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ASTM E1589-94

(Test Method)

Standard Test Method for Evaluation of First Aid Antiseptic Drug Products (Withdrawn 2003)

Standard Test Method for Evaluation of First Aid Antiseptic Drug Products (Withdrawn 2003)

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 In this test method metric units are used for all applications, except for distance, in which case inches are used and metric units follow in parenthesis.
1.4 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.

General Information

Status
Historical
Publication Date
31-Dec-1993
Withdrawal Date
19-Feb-2003
ICS
11.160 - First aid
Technical Committee
E35 - Pesticides, Antimicrobials, and Alternative Control Agents
Drafting Committee
E35.15 - Antimicrobial Agents
Current Stage
Ref Project

Relations

Replaced By
ASTM E1589-05 - Standard Test Method for Evaluation of First Aid Antiseptic Drug Products
Effective Date
01-Nov-2005

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ASTM E1589-94 - Standard Test Method for Evaluation of First Aid Antiseptic Drug Products (Withdrawn 2003)ASTM E1589-94 - Standard Test Method for Evaluation of First Aid Antiseptic Drug Products (Withdrawn 2003)
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ASTM E1589-94 - Standard Test Method for Evaluation of First Aid Antiseptic Drug Products (Withdrawn 2003)
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:E1589–94
Standard Test Method for
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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope samples plated for total aerobic bacteria count. The counts
obtainedfromthetreatedsitesarecomparedtocountsobtained
1.1 The tests described in this test method are designed to
from untreated occluded sites.
evaluate antimicrobial agents in formulations intended for use
3.1.2 Effect of the Test Agent to Suppress the Growth of
as first aid antiseptic products for their ability to reduce or
Normal Skin Flora When Applied As a Dressing—The dress-
suppress the growth, or both, of the skin microflora.
ings are applied to the forearm for 24 h. The density of the
1.2 A knowledge of microbiological techniques is required
resident organisms that develop under the dressings are com-
for these procedures.
pared to the population that develops on a similar untreated
1.3 In this test method metric units are used for all applica-
occluded site. Following 24 h of occlusion, the sites are
tions, except for distance, in which case inches are used and
microbiologically sampled and the samples plated for total
metric units follow in parenthesis.
aerobic bacteria count.
1.4 This standard does not purport to address all of the
3.2 Theprincipalofthetestisthatthemicrofloraofforearm
safety concerns, if any, associated with its use. It is the
skin is sparse. The impermeable dressing will increase surface
responsibility of the user of this standard to establish appro-
moisture by preventing diffusional water loss and thus expand
priate safety and health practices and determine the applica-
transient resident skin microorganisms. A significant effect by
bility of regulatory limitations prior to use.
thetestagentwillbereflectedbysignificantlylowerpopulation
2. Referenced Documents
on the treated site.
2.1 ASTM Standards:
4. Significance and Use
E1054 Practices for Evaluating Inactivators of Antimicro-
4.1 The procedures in this test method should be used to
bial Agents Used in Disinfectant, Sanitizer, Antiseptic, or
evaluate in vivo the antimicrobial activity of drug products
Preserved Products
applied topically to the skin that are intended to help prevent
3. Summary of Test Methods
infection in minor cuts, scrapes and burns.
4.1.1 This test method is applicable for testing liquids,
3.1 These test methods describe standard in vivo techniques
ointments, powders, films, or dressing containing or impreg-
to determine the following:
nated with an antimicrobial for their effect to reduce an
3.1.1 Effect of the Test Agent to Reduce An Artificially
enhancedskinmicrofloraortheireffectstosuppressthegrowth
Enhanced Skin Microbial Flora—The forearms of subjects are
of the skin flora, or both.
occluded for 48 h prior to application of the test agents to
increase the microbial population on the skin of the volar
5. Apparatus
forearm surface. At treatment the occlusion material is re-
5.1 Colony Counter—Anyofseveraltypesmaybeused,for
moved and the skin is allowed to dry, the test agents are then
example, Quebec colony counter.
appliedtoselectedsites.Atapre-determinedtime(s)following
5.2 Incubator—Any incubator capable of maintaining a
application, the sites are microbiologically sampled and the
temperature of 35 6 2°C may be used.
5.3 Sterilizer—Any suitable steam sterilizer capable of
This test method is under the jurisdiction of ASTM Committee E-35 on
producing the conditions or sterilization.
PesticidesandisthedirectresponsibilityofSubcommitteeE35.15onAntimicrobial
5.4 Timer (Stop-Clock)—Onethatcanbereadforhoursand
Agents.
minutes.
Current edition approved Jan. 15, 1994. Published March 1994.
Annual Book of ASTM Standards, Vol 11.05.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E1589
6. Reagents and Materials 7.1.4 Subject Instructions—Subjects are to refrain from
usinganyproductcontaininganantimicrobialagentforatleast
6.1 Bacteriological Pipette—5.0 and 2.2 mL or 1.1 mL
3 one week prior to the test. Kits containing non-medicated bar
capacity.
soap, shampoo, and roll-on antiperspirant for use during this
6.2 Water Dilution Bottles—Anysterilizableglasscontainer
timeareprovided.Subjectsareinstructednotto usemedicated
having a 150 to 200 mL capacity and tight closure may be
creams, ointments, or take antibiotics. Swimming is not per-
used.
mitted.Subjectsareinstructednottoshowerinthe48hperiod
6.3 Scrubbing Cups—Sterile glass cylinders, height ap-
proceeding the sampling period; however, a sponge bath is
proximately 2.5 cm, inside diameter 2.54 cm.
permitted. These instructions are to be given to each subject
6.4 Rubber Policeman—Can be fashioned in the laboratory
verbally and in written form.
or purchased from most laboratory supply houses.
7.1.5 Test Site Occlusion—Following a two-week wash-out
6.5 Test Formulation—With directions for use.
period, the forearms of each of the twelve volunteers are
6.6 Polyvinyldene-chloride Wrap —Used to occlude skin
occluded with polyvinyldene-chloride wrap patches. The
sites.
polyvinyldene-chloride wrap is cut to fashion a patch that will
6.7 Sampling Solution—Dissolve 0.4 g KH PO , 10.1 g
2 4
coverthevolaraspectoftheforearm,approximately8to10cm
Na HPO and 1.0 g isoctylphenoxypolyethoxyethanol in1L
2 4
by 18 to 20 cm. A patch is placed in the mid-volar surface of
of distilled water. Include in this formulation an activator
each arm and anchored with tape.
specific for the antimicrobial in the test formulation (see
Practices E1054). Adjust to pH 7.8. Dispense in 100 mL
7.1.6 Treatment Procedure—A test product treatment and
volumes and sterilize for 20 min at 121°C. two control sites, no treatment and vehicle control (formula
6.8 Dilution Fluid—Butterfield’s phosphatebufferedwater
without the active), are located on the volar aspect of each
adjusted to pH 7.2, and containing an antimicrobial activator forearm, each site measures 3.5 cm by 3.5 cm.The assignment
specific for the test formulation. (See Practices E1054.)
of the treatment and two controls to the three sites on each
6.9 Plating Medium—Soybean-casein digest agar. forearm is made according to a predetermined randomization
scheme. Approximately 48 h following occlusion, individual
7. Procedure
sitesareexposed10minpriortotreatment,toallowtheareato
7.1 Reduction of Microbial Flora by Products That Are
...

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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.  
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5.1 The emergency medical dispatcher should be a specially trained telecommunicator with specific emergency medical knowledge. Many of these personnel still perform in this role without the benefits of dispatch specific medical training and medically sound protocols. The majority perform their duties without appropriate medical management provided through a structured quality assurance/improvement environment. Training only prepares a new EMD for correct use of the EMDPRS. It cannot ensure that the EMDPRS is used as intended. Since the EMD is clearly defined as a prehospital medical professional, it is necessary to establish sound medical management processes through a multi-component QA/QI program administered by the EMD's agency in conjunction with the physician medical director. Prompt, correct, and appropriate patient care can be enhanced through the use of a standardized approach to quality assurance, especially the component of EMD performance assessment. This practice is intended for use by agencies, organizations, and jurisdictions having the responsibility for providing such services and assurances to the public through the correct management of the nation's emergency medical dispatchers.
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1.1 This practice covers the function of the emergency medical dispatcher (EMD). This function is the prompt and accurate processing of calls for emergency medical assistance. The training and practice through the use of a written or automated medical dispatch protocol is not sufficient in itself to ensure continued medically correct functioning of the EMD. Their dispatch-specific medical training and focal role in EMS has developed to such a complexity that only through a correctly structured and appropriately managed quality assurance environment can the benefits of their practice be fully realized. The philosophies of emergency medical dispatch have established new duties to which the emergency medical dispatch agency must respond. It is important that their quality assurance/quality improvement (QA/QI) activities, including initial hiring, orientation, training and certification, continuing dispatch education, recertification, and performance evaluation be given appropriate managerial attention to help ensure the ongoing safety in the performance of the EMD. This practice establishes functional guidelines for these managerial, administrative, and supervisory functions.  
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SIGNIFICANCE AND USE
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4.2 An AEMT instructor must possess clearly defined knowledge and skills competencies, have clearly defined responsibilities and scope of authority related to instructional programs, and meet other specific requirements pertinent to the level of instruction.  
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SCOPE
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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.  
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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 which include instruction in basic life support knowledge and skills.  
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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 EMT 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 EMT training programs 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 basic life support training courses designed to prepare an individual for certification to practice above the level 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 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.  
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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