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Medical/Surgical Instruments

ASTM is one of the leading standards developers for medical devices. With 24 categories, addressing everything from surgical implements to automated analysis, ASTM medical device standards cover a truly wide range. With how much research and training goes into the medical industry, standardization plays a key role in productively actualizing that effort. Organized below for your convenience by usage, industry, and theme are over 300 standards. This list includes standards related to Medical/Surgical Instruments.

ASTM F1980-21

Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices

1.1 This guide provides information for developing accelerated aging protocols to model the possible effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607"“1: 2019 and the physical properties of their component packaging materials. Guidance for developing accelerated aging protocols may also be used for medical devices and medical device materials. 1.2 Information obtained using this guide may be regarded as sufficient evidence for expiration date claims for medical devices and sterile barrier systems until data from real-time aging studies are available. 1.3 The accelerated aging guideline addresses sterile barrier systems as a whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide. 1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation. Real-time aging (stability) is the requirement of ANSI/AAMI/ISO 11607"“1: 2019. 1.5 Methods used for sterile barrier system performance validation, which include, environmental challenge, distribution, handling, and shipping events, are used for package performance (event-related loss of integrity) testing and are beyond the scope of this guide. 1.6 This guide does not address environmental challenging that simulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F17 for a definition of "environmental challenging." 1.7 The data obtained from accelerated aging studies is not to be used as a manner of establishing label storage conditions for sterile barrier systems. 1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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. 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 E1061-01(2014)

Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers

1.1 This specification covers direct-reading liquid crystal forehead thermometers designed to monitor trends or measure human forehead surface temperatures, or both. 1.2 Thermometers covered by this specification are generally available in continuous or intermittent reading modes. Thermometers meeting the requirements specified herein shall be considered as complying with this specification. 1.3 The following precautionary caveat pertains only to the test method portion, Section 5 , of this specification. 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 consult and establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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ASTM F1026-86(2014)

Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps

1.1 This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and intended for reuse in surgery.

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ASTM F1079-87(2014)

Standard Specification for Inserted and Noninserted Surgical Scissors

1.1 This specification covers general workmanship aspects of inserted and noninserted stainless steel scissors fabricated from stainless steel and intended for reuse in surgery. 1.2 The following safety hazards caveat pertains only to the test method described in this specification: 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.

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ASTM F3014-14

Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures

1.1 This test method describes the procedure for penetration testing sharp and blunt needles used for the placement of surgical sutures. It only describes the test procedures (Phase 1) and does not define a test medium at this time. Test media will be address in the next phase (Phase 2) of this test method s evolution. 1.2 This test method applies to straight and curved surgical needles. 1.3 This test method does not intend to address the value of the test with respect to actual conditions of use. 1.4 In this test method, it is assumed the needles used for this test have passed all applicable quality standards and have no physical malformation that would inappropriately influence the test results. 1.5 This test method quantifies the force required for a needle to pass through a medium and its ability to do so multiple times. 1.6 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. 1.7 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.

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ASTM E1112-00(2018)

Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

1.1 This specification covers electronic instruments intended for intermittent monitoring of patient temperatures. 1.2 This specification does not cover infrared thermometers. Specification E1965 covers specifications for IR thermometers. 1.3 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 non-conformance with the standard. 1.4 The following precautionary caveat pertains only to the test method portion, Section 5 , of this specification. 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 F921-10(2018)

Standard Terminology Relating to Hemostatic Forceps

1.1 This terminology covers basic terms and considerations for the components of hemostatic forceps. Instruments in this terminology are limited to those fabricated from stainless steel and for general surgical procedures. See Fig. 1 and Fig. 2 . FIG. 1 Components of a Hemostatic Forceps FIG. 2 Typical Types of Serrations and Teeth for Hemostatic Forceps 1.2 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 F1078-10(2018)

Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades

1.1 This terminology defines basic terms and considerations for the components of scissors with either inserted or non-inserted blades (see Fig. 1 ). Instruments in this terminology are limited to those fabricated having scissor blades made from stainless steel and used for surgical procedures. FIG. 1 Components of a Scissors (Inserted and Non-Inserted) 1.2 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 F1874-98(2011)

Standard Test Method for Bend Testing of Needles Used in Surgical Sutures

1.1 This test method describes the procedure for bend testing needles used for the placement of surgical sutures. 1.2 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.

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ASTM F2062-00(2018)

Standard Specification for Square Drive Interconnections on Surgical Instruments

1.1 This specification applies to interconnections of surgical instruments used for drilling, tapping, driving, or placing of medical devices during surgery. 1.2 This specification includes dimensions and tolerances for both driving and driven elements. 1.3 The specifications given in ASME B107.4M-1995 are designed for industrial applications and are considered too loose for surgical applications. Springs used for industrial applications are generally made from carbon steel and are capable of higher loads than their stainless steel counterparts. The specifications given in this standard have been written to lessen the chance of accidental disengagement of surgical instruments. This accidental disengagement could injure the patient or end user, or damage or contaminate the instrument. 1.4 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 non-conformance with the standard. 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 E1299-96(2016)

Standard Specification for Reusable Phase-Change-Type Fever Thermometer for Intermittent Determination of Human Temperature

1.1 This specification covers reusable phase-change-type clinical thermometers. 1.2 The following safety hazards caveat pertains only to the test method portion, Section 6 , of this specification. 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.

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ASTM E667-98(2017)

Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers

1.1 This specification covers mercury-in-glass, reusable maximum self-registering clinical thermometers of the types commonly used for measuring body temperatures of humans and of animals. Requirements are given for bulb and stem glasses, mercury, legibility and permanency of markings, dimensions, temperature scale ranges, and graduations, as well as for thermometer stability, ease of resetting, retention of temperature indication, and for accuracy of scale reading. Appropriate methods of testing to determine compliance are provided. Also included is a glossary of terms used in the standard and an appendix with additional information on thermometer glasses and stability. 1.2 All values of temperature in this standard are with reference to the International Temperature Scale of 1990. 1.3 This specification was developed to provide nationally recognized marketing classifications and quality requirements for mercury-in-glass, maximum self-registering clinical thermometers. It is also intended to provide producers, distributors, and users with a common understanding of the characteristics of this product. 1.4 The following precautionary statement pertains only to the test method portion, Section 6 of this specification: 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 E825-98(2016)

Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature

1.1 This specification covers phase change-type clinical thermometers that are designed and intended for one-time use.

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ASTM E1104-98(2016)

Standard Specification for Clinical Thermometer Probe Covers and Sheaths

1.1 This specification covers all single-use clinical thermometer probe covers and sheaths intended for use with any clinical thermometer. Requirements are given for safety, toxicity, handling, labeling, and physical integrity. Testing procedures for appropriate requirements and a glossary of terms used within the standards are provided. 1.2 The requirements contained herein are intended to ensure adequate isolation of the patient from the temperature-measuring device. In addition, the safety and health of the patient shall not be adversely affected. When used in accordance with the manufacturer s instructions, the probe cover, sheath, and temperature measuring device shall remit correct temperature readings as required in Specifications E667 and E1112 .

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ASTM E1965-98(2016)

Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

1.1 This specification covers electronic instruments intended for intermittent measuring and monitoring of patient temperatures by means of detecting the intensity of thermal radiation between the subject of measurement and the sensor. 1.2 The specification addresses assessing subject s body internal temperature through measurement of thermal emission from the ear canal. Performance requirements for noncontact temperature measurement of skin are also provided. 1.3 The specification sets limits for laboratory accuracy and requires determination and disclosure of clinical accuracy of the covered instruments. 1.4 Performance and storage limits under various environmental conditions, requirements for labeling and test procedures are established. Note 1: For electrical safety consult Underwriters Laboratory Standards. 2 Note 2: For electromagnetic emission requirements and tests refer to CISPR 11: 1990 Lists of Methods of Measurement of Electromagnetic Disturbance Characteristics of Industrial, Scientific, and Medical (ISM) Radiofrequency Equipment. 3 1.5 The values of quantities stated in SI units are to be regarded as the standard. The values of quantities in parentheses are not in SI and are optional. 1.6 The following precautionary caveat pertains only to the test method portion, Section 6 , of this specification: 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.

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ASTM F1840-10(2016)

Standard Terminology for Surgical Suture Needles

1.1 This terminology covers general definitions for surgical needles.

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ASTM F1325-91(2016)

Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods

1.1 This specification covers general workmanship aspects of stainless steel suture needle holders intended for reuse in surgery.

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ASTM F1613-95(2016)

Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)

1.1 This specification covers general workmanship aspects of spring-action, tissue, dressing, or pick-up forceps (thumb-type) intended for the retraction, grasping, or dissection of tissue during surgical procedures. 1.2 The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are for information only.

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ASTM F1638-95(2016)e1

Standard Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)

1.1 This terminology defines basic terms and considerations for components of thumb-type surgical forceps. Instruments with this terminology are limited to those fabricated from stainless steel and used for surgical procedures.

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ASTM F1744-96(2016)

Standard Guide for Care and Handling of Stainless Steel Surgical Instruments

1.1 This guide is intended to provide a better understanding of the care of stainless steel surgical instruments intended for reuse. This guide is not intended for use with electrical, pneumatic or other powered surgical instruments.

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ASTM F2132-01(2008)e1

Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps

1.1 The purpose of this specification is to provide a test procedure and performance requirement for the puncture resistance of materials used in the construction of containers for discarded medical needles and other sharps. This test specification will establish ( 1 ) the average puncture force and ( 2 ) a minimum value of puncture force that container material(s) must withstand when following the test procedure described in Section 6. This specification shall be applicable to regions of uniform material and thickness, and needle contact areas as defined in 3.1.7 and 3.1.9. Materials meeting the performance requirements of Section 4 shall be considered puncture-resistant. This specification does not evaluate the construction of, or provide pass/fail criteria for, a sharps container. 1.2 This specification provides a test procedure to determine if all regions of one container meet the material puncture resistance requirements. It does not define the number of additional test containers required to achieve a statistically valid sample of a manufacturing lot or process. An appropriate sampling plan shall be determined by the test requester, as this depends upon the manufacturing process variability, manufacturing lot size, and other factors, such as end-user requirements. 1.3 This specification is intended to evaluate the performance of materials used in the construction or manufacture of sharps containers under controlled laboratory conditions, and at normal room temperature (see 6.1). ( Warning This specification only characterizes material puncture resistance at normal room temperatures. Applications of sharps containers outside the range of 23 2 C (such as usage in emergency vehicles) require further material characterization by the product specifier to determine suitable use.) 1.4 The values stated in inch/pound are to be regarded as the standard. The SI values given in parentheses are for information only. 1.5 The following hazard caveat pertains only to the test procedure portion, Section 6, of this specification. 1.6 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.

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