F04.33 - Medical/Surgical Instruments

SCOPE
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.3 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.

ABSTRACT
This specification covers general workmanship requirements of spring-action, surgical tissue, dressing, or pick-up forceps (thumb type) for use in the retraction, grasping, or dissection of tissue during surgical procedures. However, this specification does not cover delicate tissue forceps such as employed in microsurgery or neurosurgery. The forceps and all component parts shall be manufactured from Class 4 martensitic stainless steel (heat treated), while modified working ends may be manufactured from stellite, tungsten carbide, or other suitable material. The forcep halves shall be symmetrical, with the teeth well formed, uniform in depth and spacing, and mesh without binding, and the surfaces uniformly finished and free of burrs, sharp edges, cracks, coarse marks, and processing materials. In addition, the forceps shall have handle serrations that are uniform in depth and spacing. Tests for hardness and corrosion resistance shall be performed and shall conform to the requirements specified.
SCOPE
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.  
1.3 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.

ABSTRACT
This specification covers general workmanship and test method requirements of stainless steel suture needle holders intended for reuse in surgery. Materials of all component parts shall be fabricated from martensitic stainless steel type 410, 410X, 416, 420A, 420B, 420C, 420F, 420F Mod, and 440B. The material shall be heat treated and shall conform to the specified hardness, corrosion resistance, workmanship, finish, and appearance.
SCOPE
1.1 This specification covers general workmanship aspects of stainless steel suture needle holders intended for reuse in surgery.  
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.

ABSTRACT
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 are provided. Toxicity test, leakage test, and compatibility test shall be performed to meet the requirements prescribed.
SCOPE
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.  
1.3 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.

ABSTRACT
This specification covers the test methods and corresponding requirements for phase change-type disposable (for one time use only) clinical thermometers used for the intermittent determination of human temperature. When examined using the test methods suggested herein, sampled specimens shall comply with the specified requirements as to temperature range and graduation, accuracy, measurement retention, operating environment, storage environment, toxicity, workmanship, stability, and marking and labeling.
SCOPE
1.1 This specification covers phase change-type clinical thermometers that are designed and intended for one-time use.  
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.

ABSTRACT
This terminology covers the general definitions of terms specific to stainless steel surgical suture needles.
SCOPE
1.1 This terminology covers general definitions for surgical needles.  
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.

SCOPE
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.  
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.

ABSTRACT
This specification covers infrared thermometers, which are electronic instruments intended for the intermittent measurement and monitoring of patient temperatures by means of detecting the intensity of thermal radiation between the subject of measurement and the sensor. The specification addresses the assessment of the subject's internal body temperature through measurement of thermal emission from the ear canal. Though, performance requirements for noncontact temperature measurement of skin are also provided. Limits are set for laboratory accuracy, and determination and disclosure of clinical accuracy of the covered instruments are required. Performance and storage limits under various environmental conditions, requirements for labeling, and test procedures are all established herein.
SCOPE
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
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.

SIGNIFICANCE AND USE
5.1 This test method determines whether Huber needles are designed and manufactured such that they will not produce a core during simulated implantable port access.  
5.2 If a needle produces a core during actual use, leaking of the implantable port may occur. Also, the core may be flushed into the port’s reservoir and subsequently into the patient’s body.
SCOPE
1.1 This test method covers the qualitative measurement of Huber-type needles’ potential to remove septum material during implantable port access (1).2  
1.2 This test method does not address other issues that may include, but are not limited to, force measurement during the perforation/withdrawal, septum integrity, and any safety issues.  
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.

ABSTRACT
This specification covers the requirements and test methods for direct-reading liquid crystal forehead thermometers, in either the continuous or intermittent reading modes, designed to monitor trends or measure human forehead surface temperatures, or both. When examined by test methods recommended herein, each thermometer shall comply with thermal profile, temperature range, tolerance, sequencing, operating and storage environment, and labeling requirements.
SCOPE
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 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.

ABSTRACT
This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and intended for reuse in surgery. All of the component parts of the instruments shall be made of martensitic stainless steel of Type 410, 410X, 416, 416MOD, 420A, or 420B. Materials shall be tested and the individual grades shall conform to physical requirements such as heat treatment, hardness, and passivation; performance requirements such as finger rings, jaw serrations and teeth, box lock, clearance, ratchets, jaw and rachet setting, elasticity, and corrosion resistance. Workmanship, finish, and appearance, are also detailed.
SCOPE
1.1 This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and intended for reuse in surgery.  
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.

ABSTRACT
This specification covers the general workmanship aspects of inserted and noninserted 410, 410K, 416, 420, 420A, and 420B martensitic stainless steel scissors intended for reuse in surgery. Inserts should be made of stellite, tungsten carbide, or other suitable materials. The instruments should conform to the required values of corrosion resistance cutting ability, Rockwell hardness, and physical properties after passivation and heat treatment. The products should also have finger rings, joints, cutting edges, pivot screws, and finish that are of the required quality.
SCOPE
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.3 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.

ABSTRACT
This specification covers the dimensions and tolerances for both driving and driven elements in square drive interconnections on stainless steel surgical instruments used for drilling, tapping, driving, or placing of medical devices during surgery. The specification is intended to lessen the chance of accidental disengagement of surgical instruments.
SCOPE
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.

SCOPE
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.

ABSTRACT
This specification covers electronic instruments intended for intermittent monitoring of patient temperatures. The temperature range of the instrument shall display temperature within the specific range requirement and regards to its accuracy, no individual reading shall be in error by more than the values that are determined. The operating environment must meet the determined accuracy requirements when operated in an environment of a certain temperature and also with a certain relative humidity. The resolutions of analog display such as Celsius graduations, Fahrenheit graduations, scale graduation marks and pointer width shall also be observed. Its digital display shall conform to the standard resolution, readability and buttery condition of the material. The case material of the instrument and non disposable accessories shall withstand biological and physical cleaning without performance degradation. It shall also withstand dropping without presenting an electrical safety hazard. Those parts of the electronic thermometer system intended for contact with anatomical sites for the purpose of temperature measurement as specified by the manufacturer shall be also be nontoxic. The following tests shall be conducted in order to determine the instrument's performance: cleaning test, toxicity test, and accuracy test.
SCOPE
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.

SCOPE
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.

ABSTRACT
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. The stainless steels most used are martensitic and austenitic types. The instruments shall be used only for their intended purpose, such as cutting, holding, clamping, retracting, and so forth. Undue stress or strain should be avoided when handling and cleaning. The guide includes care in particular for hemostatic forceps, needle holders, scissors, microsurgical instruments, instrument kits, and other sharp instruments. The instrument care specified includes cleaning, lubrication, and inspection. Testing, repair and restoration, and sterilization are specified.
SCOPE
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.

SCOPE
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.

SIGNIFICANCE AND USE
5.1 This test method determines whether Huber needles are designed and manufactured such that they will not produce a core during simulated implantable port access.  
5.2 If a needle produces a core during actual use, leaking of the implantable port may occur. Also, the core may be flushed into the port’s reservoir and subsequently into the patient’s body.
SCOPE
1.1 This test method covers the qualitative measurement of Huber-type needles’ potential to remove septum material during implantable port access (1)2.  
1.2 This test method does not address other issues that may include, but are not limited to, force measurement during the perforation/withdrawal, septum integrity, and any safety issues.  
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 and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This specification covers infrared thermometers, which are electronic instruments intended for the intermittent measurement and monitoring of patient temperatures by means of detecting the intensity of thermal radiation between the subject of measurement and the sensor. The specification addresses the assessment of the subject's internal body temperature through measurement of thermal emission from the ear canal. Though, performance requirements for noncontact temperature measurement of skin are also provided. Limits are set for laboratory accuracy, and determination and disclosure of clinical accuracy of the covered instruments are required. Performance and storage limits under various environmental conditions, requirements for labeling, and test procedures are all established herein.
SCOPE
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.

ABSTRACT
This specification covers general workmanship requirements of spring-action, surgical tissue, dressing, or pick-up forceps (thumb type) for use in the retraction, grasping, or dissection of tissue during surgical procedures. However, this specification does not cover delicate tissue forceps such as employed in microsurgery or neurosurgery. The forceps and all component parts shall be manufactured from Class 4 martensitic stainless steel (heat treated), while modified working ends may be manufactured from stellite, tungsten carbide, or other suitable material. The forcep halves shall be symmetrical, with the teeth well formed, uniform in depth and spacing, and mesh without binding, and the surfaces uniformly finished and free of burrs, sharp edges, cracks, coarse marks, and processing materials. In addition, the forceps shall have handle serrations that are uniform in depth and spacing. Tests for hardness and corrosion resistance shall be performed and shall conform to the requirements specified.
SCOPE
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.

ABSTRACT
This terminology covers the general definitions of terms specific to stainless steel surgical suture needles.
SCOPE
1.1 This terminology covers general definitions for surgical needles.

ABSTRACT
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 are provided. Toxicity test, leakage test, and compatibility test shall be performed to meet the requirements prescribed.
SCOPE
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.

SCOPE
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.

ABSTRACT
This specification covers general workmanship and test method requirements of stainless steel suture needle holders intended for reuse in surgery. Materials of all component parts shall be fabricated from martensitic stainless steel type 410, 410X, 416, 420A, 420B, 420C, 420F, 420F Mod, and 440B. The material shall be heat treated and shall conform to the specified hardness, corrosion resistance, workmanship, finish, and appearance.
SCOPE
1.1 This specification covers general workmanship aspects of stainless steel suture needle holders intended for reuse in surgery.

SCOPE
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.

ABSTRACT
This specification covers the test methods and corresponding requirements for phase change-type disposable (for one time use only) clinical thermometers used for the intermittent determination of human temperature. When examined using the test methods suggested herein, sampled specimens shall comply with the specified requirements as to temperature range and graduation, accuracy, measurement retention, operating environment, storage environment, toxicity, workmanship, stability, and marking and labeling.
SCOPE
1.1 This specification covers phase change-type clinical thermometers that are designed and intended for one-time use.

ABSTRACT
This specification covers the requirements and test methods for direct-reading liquid crystal forehead thermometers, in either the continuous or intermittent reading modes, designed to monitor trends or measure human forehead surface temperatures, or both. When examined by test methods recommended herein, each thermometer shall comply with thermal profile, temperature range, tolerance, sequencing, operating and storage environment, and labeling requirements.
SCOPE
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.

ABSTRACT
This specification covers the general workmanship aspects of inserted and noninserted 410, 410K, 416, 420, 420A, and 420B martensitic stainless steel scissors intended for reuse in surgery. Inserts should be made of stellite, tungsten carbide, or other suitable materials. The instruments should conform to the required values of corrosion resistance cutting ability, Rockwell hardness, and physical properties after passivation and heat treatment. The products should also have finger rings, joints, cutting edges, pivot screws, and finish that are of the required quality.
SCOPE
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.

ABSTRACT
This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and intended for reuse in surgery. All of the component parts of the instruments shall be made of martensitic stainless steel of Type 410, 410X, 416, 416MOD, 420A, or 420B. Materials shall be tested and the individual grades shall conform to physical requirements such as heat treatment, hardness, and passivation; performance requirements such as finger rings, jaw serrations and teeth, box lock, clearance, ratchets, jaw and rachet setting, elasticity, and corrosion resistance. Workmanship, finish, and appearance, are also detailed.
SCOPE
1.1 This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and intended for reuse in surgery.

ABSTRACT
This specification covers electronic instruments intended for intermittent monitoring of patient temperatures. The temperature range of the instrument shall display temperature within the specific range requirement and regards to its accuracy, no individual reading shall be in error by more than the values that are determined. The operating environment must meet the determined accuracy requirements when operated in an environment of a certain temperature and also with a certain relative humidity. The resolutions of analog display such as Celsius graduations, Fahrenheit graduations, scale graduation marks and pointer width shall also be observed. Its digital display shall conform to the standard resolution, readability and battery condition of the material. The case material of the instrument and non disposable accessories shall withstand biological and physical cleaning without performance degradation. It shall also withstand dropping without presenting an electrical safety hazard. Those parts of the electronic thermometer system intended for contact with anatomical sites for the purpose of temperature measurement as specified by the manufacturer shall be also be nontoxic. The following tests shall be conducted in order to determine the instrument's performance: cleaning test, toxicity test, and accuracy test.
SCOPE
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 users of this standard to consult and establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SCOPE
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.

SCOPE
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.

ABSTRACT
This specification covers the dimensions and tolerances for both driving and driven elements in square drive interconnections on stainless steel surgical instruments used for drilling, tapping, driving, or placing of medical devices during surgery. The specification is intended to lessen the chance of accidental disengagement of surgical instruments.
SCOPE
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.

ABSTRACT
This terminology covers the general definitions of terms specific to stainless steel surgical suture needles.
SCOPE
1.1 This terminology covers general definitions for surgical needles.

ABSTRACT
This terminology covers the general definitions of terms specific to stainless steel surgical suture needles.
SCOPE
1.1 This terminology covers general definitions for surgical needles.

SCOPE
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.

ABSTRACT
This specification covers reusable phase-change-type clinical thermometers for determination of human temperature. The following test method shall be performed for performance verification: accuracy test; operating environment test; storage environment test; toxicity test (extract); toxicity test (chemical ingestion); and cleaning tests.
SCOPE
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.

SCOPE
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.

ABSTRACT
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. Clinical thermometers shall be classified as follows: basal metabolism or ovulation; multi-use with stubby bulb; oral; rectal; veterinary; and veterinary (heavy duty). The following tests shall be performed to conform to the specified requirements: retention of colorant; accuracy test; ease of resetting; temperature retention; fire cracks; and precision and bias.
SCOPE
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 and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
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 are provided. Toxicity test, leakage test, and compatibility test shall be performed to meet the requirements prescribed.
SCOPE
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 manufacturers instructions, the probe cover, sheath, and temperature measuring device shall remit correct temperature readings as required in Specifications E 667 and E 1112.

ABSTRACT
This specification covers infrared thermometers, which are electronic instruments intended for the intermittent measurement and monitoring of patient temperatures by means of detecting the intensity of thermal radiation between the subject of measurement and the sensor. The specification addresses the assessment of the subject's internal body temperature through measurement of thermal emission from the ear canal. Though, performance requirements for noncontact temperature measurement of skin are also provided. Limits are set for laboratory accuracy, and determination and disclosure of clinical accuracy of the covered instruments are required. Performance and storage limits under various environmental conditions, requirements for labeling, and test procedures are all established herein.
SCOPE
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.  
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.  
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.

ABSTRACT
This specification covers the test methods and corresponding requirements for phase change-type disposable (for one time use only) clinical thermometers used for the intermittent determination of human temperature. When examined using the test methods suggested herein, sampled specimens shall comply with the specified requirements as to temperature range and graduation, accuracy, measurement retention, operating environment, storage environment, toxicity, workmanship, stability, and marking and labeling.
SCOPE
1.1 This specification covers phase change-type clinical thermometers that are designed and intended for one time use.

SCOPE
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.

SCOPE
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.

ABSTRACT
This specification covers general workmanship requirements of spring-action, surgical tissue, dressing, or pick-up forceps (thumb type) for use in the retraction, grasping, or dissection of tissue during surgical procedures. However, this specification does not cover delicate tissue forceps such as employed in microsurgery or neurosurgery. The forceps and all component parts shall be manufactured from Class 4 martensitic stainless steel (heat treated), while modified working ends may be manufactured from stellite, tungsten carbide, or other suitable material. The forcep halves shall be symmetrical, with the teeth well formed, uniform in depth and spacing, and mesh without binding, and the surfaces uniformly finished and free of burrs, sharp edges, cracks, coarse marks, and processing materials. In addition, the forceps shall have handle serrations that are uniform in depth and spacing. Tests for hardness and corrosion resistance shall be performed and shall conform to the requirements specified.
SCOPE
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.

SCOPE
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.

SCOPE
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.

ABSTRACT
This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and intended for reuse in surgery. All of the component parts of the instruments shall be made of martensitic stainless steel of Type 410, 410X, 416, 416MOD, 420A, or 420B. Materials shall be tested and the individual grades shall conform to physical requirements such as heat treatment, hardness, and passivation; performance requirements such as finger rings, jaw serrations and teeth, box lock, clearance, ratchets, jaw and rachet setting, elasticity, and corrosion resistance. Workmanship, finish, and appearance, are also detailed.
SCOPE
1.1 This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and intended for reuse in surgery.

ABSTRACT
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. The stainless steels most used are martensitic and austenitic types. The instruments shall be used only for their intended purpose, such as cutting, holding, clamping, retracting, and so forth. Undue stress or strain should be avoided when handling and cleaning. The guide includes care in particular for hemostatic forceps, needle holders, scissors, microsurgical instruments, instrument kits, and other sharp instruments. The instrument care specified includes cleaning, lubrication, and inspection. Testing, repair and restoration, and sterilization are specified.
SCOPE
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.