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ASTM E1173-23

(Practice)

Standard Practice for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations

Standard Practice for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations

SIGNIFICANCE AND USE
5.1 These procedures should be used to test topical antimicrobial-containing preparations that are intended to be fast-acting in reducing significantly the number of microorganisms on intact skin immediately and, for preoperative and vascular precatheterization preparations, maintenance of some degree of reduction for an extended time.
SCOPE
1.1 The practice is designed to measure the reduction of the microflora of the skin.  
1.2 A knowledge of microbiological techniques is required for these procedures.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3.1 Exception—In this practice, metric units are used for all applications except for linear measure, in which case inches are used, and metric units follow in parentheses.  
1.4 Performance of this procedure requires a knowledge of regulations pertaining to the protection of human subjects (1).2
Note 1: Importantly, it must be noted that the FDA currently does not accept data resulting from procedures in this Method for testing products for approval as Vascular Precatheterization Skin Preparations.  
1.5 This standard does not purport to address all of the safety problems, 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
31-Mar-2023
ICS
11.080.01 - Sterilization and disinfection in general
Technical Committee
E35 - Pesticides, Antimicrobials, and Alternative Control Agents
Drafting Committee
E35.15 - Antimicrobial Agents
Current Stage
Ref Project

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ASTM E1173-23 - Standard Practice for Evaluation of Preoperative, Precatheterization, or Preinjection Skin PreparationsASTM E1173-23 - Standard Practice for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations
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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: E1173 − 23
Standard Practice for
Evaluation of Preoperative, Precatheterization, or
1
Preinjection Skin Preparations
This standard is issued under the fixed designation E1173; 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 E1054 Practices for Evaluation of Inactivators of Antimicro-
bial Agents
1.1 The practice is designed to measure the reduction of the
E1874 Practice for Recovery of Microorganisms From Skin
microflora of the skin.
using the Cup Scrub Technique
1.2 A knowledge of microbiological techniques is required
E2756 Terminology Relating to Antimicrobial and Antiviral
for these procedures.
Agents
1.3 The values stated in SI units are to be regarded as
3. Terminology
standard. No other units of measurement are included in this
standard.
3.1 Terms used in this standard are defined in E2756,
1.3.1 Exception—In this practice, metric units are used for Standard Terminology Relating to Antimicrobial and Antiviral
all applications except for linear measure, in which case inches
Agents. Others defined below are specific to their use in this
are used, and metric units follow in parentheses. document.
1.4 Performance of this procedure requires a knowledge of
3.2 Definitions of Terms Specific to This Standard:
2
regulations pertaining to the protection of human subjects (1). 3.2.1 active ingredient, n—a substance added to a formula-
NOTE 1—Importantly, it must be noted that the FDA currently does not
tion specifically for the inhibition or inactivation of microor-
accept data resulting from procedures in this Method for testing products
ganisms.
for approval as Vascular Precatheterization Skin Preparations.
3.2.2 inguen, n—groin: the junctional region between the
1.5 This standard does not purport to address all of the
abdomen and thigh; pl. inguina.
safety problems, if any, associated with its use. It is the
3.2.3 inguinal crease, n—the discrete region of flexure
responsibility of the user of this standard to establish appro-
between the abdomen and the thigh.
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
3.2.4 sampling fluid, n—a recovery fluid that contains a
1.6 This international standard was developed in accor-
neutralizer demonstrated to inactivate or quench the active
dance with internationally recognized principles on standard-
ingredient(s) in the test formulation and the positive and
ization established in the Decision on Principles for the
negative control formulations. See Practices E1054.
Development of International Standards, Guides and Recom-
3.2.5 test formulation, n—a formulation containing an ac-
mendations issued by the World Trade Organization Technical
tive ingredient(s).
Barriers to Trade (TBT) Committee.
4. Summary of Test Method
2. Referenced Documents
4.1 This practice is conducted on human subjects selected
3
2.1 ASTM Standards:
randomly from a group of volunteers who, after refraining
voluntarily from using topical and oral antimicrobials for at
least two weeks (14 days), exhibit acceptably high normal flora
1
This practice is under the jurisdiction of ASTM Committee E35 on Pesticides,
counts on the skin sites to be used in testing (see Section 8).
Antimicrobials, and Alternative Control Agents and is the direct responsibility of
Subcommittee E35.15 on Antimicrobial Agents.
4.2 The antimicrobial activity of preoperative, vascular
Current edition approved April 1, 2023. Published May 2023. Originally
precatheterization, or preinjection skin preparations and of
approved in 1987. Last previous edition approved in 2015 as E1173 – 15. DOI:
controls is measured by comparing microbial counts, obtained
10.1520/E1173-23.
2
at various time intervals after application of a formulation to
The boldface numbers in parentheses refer to the list of references at the end of
this standard.
skin sites to counts obtained from those same sites prior to
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
application of a formulation. Skin sites recommended for use
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
in testing are: (1) the inguinal region and the abdomen for
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. preoperative skin preparations; (2) the inguinal region, the
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Consho
...

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: E1173 − 15 E1173 − 23
Standard Test Method Practice for
Evaluation of Preoperative, Precatheterization, or
1
Preinjection Skin Preparations
This standard is issued under the fixed designation E1173; 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 test method practice is designed to measure the reduction of the microflora of the skin.
1.2 A knowledge of microbiological techniques is required for these procedures.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3.1 Exception—In this test method, practice, metric units are used for all applications except for linear measure, in which case
inches are used, and metric units follow in parentheses.
2
1.4 Performance of this procedure requires a knowledge of regulations pertaining to the protection of human subjects (1).
NOTE 1—Importantly, it must be noted that the FDA currently does not accept data resulting from procedures in this Method for testing products for
approval as Vascular Precatheterization Skin Preparations.
1.5 This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and healthsafety, 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.
2. Referenced Documents
3
2.1 ASTM Standards:
E1054 Practices for Evaluation of Inactivators of Antimicrobial Agents
E1874 Practice for Recovery of Microorganisms From Skin using the Cup Scrub Technique
E2756 Terminology Relating to Antimicrobial and Antiviral Agents
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 May 1, 2015April 1, 2023. Published July 2015May 2023. Originally approved in 1987. Last previous edition approved in 20092015 as
E1173 – 01E1173 – 15.(2009). DOI: 10.1520/E1173-15.10.1520/E1173-23.
2
The boldface numbers in parentheses refer to the list of references at the end of this standard.
3
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1173 − 23
3. Terminology
3.1 Terms used in this standard are defined in E2756, Standard Terminology Relating to Antimicrobial and Antiviral Agents.
Others defined below are specific to their use in this document.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 active ingredient, n—a substance added to a formulation specifically for the inhibition or inactivation of microorganisms.
3.2.2 inguen, n—groin: the junctional region between the abdomen and thigh; pl. inguina.
3.2.3 inguinal crease—crease, n—the discrete region of flexure between the abdomen and the thigh.
3.2.4 sampling fluid—fluid, n—a recovery fluid that contains a neutralizer demonstrated to inactivate or quench the active
ingredient(s) in the test and reference formulation and the positive and negative control formulations. See Test Method Practices
E1054.
3.2.5 test formulation—formulation, n—a formulation containing an active ingredient(s).
4. Summary of Test Method
4.1 These test methods are This practice is conducted on human subjects selected randomly from a group of volunteers who, after
refraining voluntarily from using topical and oral antimicrobials for at least two weeks (14 days), exhibit acceptably high normal
flora counts on the skin sites to be used in testing (see Section 8).
4.2 The antimicrobial activity of preoperative, vascular precathet
...

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SCOPE
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1.3 The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are for information only.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 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 F2886-17(2023)(Specification)
Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications

ABSTRACT
This specification covers chemical, mechanical, and metallurgical general requirements for metal injection molded (MIM) cobalt-28chromium-6molybddenum components to be used in manufacturing surgical implants. In this specification, the MIM components covered may have been densified beyond their as-sintered density by post-sinter processing. For the chemical requirements, the components supplied in this specification must conform in accordance to the chemical requirements specified herein in Table 1. The product analysis tolerances must also conform to the product tolerances presented in Table 2. The specification also enumerates the mechanical requirements for MIM components wherein the tensile properties of the MIM must conform to the mechanical properties in Table 3. The microstructural requirements and specimen preparation shall be in accordance with Guide E3 and Practice E407.
SCOPE
1.1 This specification covers chemical, mechanical, and metallurgical requirements for metal injection molded (MIM) cobalt-28chromium-6molybdenum components to be used in the manufacture of surgical implants  
1.2 The MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinter processing.  
1.3 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
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 A480/A480M-23a(Specification)
Standard Specification for General Requirements for Flat-Rolled Stainless and Heat-Resisting Steel Plate, Sheet, and Strip

ABSTRACT
This specification covers general requirements for flat-rolled stainless and heat-resisting steel plate, sheet, and strip. The steel shall be made by one of the following processes: electric-arc, electric-induction, or other suitable processes. Heat and product analyses shall conform to the chemical requirements for each of the specific elements. The material shall undergo mechanical tests such as tension test, hardness test, and bend test. Special tests like intergranular corrosion test, permeability test, Charpy impact testing and tests for detrimental intermetallic phases in wrought duplex stainless steels shall be also be performed when required.
SCOPE
1.1 This specification2 covers a group of general requirements that, unless otherwise specified in the purchase order or in an individual specification, shall apply to rolled steel plate, sheet, and strip, under each of the following specifications issued by ASTM: Specifications A240/A240M, A263, A264, A265, A666, A693, A793, and A895.  
1.2 In the case of conflict between a requirement of a product specification and a requirement of this specification, the product specification shall prevail. In the case of conflict between a requirement of the product specification or a requirement of this specification and a more stringent requirement of the purchase order, the purchase order shall prevail. The purchase order requirements shall not take precedence if they, in any way, violate the requirements of the product specification or this specification; for example, by waiving a test requirement or by making a test requirement less stringent.  
1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The SI units are shown in brackets, except that when A480M is specified, Annex A3 shall apply for the dimensional tolerances and not the bracketed SI values in Annex A2. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
1.4 This specification and the applicable material specifications are expressed in both inch-pound and SI units. However, unless the order specifies the applicable “M” specification designation [SI units], the material shall be furnished in inch-pound units.  
1.5 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 E2552-23(Guide)
Standard Guide for Assessing the Environmental and Human Health Impacts of New Compounds for Military Use

SIGNIFICANCE AND USE
5.1 The purpose of this guide is to provide a logical, tiered approach in the development of environmental health criteria coincident with level and effort in the research, development, testing, and evaluation of new materials for military use. Various levels of uncertainty are associated with data collected from previous stages. Following the recommendation in the guide should reduce the relative uncertainty of the data collected at each developmental stage. At each stage, a general weight of evidence qualifier shall accompany each exposure/effect relationship. They may be simple (for example, low, medium, or high confidence) or sophisticated using a numerical value for each predictor as a multiplier to ascertain relative confidence in each step of risk characterization. The specific method used will depend on the stage of development, quantity and availability of data, variation in the measurement, and general knowledge of the dataset. Since specific formulations, conditions, and use scenarios may not be known until the later stages, exposure estimates can be determined when practical (for example, Engineering and Manufacturing Development; see 6.6). Exposure data can then be used with other toxicological data collected from previous stages in a quantitative risk assessment to determine the relative degree of hazard.  
5.2 Data developed from the use of this guide are designed to be consistent with criteria required in weapons and weapons system development (for example, programmatic environment, safety and occupational health evaluations, environmental assessments/environmental impact statements, toxicity clearances, and technical data sheets).  
5.3 Information shall be evaluated in a flexible manner consistent with the needs of the authorizing program. This requires proper characterization of the current problem. For example, compounds may be ranked relative to the environmental criteria of the prospective alternatives, the replacement compound, and within bo...
SCOPE
1.1 This guide is intended to determine the relative environmental influence of new substances, consistent with the research and development (R&D) level of effort and is intended to be applied in a logical, tiered manner that parallels both the available funding and the stage of research, development, testing, and evaluation. Specifically, conservative assumptions, relationships, and models are recommended early in the research stage, and as the technology is matured, empirical data will be developed and used. Munition constituents are included and may include propellants, oxidizers, explosives, binders, stabilizers, metals, dyes, and other compounds used in the formulation to produce a desired effect. Munition systems range from projectiles, grenades, rockets/missiles, training simulators, to smokes and obscurants. Given the complexity of issues involved in the assessment of environmental fate and effects and the diversity of the systems used, this guide is broad in scope and not intended to address every factor that may be important in an environmental context. Rather, it is intended to reduce uncertainty at minimal cost by considering the most important factors related to human health and environmental impacts of energetic materials. This guide provides an outline for collecting data useful in a relative ranking procedure to provide the systems scientist with a sound basis for prospectively determining a selection of candidates based on environmental and human health criteria. The general principles in this guide are applicable to substances other than energetics if intended to be used in a similar manner with similar exposure profiles.  
1.2 The scope of this guide includes:  
1.2.1 Energetic and other new/novel materials and compositions in all stages of research, development, test and evaluation.  
1.2.2 Environmental assessment, including:
1.2.2.1 Human and ecological effects of the unexploded energetics and ...

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