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AAMI TIR11:2005(R2015)

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES
Available format(s)

Hardcopy , PDF

Superseded date

06-27-2023

Language(s)

English

Published date

10-21-2015

Glossary of equivalent standards
Committee representation
Acknowledgments
Foreword
1 Introduction and scope
2 Definitions of terms
3 Types of surgical protective materials
  3.1 Introduction
  3.2 Multiple-use materials
       3.2.1 General considerations
       3.2.2 Historical materials
       3.2.3 Current materials
  3.3 Single-use materials
  3.4 Reinforcement of multiple-use and single-use products
4 Safety and performance characteristics
  4.1 Introduction
  4.2 Barrier effectiveness
       4.2.1 Resistance to liquid and microbial penetration
       4.2.2 Resistance to penetration by airborne,
             aerosol-borne, or dry particles
  4.3 Abrasion resistance
  4.4 Strength
       4.4.1 General considerations
       4.4.2 Breaking strength
       4.4.3 Tear strength
       4.4.4 Puncture and tear resistance
  4.5 Drapeability
  4.6 Comfort
  4.7 Staining, discoloration, and residues
  4.8 Electrostatic properties
  4.9 Flammability
  4.10 Generation of particulates and visible lint
  4.11 Shrinkage
  4.12 Biocompatibility
  4.13 Sterility assurance
  4.14 Performance in use
  4.15 Strike-through investigation
5 Product evaluation and selection of protective
  apparel and surgical drapes
  5.1 Introduction
  5.2 Information from manufacturers and suppliers
  5.3 Product evaluation
  5.4 Cost comparisons
  5.5 Staff input
  5.6 Performance priorities in relation to product
       function
  5.7 Periodic reassessment
6 Guidelines for choosing levels of barrier
  performance needed for particular health care
  applications
  6.1 Introduction
  6.2 Exposure control plan
  6.3 Classification and labeling of barrier
       performance by manufacturers
  6.4 Examples of possible barrier performance
       levels for particular applications
  6.5 Special considerations for isolation gowns
7 Care and handling of protective apparel and
  surgical drapes
  7.1 Introduction
  7.2 General considerations
  7.3 Handling of contaminated protective apparel
       and surgical drapes at the point of use
  7.4 Disposal of single-use products
  7.5 Processing of multiple-use products
       7.5.1 Quality assurance program
       7.5.2 Tracking the number of uses
       7.5.3 Laundering
       7.5.4 Inspection, testing, folding, and assembly
Annexes
A - Historical background
B - Test methods
C - Bibliography

Covers selection and use of protective apparel and surgical drapes, including information on types of protective materials, safety and performance characteristics of protective materials, product evaluation and selection, choosing the level of barrier performance and care of protective apparel and drapes.

Committee
PB
DocumentType
Revision
ISBN
1–57020–241–9
Pages
50
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

TAPPI T 547 : 2012 AIR PERMEANCE OF PAPER AND PAPERBOARD (SHEFFIELD METHOD)
ASTM D 5733 : 1999 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure (Withdrawn 2008)
ISO 13934-1:2013 Textiles — Tensile properties of fabrics — Part 1: Determination of maximum force and elongation at maximum force using the strip method
AAMI ST41 : 2008 ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
ISO 13934-2:2014 Textiles Tensile properties of fabrics Part 2: Determination of maximum force using the grab method
ISO 9073-4:1997 Textiles Test methods for nonwovens Part 4: Determination of tear resistance
EN 20811 : 1992 TEXTILES - DETERMINATION OF RESISTANCE TO WATER PENETRATION - HYDROSTATIC PRESSURE TEST
CFR 16(PTS1000-END) : 0 COMMERCIAL PRACTICES - FEDERAL TRADE COMMISSION - CONSUMER PRODUCT SAFETY COMMISSION
ISO 9073-7:1995 Textiles — Test methods for nonwovens — Part 7: Determination of bending length
ASTM F 1342 : 2005 Standard Test Method for Protective Clothing Material Resistance to Puncture
AAMI ST65:2008(R2018) PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
ISO 9073-9:2008 Textiles Test methods for nonwovens Part 9: Determination of drapability including drape coefficient
ISO 22612:2005 Clothing for protection against infectious agents Test method for resistance to dry microbial penetration
BS 6909:1988 Method for generation and counting of the airborne linting propensity of fabrics in the dry state
NFPA 99 : 2018 HEALTH CARE FACILITIES CODE
CFR 29(PT1910.1000 TO END) : 0 LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
ASTM F 2101 : 2014 : REDLINE TEST METHOD FOR EVALUATING THE BACTERIAL FILTRATION EFFICIENCY (BFE) OF MEDICAL FACE MASK MATERIALS, USING A BIOLOGICAL AEROSOL OF STAPHYLOCOCCUS AUREUS
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 11092:2014 Textiles — Physiological effects — Measurement of thermal and water-vapour resistance under steady-state conditions (sweating guarded-hotplate test)
NFPA 702 : 1993 RECOMMENDED PRACTICE FOR A FIELD MATCH FLAME TEST FOR TEXTILES AND FILMS
ISO 9073-10:2003 Textiles Test methods for nonwovens Part 10: Lint and other particles generation in the dry state
ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
ASTM F 1868 : 2017 : REDLINE Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
ASTM D 2582 : 2016 : REDLINE Standard Test Method for Puncture-Propagation Tear Resistance of Plastic Film and Thin Sheeting
ANSI/AAMI PB70:2012 LIQUID BARRIER PERFORMANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CARE FACILITIES
ASTM D 737 : 2004 Test Method for Air Permeability of Textile Fabrics

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