2.2 This specification applies, in part, to combination "expander/mammary" devices as classified in Section 4. 1.3 The values stated in SI units are to be regarded as standard, values in parentheses are for information only. 1.4 The following statement pertains only to the test methods and requirements portion, Section 9, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. |
||||||||||||||||||
2. Referenced Documents | ||||||||||||||||||
|
Do you want to make sure you use only the valid technical standards?
We can offer you a solution which will provide you a monthly overview concerning the updating of standards which you use.
Would you like to know more? Look at this page.
Latest update: 2024-09-25 (Number of items: 2 350 354)
© Copyright 2024 NORMSERVIS s.r.o.