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ASTM E1589-21

(Practice)

Standard Practice for Evaluation of First Aid Antiseptic Drug Products

Standard Practice for Evaluation of First Aid Antiseptic Drug Products

SIGNIFICANCE AND USE
5.1 The procedures in this practice should be used for in vivo evaluation of the antimicrobial activity of drug products applied topically to the skin that are intended to help prevent infection in minor cuts, scrapes and burns.  
5.1.1 This practice is applicable for testing liquids, ointments, powders, films, or dressings, containing or impregnated with an antimicrobial agent, for their effect to reduce an enhanced skin microflora or their effects to suppress the growth of the skin flora, or both.
SCOPE
1.1 The tests described in this practice are designed to evaluate antimicrobial agents in formulations intended for use as first aid antiseptic products for their ability to reduce or suppress the growth, or both, of the skin microflora.  
1.2 A knowledge of microbiological techniques is required for these procedures.  
1.3 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects. (See CFR Parts 50 and 56.)  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

Status
Published
Publication Date
30-Sep-2021
ICS
11.160 - First aid
Technical Committee
E35 - Pesticides, Antimicrobials, and Alternative Control Agents
Drafting Committee
E35.15 - Antimicrobial Agents
Current Stage
Ref Project

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Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E1589 − 21
Standard Practice for
1
Evaluation of First Aid Antiseptic Drug Products
This standard is issued under the fixed designation E1589; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope E2756 Terminology Relating to Antimicrobial and Antiviral
Agents
1.1 The tests described in this practice are designed to
3
2.2 Federal Standards:
evaluate antimicrobial agents in formulations intended for use
CFR Parts 50 and 56 Code of Federal Regulations: Protec-
as first aid antiseptic products for their ability to reduce or
tion of Human Subjects; Institutional Review Boards
suppress the growth, or both, of the skin microflora.
1.2 A knowledge of microbiological techniques is required
3. Terminology
for these procedures.
3.1 For definitions of terms used in this practice, refer to
1.3 Performance of this procedure requires the knowledge
E2756 Terminology Relating to Antimicrobial and Antiviral
of regulations pertaining to the protection of human subjects.
Agents.
(See CFR Parts 50 and 56.)
3.2 Definitions of Terms Specific to This Standard:
1.4 The values stated in SI units are to be regarded as
3.2.1 active ingredient, n—a substance performing a func-
standard. No other units of measurement are included in this
tion defined by this method.
standard.
3.2.2 neutralizer, n—a procedure or chemical agent used to
1.5 This standard does not purport to address all of the
inactivate,neutralize,orquenchthemicrobiocidalpropertiesof
safety concerns, if any, associated with its use. It is the
an antimicrobial agent.
responsibility of the user of this standard to establish appro-
3.2.3 sampling fluid, n—a recovery fluid that may or may
priate safety, health, and environmental practices and deter-
not contain a neutralizer to inactivate the active ingredients in
mine the applicability of regulatory limitations prior to use.
test and internal reference formulations.
1.6 This international standard was developed in accor-
3.2.4 test formulation, n—a formulation containing an ac-
dance with internationally recognized principles on standard-
tive ingredient(s).
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
4. Summary of Practice
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee. 4.1 These test procedures describe standard in vivo tech-
niques to determine the following:
2. Referenced Documents 4.1.1 Effect of the Test Formulation to Reduce anArtificially
2
Enhanced Skin Microbial Flora—The forearms of subjects are
2.1 ASTM Standards:
occluded for 48 h prior to application of the test formulation to
D1193 Specification for Reagent Water
increase the microbial population on the skin of the volar
E1054 Practices for Evaluation of Inactivators ofAntimicro-
forearm surface. At treatment the occlusion material is re-
bial Agents
moved and the skin is allowed to dry, the test formulation is
E1874 Test Method for Recovery of Microorganisms From
then applied to selected sites. At a pre-determined time(s)
Skin using the Cup Scrub Technique
following application, the sites are microbiologically sampled
and the samples are plated for total aerobic bacteria count. The
counts obtained from the treated sites are compared to counts
1
This practice is under the jurisdiction ofASTM Committee E35 on Pesticides,
obtained from untreated occluded sites.
Antimicrobials, and Alternative Control Agents and is the direct responsibility of
4.1.2 Effect of the Test Formulation to Suppress the Growth
Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved Oct. 1, 2021. Published January 2022. Originally
of Normal Skin Flora When Applied As a Dressing—The
approved in 1994. Last previous edition approved in 2015 as E1589 – 05(2015).
dressingsareappliedtotheforearmfor24h.Thedensityofthe
DOI: 10.1520/E1589-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on Available from U.S. Government Publishing Office, 732 N. Capitol St., NW,
the ASTM website. Washington DC, 20401-0001, http://www.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1589 − 21
4
residen
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E1589 − 05 (Reapproved 2015) E1589 − 21
Standard Test Method Practice for
1
Evaluation of First Aid Antiseptic Drug Products
This standard is issued under the fixed designation E1589; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 The tests described in this test method are designed to evaluate antimicrobial agents in formulations intended for use as first
aid antiseptic products for their ability to reduce or suppress the growth, or both, of the skin microflora.
1.2 A knowledge of microbiological techniques is required for these procedures.
1.3 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects. (See CFR
Parts 50 and 56.)
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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
2
2.1 ASTM Standards:
D1193 Specification for Reagent Water
E1054 Practices for Evaluation of Inactivators of Antimicrobial Agents
3
2.2 Federal Standards:
CFR Parts 50 and 56
3. Terminology
3.1 active ingredient, n—a substance performing a function defined by this method.
3.2 neutralization, n—a process which results in quenching or inactivating inactivation of the antimicrobial activity of a
formulation. This may be achieved with dilution of the formulation, or with the use of chemical agents, called neutralizers.
3.3 neutralizer, n—a procedure or chemical agent used to inactivate, neutralize, or quench the microbiocidal properties of an
antimicrobial agent.
1
This test method practice is under the jurisdiction of ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents and is the direct responsibility
of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved Oct. 1, 2015Oct. 1, 2021. Published November 2015January 2022. Originally approved in 1994. Last previous edition approved in 20102015
as E1589 – 05(2010).(2015). DOI: 10.1520/E1589-05R15.10.1520/E1589-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from U.S. Government Publishing Office, 732 N. Capitol St., NW, Washington DC, 20401-0001, http://www.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1589 − 21
3.4 resident microorganisms, n—microorganisms that live and multiply on skin, forming a permanent population.
3.5 sampling fluid, n—a recovery fluid that may or may not contain a neutralizer to inactivate the active ingredients in test and
internal reference formulations.
3.6 test formulation, n—a formulation containing an active ingredient(s).
3.7 transient microorganisms, n—microorganisms that contaminate but do not normally permanently colonize the skin.
4. Summary of Test Method
4.1 These test methods describe standard in vivo techniques to determine the following:
4.1.1 Effect of the Test Formulation to Reduce an Artificially Enhanced Skin Microbial Flora—The forearms of subjects are
occluded for 48 h prior to application of the test formulation to increase the microbial population on the skin of the volar forearm
surface. At treatment the occlusion material is removed and the skin is allowed to dry, the test formulation is then applied to
selected sites. At a pre-determined time(s) following application, the sites are microbiologically sampled and the samples plated
for total aerobic bacteria count. The counts obtained from the treated sites are compared to counts obtained from untreated
occluded sites.
4.1.2 Effect of the Test Formulation to Suppress the Growth of Normal Skin Flora When Applied As a Dressing—The dressings
are applied to the forearm for 24 h. The density of the resident microorganisms that develop under the dressings are compared
...

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1.8 This guide does not establish certification requirements. Such requirements should be established by the certifying agency in the jurisdiction in which the EMT instructor will function. This guide may be used to provide considerable guidance to the jurisdiction responsible for establishing certification standards.  
1.9 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
Note 1: Also see Practice F1031.  
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SIGNIFICANCE AND USE
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SCOPE
1.1 This guide is intended to assist emergency medical services (EMS) agencies and institutions in selecting and utilizing individuals who teach in EMT (emergency medical technician) training programs that include instruction in advanced life support knowledge and skills.  
1.2 This guide identifies six categories of instructor in an AEMT (advanced emergency medical technician) training program: adjunct instructor, clinical/field preceptor, practical skills instructor, associate instructor, course instructor/coordinator (I/C), and course administrator. The guide recognizes that an individual may, depending on his/her level of practice and the training program involved, function in any or all of these categories.  
1.3 This guide includes specific guidelines for qualifications, training, education, experience, scope of authority, responsibilities, continuing education, evaluation, and maintenance of competency when applicable.  
1.4 This guide does not include specific guidelines for the course administrator or the adjunct instructor. While the guide recognizes, by offering a definition of each category, that these types of individuals function in many AEMT training programs, the limited instructional roles played by these individuals preclude the need for specific selection and utilization guidelines.  
1.5 This guide is intended to apply to any individual who teaches in an AEMT training program regardless of the individual's present level of clinical practice.  
1.6 This guide intentionally omits references to length of pre-hospital care experience, teaching experience, and continuing education requirements. This guide also omits reference to waiver or equivalency. These issues should be addressed by the appropriate agency.  
1.7 This guide applies only to instructors who teach in AEMT training courses designed to prepare an individual for certification to practice above the level of the EMT. It does not apply to instructors who teach in specialized courses that do not in themselves qualify the individual for a level of EMT certification.  
1.8 This guide does not establish certification requirements. Such requirements should be established by the certifying agency in the jurisdiction in which the AEMT instructor will function. This guide may be used to provide considerable guidance to the jurisdiction responsible for establishing certification standards.  
1.9 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
Note 1: Also see Practice F1031.  
1.10 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM F1285-22(Guide)
Standard Guide for Training the Emergency Medical Technician to Perform Patient Examination Techniques

SIGNIFICANCE AND USE
4.1 This guide establishes the minimum national standard for training the Emergency Medical Technician to perform patient examination techniques on patients of all ages.  
4.2 This guide shall be used by those who wish to identify the minimum training standard for the Emergency Medical Technician as it relates to the performance of patient examination techniques.  
4.3 This guide shall be used as the basis to revise Practice F1031.  
4.4 Every person who is identified as an Emergency Medical Technician shall have been trained in accordance with this guide.  
4.5 This guide does not stand alone and must be used in conjunction with the applicable documents cited in Section 2.
SCOPE
1.1 This guide covers the minimum patient examination techniques that the Emergency Medical Technician shall be trained to use when assessing ill or injured patients of all ages.  
1.2 This guide is one of a series which together describe the minimum training standard for the Emergency Medical Technician.  
1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM F1149-22(Practice)
Standard Practice for Qualifications, Responsibilities, and Authority of Individuals and Institutions Providing Medical Direction of Emergency Medical Services

SIGNIFICANCE AND USE
4.1 Implementation of this practice will ensure that the EMS system has the authority commensurate with the responsibility to ensure adequate medical direction of all pre-hospital providers, as well as personnel and facilities that meet minimum criteria to implement medical direction of pre-hospital services.  
4.1.1 The state will develop, recommend, and encourage use of a plan that would ensure the standards outlined in this document can be implemented as appropriate at the local, regional, or state level (see Guide F1086).  
4.1.2 This practice is intended to describe and define responsibility for medical directions during transfers. It is not intended to determine the medical or legal, or both, appropriateness of transfers under the Consolidated Omnibus Budget Reconciliation Act and other similar federal or state laws, or both.
SCOPE
1.1 This practice covers the qualifications, responsibilities, and authority of individuals and institutions providing medical direction of emergency medical services.  
1.2 This practice addresses the qualifications, authority, and responsibility of a Medical Director (off-line) and the relationship of the EMS (Emergency Medical Services) provider to this individual.  
1.3 This practice also addresses components of on-line medical direction (direct medical control) including the qualifications and responsibilities of on-line medical physicians and the relationship of the pre-hospital provider to on-line medical direction.  
1.4 This practice addresses the relationship of the on-line medical physician to the off-line Medical Director.  
1.5 The authority for control of medical services at the scene of a medical emergency is addressed in this practice.  
1.6 The requirements for a Communication Resource are also addressed within this practice.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM F1127-22(Guide)
Standard Guide for Containment of Hazardous Material Spills by Emergency Response Personnel

SIGNIFICANCE AND USE
4.1 This guide contains information regarding the containment of a hazardous material that has escaped from its container. If a material can be contained, the impact on the environment and the threat it poses to responders and the general public is usually reduced. The techniques described in this guide are among those that may be used by emergency responders to lessen the impact of a discharge. Initial hazard assessment should be performed before applying mitigation techniques.  
4.2 Emergency responders might include police, fire service personnel, government spill response personnel, industrial response personnel, or spill response contractors. In order to apply any of the techniques described in this guide, appropriate training is recommended. See OSHA Hazardous Waste and Emergency Response Standard (HAZWOPER) requirements.
SCOPE
1.1 This guide describes methods to contain the spread of hazardous materials that have been discharged into the environment. It is directed toward those emergency response personnel who have had adequate hazardous material response training.  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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  • Guide
    6 pages
    English language
    sale 15% off