IEST RP-CC005 4-2013 GLOVES AND FINGER COTS USED IN CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS.pdf

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1、Institute of Environmental Sciences and Technology IEST-RP-CC005.4 Contamination Control Division Recommended Practice 005.4 Gloves and Finger Cots Used in Cleanrooms and Other Controlled Environments Arlington Place One 2340 S. Arlington Heights Road, Suite 620 Arlington Heights, IL 60005-4510 Phon

2、e: (847) 981-0100 Fax: (847) 981-4130 E-mail: informationiest.org Web: www.iest.org 2 IEST 2013 All rights reserved Institute of Environmental Sciences and Technology IEST-RP-CC005.4 This Recommended Practice is published by the Institute of Environmental Sciences and Technology to advance the techn

3、ical and engineering sciences. Use of this document is entirely voluntary, and determination of its applicability and suitability for any particular use is solely the responsibility of the user. Use of this Recommended Practice does not imply any warranty or endorsement by IEST. This Recommended Pra

4、ctice was prepared by and is under the jurisdiction of Working Group 005 of the IEST Contamination Control Division. Copyright 2013 by the Institute of Environmental Sciences and Technology First printing, October 2013 ISBN 978-1-937280-02-4 PROPOSAL FOR IMPROVEMENT: The Working Groups of the Instit

5、ute of Environmental Sciences and Technology are continually working on improvements to their Recommended Practices and Reference Documents. Suggestions from users of these documents are welcome. If you have a suggestion regarding this document, please use the online Proposal for Improvement form fo

6、und on the IEST website at www.iest.org. Institute of Environmental Sciences and Technology Arlington Place One 2340 S. Arlington Heights Road, Suite 620 Arlington Heights, IL 60005-4510 Phone: (847) 981-0100 Fax: (847) 981-4130 E-mail: informationiest.org Web: www.iest.org IEST-RP-CC005.4 Institute

7、 of Environmental Sciences and Technology IEST 2013 All rights reserved 3 Gloves and Finger Cots Used in Cleanrooms and Other Controlled Environments IEST-RP-CC005.4 CONTENTS SECTION 1 SCOPE AND LIMITATIONS 5 2 REFERENCES . 5 3 TERMS AND DEFINITIONS 8 4 BACKGROUND AND PURPOSE 10 5 PHYSICAL CHARACTER

8、ISTICS OF GLOVES AND FINGER COTS . 10 6 TENSILE PROPERTIES 10 7 CUT RESISTANCE . 10 8 ABRASION RESISTANCE . 11 9 CHEMICAL COMPATIBILITY . 11 10 BARRIER INTEGRITY . 11 11 BONDING OF A BARRIER PALM TO A KNITTED OR WOVEN GLOVE . 11 12 RESISTANCE TO HEAT 11 13 AGING . 12 14 OUTGASSING . 12 15 STATIC CHA

9、RGE . 12 16 PARTICLE RELEASE . 12 17 EXTRACTABLE MATTER 15 18 ASHING . 18 19 HYDROGEN SULFIDE 18 20 MICROORGANISMS 18 21 CORROSION OF SURFACES CAUSED BY CONTACT WITH GLOVES AND FINGER COTS . 20 APPENDIX A DETERMINATION OF GLOVE OR FINGER COT AREA (WEIGHT METHOD) 21 B METHOD FOR CLEARING CELLULOSE FI

10、LTERS 22 4 IEST 2013 All rights reserved Institute of Environmental Sciences and Technology IEST-RP-CC005.4 IEST-RP-CC005.4 Institute of Environmental Sciences and Technology IEST 2013 All rights reserved 5 Institute of Environmental Sciences and Technology Contamination Control Division Recommended

11、 Practice 005.4 Gloves and Finger Cots Used in Cleanrooms and Other Controlled Environments IEST-RP-CC005.4 1 SCOPE AND LIMITATIONS 1.1 Scope This Recommended Practice (RP) describes procedures for testing and evaluating gloves and finger cots used in cleanrooms and other controlled environments. Te

12、sts are provided for determining cleanliness, physical and chemical integrity, and other relevant properties. Guidelines are also provided to assist users in the proper selection of gloves or finger cots. 1.2 Limitations It is impractical to design and manufacture gloves or finger cots to meet all r

13、equirements of every application. Therefore, the user should base the selection of gloves and finger cots on the requirements of the process, the analytical data resulting from evaluation testing, and the product data provided by the manufacturer. The application for which a glove is intended should

14、 determine which tests are appropriate and relevant. 2 REFERENCES The cited editions of the following documents are incorporated into this RP to the extent specified herein. Users are encouraged to investigate the possibility of applying the most recent editions of the references. 2.1 Applicable doc

15、uments ANSI/AAMI/ISO 11737-1:2006/(R) 2011: Sterilization of health care productsMicrobiological methodsPart 1: Determination of the population of microorganisms on product ANSI/AAMI ST72:2011: Bacterial Endotoxins Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing. ANSI/ESD S

16、TM11.12-2007: Volume Resistance Measurement of Static Dissipative Planar Materials ANSI/ISEA 105-2011: American National Standard for Hand Protection Selection Criteria. Appendix B, “Test Method for Chemical Degradation Resistance” ASTM D130-10: Standard Test Method for Corrosiveness to Copper from

17、Petroleum Products by Copper Strip Test ASTM D297-93(2006): Standard Test Methods for Rubber ProductsChemical Analysis ASTM D412-06ae2: Standard Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension 6 IEST 2013 All rights reserved Institute of Environmental Sciences and Technology I

18、EST-RP-CC005.4 ASTM D413-98 (2007): Standard Test Methods for Rubber PropertyAdhesion to Flexible Substrate ASTM D471-06e1: Standard Test Method for Rubber PropertyEffect of Liquids ASTM D573-04(2010): Standard Test Method for RubberDeterioration in an Air Oven ASTM D1349-09: Standard Practice for R

19、ubberStandard Temperatures for Testing ASTM D2420-07: Standard Test Method for Hydrogen Sulfide in Liquified Petroleum (LP) Gases (Lead Acetate Method) ASTM D3389-10: Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader) ASTM D3577-09e1: Standard Specification for Rub

20、ber Surgical Gloves ASTM D3578-05(2010): Standard Specification for Rubber Examination Gloves ASTM D3767-03(2008): Standard Practice for RubberMeasurement of Dimensions ASTM D3772-01(2010): Standard Specification for Natural Rubber Finger Cots ASTM D4966-98(2007)e1: Standard Test Method for Abrasion

21、 Resistance of Textile Fabrics (Martindale Abrasion Tester Method) ASTM D5151-06(2011): Standard Test Method for Detection of Holes in Medical Gloves ASTM D5250-06e1: Standard Specification for Poly(vinyl chloride) Gloves for Medical Application ASTM D6319-10: Standard Specification for Nitrile Exam

22、ination Gloves for Medical Application ASTM E595-07: Standard Test Method for Total Mass Loss and Collected Volatile Condensable Materials from Outgassing in a Vacuum Environment ASTM F311-08: Standard Practice for Processing Aerospace Liquid Samples for Particulate Contamination Analysis Using Memb

23、rane Filters ASTM F312-08: Standard Test Methods for Microscopical Sizing and Counting Particles from Aerospace Fluids on Membrane Filters ASTM F739-07: Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact ASTM F1060-08

24、: Standard Test Method for Thermal Protective Performance of Materials for Protective Clothing for Hot Surface Contact ASTM F1790-05: Standard Test Method for Measuring Cut Resistance of Materials Used in Protective Clothing California Code of Regulations. Title 8, Section 3407. Hand and Wrist Prote

25、ction. Subchapter 7. General Industry Safety Orders. Group 2. Safe Practices and Personal Protection. Article 10.1. Personal Protective Clothing and Equipment for Fire Fighters. California Division of Occupational Safety and Health (Cal/OSHA) Federal Test Method Standard 191A: Federal Standard for T

26、extile Test Methods. “Method 5903.2: Textile Test Methods” (Available from GSA) IEST-RP-CC022.2: Electrostatic Charge in Cleanrooms and Other Controlled Environments IEST-STD-CC1246E: Product Cleanliness Levels Applications, Requirements, and Determination ISO 14644-1: Cleanrooms and associated cont

27、rolled environmentsPart 1: Classification of air cleanliness MIL-STD-168B: Visual Inspection Guide for All-Rubber Gloves Except Surgical. (Available from DODSSP) United States Pharmacopeia (USP) Chapter : “Bacterial Endotoxins Test” IEST-RP-CC005.4 Institute of Environmental Sciences and Technology

28、IEST 2013 All rights reserved 7 2.2 Sources AAMI Association for the Advancement of Medical Instrumentation (For standards and publications orders) PO Box 0211 Annapolis Junction, MD 20701-0211 Phone: 877-249-8226 Fax: 240-396-5781 Website: www.aami.org ANSI American National Standards Institute 25

29、West 43rd Street New York, NY 10036 Phone: 212-642-4900 Fax: 212-398-0023 E-mail: infoansi.org Website: www.ansi.org ASTM International 100 Barr Harbor Drive West Conshohocken, PA 19428-2959 Phone: 610-832-9585 Fax: 610-832-9555 E-mail: serviceastm.org Website: www.astm.org CA OSHA California Occupa

30、tional Safety and Health Administration 2211 Park Towne Circle, Suite 4 Sacramento, CA 95825 Tel: (916) 574-2528 Fax: (916) 574-2532 E-mail: DOSHEducationdir.ca.gov Website: www.dir.ca.gov/dosh/PubOrder.asp DODSSP Database for Military Specifications and Military Standards Building 4, Section D 700

31、Robbins Avenue Philadelphia, PA 19111-5098 Phone: 215 697-6396 Website: http:/www.assist.dla.mil ESDA Electrostatic Discharge Association 7900 Turin Road, Building 3 Rome, NY 13440-2069 Phone: 315-339-6937 Fax: 315-339-6793 E-mail: infoesda.org Website: www.esda.org 8 IEST 2013 All rights reserved I

32、nstitute of Environmental Sciences and Technology IEST-RP-CC005.4 GSA General Services Administration Specifications Activity Materials Supply Division, Building 197 Naval Weapons Plant Washington, D.C. 20407 Website: apps.fas.gsa.gov/pub/fedspecs IEST Institute of Environmental Sciences and Technol

33、ogy Arlington Place One 2340 South Arlington Heights Road, Suite 620 Arlington Heights, IL 60005-4510 Phone: 847-981-0100 Fax: 847- 981-4130 Website: www.iest.org ISEA The International Safety Equipment Association 1901 North Moore Street Arlington, VA 22209-1762 Phone: 703-525-1695 Fax: 703-528-214

34、8 Website: www.safetyequipment.org ISO In US, documents may be ordered from: Institute of Environmental Sciences and Technology Arlington Place One 2340 South Arlington Heights Road, Suite 620 Arlington Heights, IL 60005-4510 Website: www.iest.org Outside US: Documents available from representative

35、ISO member body organization United States Pharmacopeia (USP) 12601 Twinbrook Parkway Rockville, MD 20852-1790, USA Phone: 800-227-8772 301-881-0666 www.usp.org 3 TERMS AND DEFINITIONS abrasion resistance The ability of a surface of a material to resist abrasion while in use. aliquot A part that is

36、a definite fraction of a whole. barrier glove A glove designed to prevent transmission of materials. basted Sewn with long, loose stitches. bioburden The measure of the number of microorganisms resident on or within products and inanimate objects; also microcount. chemical compatibility The ability

37、of a glove to withstand chemical contact with minimal interaction. IEST-RP-CC005.4 Institute of Environmental Sciences and Technology IEST 2013 All rights reserved 9 chemical degradation A change in properties of materials resulting from contact of the materials with chemicals. Examples: swelling, l

38、oss of tensile strength, deformation, and loss of abrasion resistance. class (airborne particulate cleanliness) The cleanliness classification of air as defined by ISO 14644-1. coincidence In particle counting, an occurrence in which two or more particles pass through the detection beam of the parti

39、cle counter, and the particles are sufficiently close that they are counted as a single particle. colony-forming unit (CFU) The individual or aggregate of many microbial cells, which, when cultivated on solid media, may develop into a single visual colony. denier A unit equal to the mass of a fiber

40、in grams divided by 9,000 m of length. equivalent diameter The diameter of a reference sphere having known properties and producing the same response in the sensing instrument as a particle being measured; see particle size. fiber A solid object usually defined as having a length greater than 100 m

41、and an aspect ratio of at least 10:1. finding An attachment to an item of apparel. Examples: buckles, belts, closures, bindings. flocking A very short or pulverized fiber used to form a velvety layer on the inside of a glove. generated particles Those particles not previously present on the surface

42、of a substrate that are generated and released in response to mechanical energy imparted to that surface. meniscus The curved upper surface of a liquid, resulting from surface tension. particle An object that is solid, liquid, or both, usually between 1 nm and 1 mm in size. particle size The apparen

43、t maximum linear dimension of a particle in the plane of observation as observed with an optical microscope, or the equivalent diameter of a particle detected by automatic instrumentation; see equivalent diameter. permeability The quantitative measure of the ability of a material to transfer mass (s

44、olid, liquid, or gaseous) through its pores, capillaries, or both, under the influence of a pressure gradient. production pack The smallest sealed product unit of measure that would be received by the end user. releasable particles Those particles present on the surface of a substrate that are readi

45、ly releasable from the surface by wetting the substrate with a liquid, but without imparting mechanical energy to the substrate. shelf life The estimated length of time that a product or formulation can be stored before it loses its effectiveness. 10 IEST 2013 All rights reserved Institute of Enviro

46、nmental Sciences and Technology IEST-RP-CC005.4 4 BACKGROUND AND PURPOSE Gloves and finger cots are used in cleanrooms both to ensure the safety of the workers and to preserve the cleanliness of the process and product. This RP provides methods for testing gloves and finger cots in two broad categor

47、ies: physical attributes and cleanliness. Whenever appropriate, suitable methods already existing in the literature are cited; when necessary, new test methods have been developed. 5 PHYSICAL CHARACTERISTICS OF GLOVES AND FINGER COTS Cotton, wool, asbestos, and any other materials likely to release

48、and generate particles should not be used in coverings intended for use in cleanrooms. Powdered gloves or gloves lined with flocking are not recommended. Findings on gloves are discouraged. If findings are used, they should be designed to minimize the generation or entrapment of particles. Conductiv

49、e fibers or fibers made conductive by the addition of conductive materials should be checked to confirm they will not be incompatible with the chemicals expected to be encountered during use. Gloves worn in cleanrooms should be long enough to cover the cuff of the cleanroom garment, overlapping by 2.5 cm (1 in.) or more. Available ASTM standards provide a range for standard sizes for rubber surgical gloves (ASTM D3577), rubber examination gloves (ASTM D3578), and finge