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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 10-128
Standard
ASTM D882-18
Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
Scope/Abstract
1.1 This test method covers the determination of tensile properties of plastics in the form of thin sheeting and films (less than 1.0 mm (0.04 in.) in thickness).
Note 1: Film is defined in Terminology D883 as an optional term for sheeting having a nominal thickness no greater than 0.25 mm (0.010 in.).
Note 2: Tensile properties of plastics 1.0 mm (0.04 in.) or greater in thickness shall be determined according to Test Method D638.

1.2 This test method can be used to test all plastics within the thickness range described and the capacity of the machine employed.

1.3 Specimen extension can be measured by grip separation, extension indicators, or displacement of gage marks.

1.4 The procedure for determining the tensile modulus of elasticity is included at one strain rate.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ASTM D882-12 [Rec# 10-87] will be superseded by recognition of ASTM D882-18 [Rec# 10-128]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-87] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 10-87] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.5925 Lens, Contact, (Disposable) Class 2 MVN
§886.5925 Lenses, Soft Contact, Daily Wear Class 2 LPL
§886.5925 Lenses, Soft Contact, Extended Wear Class 3 LPM
Relevant FDA Guidance and/or Supportive Publications*
Premarket Notification (510k) Guidance Document for Daily Wear Contact Lenses, Issued May 1994.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Joseph C. Hutter
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6499
  joseph.hutter@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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