定价： 345元 / 折扣价： 294 元 加购物车

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.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.

定价： 515元 / 折扣价： 438 元 加购物车

5.1 Approximately 650,000 primary total knee arthroplasties (TKAs) and 50,000 revision TKAs are performed in the United States annually (7, 8). There are between 100,000 and 200,000 anterior cruciate ligament knee injuries per year in the United States (9).1.1 This guide is intended as a resource for individuals and organizations when designing clinical trials and/or clinical registries and addresses the selection of patient-reported outcomes, safety outcomes, imaging outcomes and other topics related to knee reconstructive surgery (KRS) including: (1) knee replacement systems, (2) anterior cruciate ligament reconstruction, (3) knee meniscus implants or tissue engineered medical products (TEMPs), (4) articular cartilage implants or TEMPS, (5) peri-articular knee osteotomies, (6) peri-articular knee fractures (including distal femur, patella, and proximal tibia fractures), or other knee surgeries.1.2 In this guide, methods to measure the efficacy, effectiveness, and safety of KRS devices through standardizing clinical outcome measures are provided for designing, reviewing, and accepting human clinical trial protocols.1.3 This guide is intended to provide consistency in study design, review, regulatory approval, and health insurance coverage approval for knee reconstructive surgery to the health care market.1.4 For the purpose of this guide, KRS pertains to any device or TEMP that is intended to replace, resurface, reconstruct, and/or provide fixation of the knee joint, in part or in total, as a treatment for joint disease, trauma, or dysfunction, where long-term improvement in function and pain relief without major adverse events are the desired outcomes.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 590元 / 折扣价： 502 元 加购物车

5.1 Approximately 500 000 primary total hip arthroplasties (THAs) and 66 000 revision THAs are predicted to be performed in the United States in 2020 (7). There are an estimated 340 000 hip fractures per year in the United States (8).1.1 This guide is intended as a resource for individuals and organizations when designing clinical trials and/or clinical registries and addresses the selection of patient-reported outcomes, safety outcomes, imaging outcomes, and other topics related to hip reconstructive surgery (HRS) including: (1) hip replacement systems, (2) hip fracture surgery, (3) acetabular fracture surgery, (4) hip arthroscopy and/or labrum repairs, and (5) peri-acetabular osteotomies, or other hip surgeries.1.2 In this guide, methods to measure the efficacy, effectiveness, and safety of HRS devices through standardizing clinical outcome measures are provided for designing, reviewing, and accepting human clinical trial protocols.1.3 This guide is intended to provide consistency in study design, review, regulatory approval, and health insurance coverage approval for hip reconstructive surgery to the health care market.1.4 For the purpose of this guide, HRS pertains to any device or tissue-engineered medical product (TEMP) that is intended to replace, resurface, reconstruct, and/or provide fixation of the hip joint, in part or in total, as a treatment for joint disease, trauma, or dysfunction, where long-term improvement in function and pain relief without major adverse events are the desired outcomes.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 590元 / 折扣价： 502 元 加购物车

4.1 This guide is aimed at providing a range of in vivo models to aid in pre-clinical research and development of tissue-engineered medical products (TEMPs) intended for the clinical repair or regeneration of bone in the spine.4.2 This guide includes a description of the animal models, surgical considerations, and tissue processing as well as the qualitative and quantitative analysis of tissue specimens.4.3 The user is encouraged to utilize appropriate ASTM and other guidelines to conduct cytotoxicity and biocompatibility tests on materials, TEMPs, or both, prior to assessment of the in vivo models described herein.4.4 It is recommended that safety testing be in accordance with the provisions of the FDA Good Laboratory Practices Regulations 21 CFR 58.4.5 Safety and effectiveness studies to support regulatory submissions (for example, Investigational Device Exemption (IDE), Premarket Approval (PMA), 510K, Investigational New Drug (IND), or Biologics License Application (BLA) submissions in the U.S.) should conform to appropriate guidelines of the regulatory bodies for development of medical devices, biologics, or drugs.4.6 Animal model outcomes are not necessarily predictive of human results and should, therefore, be interpreted cautiously with respect to potential applicability to human conditions.1.1 This guide covers general guidelines for the pre-clinical in vivo assessment of tissue-engineered medical products (TEMPs) intended to repair or regenerate bone in an interbody and/or posterolateral spinal environment. TEMPs included in this guide may be composed of, but are not limited to, natural or synthetic biomaterials or composites thereof, and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, or cDNA. The models described in this document represent a stringent test of a material’s ability to induce and/or augment bone growth in the spinal environment.1.2 While clinically TEMPs may be combined with hardware for initial stabilization or other purposes, the focus of this guide is on the appropriateness of the animal model chosen and evaluation of the TEMP-induced repair and as such does not focus on issues of components or constructs.1.3 Guidelines include a description and rationale of various animal models for the in vivo assessment of the TEMP. The animal models utilize a range of species including rat (murine), rabbit (lapine), dog (canine), goat (caprine), pig (porcine), sheep (ovine), and non-human primate (primates). Outcome measures include in vivo assessments based on radiographic, histologic, and CT imaging as well as subsequent in vitro assessments of the repair, including histologic analyses and mechanical testing. All methods are described briefly and referenced. The user should refer to specific test methods for additional detail.1.4 This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of the product. ASTM standards for these steps are available in Referenced Documents (Section 2).1.5 The use of any of the methods included in this guide may not produce a result that is consistent with clinical performance in one or more specific applications.1.6 Other pre-clinical methods may also be appropriate, and this guide is not meant to exclude such methods. The material must be suitable for its intended purpose. Additional biological testing in this regard would be required.1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.8 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.1.9 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.

定价： 918元 / 折扣价： 781 元 加购物车

3.1 This practice pertains to all forms of toxicological testing (acute, subchronic, or chronic) performed by any route of administration (inhalation, oral, dermal, ocular, or other).3.2 The U.S. Environmental Protection Agency, Good Laboratory Practices for Nonclinical Laboratory Studies, as listed in 40 CFR, requires that a testing facility maintain specific standard operating procedures (SOPs) including an SOP covering clinical observations in test animals.3.3 This practice serves as a basis for consistency in clinical observations and is not meant to serve as a comprehensive list of observations that may be observed. Actual procedures and forms to be used in recording observations must be described in individual study protocols.1.1 This practice describes the terms used in observing and recording cutaneous, gastrointestinal, respiratory, reproductive, neuromuscular, ocular, and general clinical signs of animals undergoing toxicological testing. This practice also assists in properly observing and assessing laboratory animals for signs of disease or adverse effects of compound administration.1.2 This practice includes codes and descriptions for a wide variety of clinical signs, anatomical locations, and other descriptive qualifiers, and a technique for scoring the extent or severity of clinical signs.1.3 This practice assumes that the reader is knowledgeable in animal toxicology and related pertinent areas and is trained in making clinical observations.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.

定价： 590元 / 折扣价： 502 元 加购物车

4.1 Clinical PDD examinations refer to the employment of polygraph instrumentation for the purpose of detecting deception or verifying truthfulness of statements of individuals under court supervision, or in treatment for the commission of a sex offense.4.2 Clinical PDD examinations are specifically intended to assist in the detection, treatment, or supervision of sex offenders.4.3 Clinical PDD testing should be regarded as a decision-support tool intended to assist professionals in making important decisions regarding risk and safety assessments. Clinical PDD testing should not replace the need for other forms of behavioral monitoring or traditional forms of supervision and field investigations.1.1 This guide establishes procedures for conducting a clinical polygraph examination (CPE), to include, but not limited to, post conviction sex offender testing (PCSOT). This PDD model is specifically intended to assist in the treatment and supervision of sex offenders on probation, parole, or a deferred prosecution alternative.1.2 This guide also applies to the conduct of clinical polygraph examinations for therapeutic purposes when requested by a presiding legal authority.1.3 This guide directs that such examiners for this application are specifically trained in issues associated with supervision and treatment of sex offenders.

定价： 0元 / 折扣价： 0 元

1 Scope This part of ISO 5841 specifies requirements for reports on the clinical performance in humans of population samples of pulse generators or leads, intended for long-term implantation as cardiac pacemakers, hereinafter referred to as devices. It

定价： 683元 / 折扣价： 581 元

5.1 Magnetic resonance imaging is ideally suited to image MOM hip arthroplasty due to its superior soft tissue contrast, multiplanar capabilities and lack of ionizing radiation. MR imaging is the most accurate imaging modality for the assessment of peri-prosthetic osteolysis and wear-induced synovitis (19, 20).5.2 Before scanning a patient with a specific implant, the MR practitioner shall confirm that the device is MR Conditional and that the scan protocol to be used satisfies the conditions for safe scanning for the specific implant.5.3 This guide can be used to identify the following adverse events.5.3.1 Osteolysis—Magnetic resonance imaging is superior to conventional radiographs and computer tomography (CT) in the assessment of peri-prosthetic osteolysis and has been shown to be the most accurate method to locate and quantify the extent of peri-prosthetic osteolysis (19, 21). On MR imaging, osteolysis appears as well marginated intraosseous intermediate to slightly increased signal intensity lesions that contrast with the high signal intensity of the intramedullary fat. A characteristic line of low signal intensity surrounds the area of focal marrow replacement, distinguishing the appearance of osteolysis from tumoral replacement of bone or infection (22).FIG. 4 Coronal (left) and Axial (right) FSE Images of a Left MOM Hip ArthroplastyNOTE 1: There is focal osteolysis (white arrows) in the greater trochanter, which manifests as well-demarcated intermediate signal intensity, similar to that of skeletal muscle, replacing the normal high signal intensity fatty marrow. Images courtesy of Dr. Hollis Potter.5.3.2 Component Loosening—While the data are preliminary, MR imaging can identify circumferential bone resorption that may indicate component loosening. Loosening may result from osteolysis, circumferential fibrous membrane formation or poor osseous integration of a non-cemented component. On MR imaging, component loosening typically manifests as circumferential increased signal intensity at the metallic-bone or cement-bone interface on fat-suppressed techniques (20). The finding of circumferential fibrous membrane formation or osteolysis also indicates potential loosening; this is in contrast to a well-fixed component, with high signal intensity fatty marrow directly opposed to the implant interface.5.3.3 Wear-Induced Synovitis—Magnetic resonance imaging is the most useful imaging modality to assess the intracapsular burden of wear-induced synovitis surrounding MOM arthroplasty (23). Preliminary data indicate that the signal characteristics of the synovial response on MR imaging correlate with the type of wear-induced synovitis demonstrated on histology at revision surgery (24). Low signal intensity debris is suggestive of metallic debris on histology. Mixed intermediate and low signal debris correlate with the presence of mixed polymeric (polyethylene and/or polymethyl methacrylate) and metallic debris at histology. Magnetic resonance imaging can demonstrate decompression of synovitis or fluid into adjacent bursae, such as the iliopsoas or trochanteric bursa, which can present as soft tissue masses or with secondary nerve compression. On occasion, wear-induced synovitis can result in a chronic indolent pattern of erosion of the surrounding bone, even in the absence of focal osteolytic lesions (6).FIG. 5 Axial (left) and Coronal (right) FSE Images of a Left MOM Hip ArthroplastyNOTE 1: Wear-induced synovitis decompresses into the abductor musculature where there is low signal intensity debris (arrow), consistent with metallic debris. Images courtesy of Dr. Hollis Potter.5.3.4 Infection—In the setting of infection, the synovium often demonstrates a hyperintense, lamellated appearance with adjacent extracapsular soft tissue edema. These appearances help to distinguish the synovial pattern of infection from wear-induced synovitis, although aspiration is still required for definitive diagnosis (22). The presence of a soft tissue collection, draining sinus or osteomyelitis further supports the diagnosis of infection on MR imaging.FIG. 6 Axial FSE (left) and Inversion Recovery (right) Images of a Right MOM Hip AthroplastyNOTE 1: There is a lamellated synovitis (black arrow) with adjacent extracapsular soft tissue edema (white arrow). Infection was confirmed at subsequent aspiration. Images courtesy of Dr. Hollis Potter.5.3.5 Adverse Local Tissue Response—Adverse local tissue reactions can manifest as synovitis, bursitis, osteolysis and cystic or solid masses adjacent to the arthroplasty, which may be termed pseudotumors (19, 20). ALTR can also include the histopathologic feature of aseptic lymphocytic vasculitis-associated lesions (ALVAL), which can be confirmed at histology. A relatively common appearance of joints with ALVAL is expansion of the capsule with homogenous high signal fluid interspersed with intermediate signal intensity foci. More recent studies suggest that maximum synovial thickness and the presence of more solid synovial deposits highly correlate with tissue damage at revision surgery and necrosis at histologic inspection (15).FIG. 7 Axial FSE Image in a Right MOM Hip ArthroplastyNOTE 1: Fig. 7 demonstrates a large collection of fluid in the trochanteric bursa (arrow), which communicates with the hip joint via a dehiscence in the posterior pseudocapsule (not shown in these images). The fluid is high signal with fine intermediate signal intensity debris. A high ALVAL score was confirmed on histology at revision surgery. Images courtesy of Dr. Hollis Potter.FIG. 8 Axial FSE Image in a Right MOM Hip Resurfacing ArthroplastyNOTE 1: Fig. 8 demonstrates expansion of the pseudocapsule with fluid signal intensity decompressing into the trochanteric bursa. The pseudocapsule is thickened and of intermediate signal intensity (black arrows). There is additional solid extracapsular disease anteriorly (white arrow). At revision surgery, a mixed picture of ALVAL and metallosis was seen.5.3.6 Modular Taper Associated ALTR—MRI can accurately describe ALTR attributed to tribocorrosion in modular femoral neck total hip arthroplasty. MRI characteristics, particularly maximal synovial thickness and synovitis volume, can predict histologic severity (22, 23). In addition, intra-capsular ALTR around either resurfacing MOM arthroplasty or around the trunnion in MOM THA may be obscured if 3D-MSI techniques are not utilized due to the susceptibility artifact. High-bandwidth FSE or FSE with view-angle tilt are not sufficient.NOTE 1: Modular taper ALTR may occur in non-metal-on-metal implants as well as in metal-on-metal arthroplasty.1.1 This guide describes the recommended protocol for magnetic resonance imaging (MRI) studies of patients implanted with metal-on-metal (MOM) devices to determine if the periprosthetic tissues are likely to be associated with an adverse local tissue reaction (ALTR). Before scanning a patient with a specific implant, the MR practitioner shall confirm that the device is MR Conditional and that the scan protocol to be used satisfies the conditions for safe scanning for the specific implant. This guide assumes that the MRI protocol will be applied to MOM devices while they are implanted inside the body. It is also expected that standardized MRI safety measures will be followed during the performance of this scan protocol.1.2 This guide covers the clinical evaluation of the tissues surrounding MOM hip replacement devices in patients using MRI. This guide is applicable to both total and resurfacing MOM hip systems.1.3 The protocol contained in this guide applies to whole body magnetic resonance equipment, as defined in section 201.3.239 of IEC 60601-2-33, Ed. 3.2, with a whole body radiofrequency (RF) transmit coil as defined in section 201.3.240. The RF coil should have circulary polarized RF excitation (also commonly referred to as quadrature excitation) as defined in section 201.3.249 of IEC 60601-2-33, Ed. 3.2..1.4 The values stated in SI units are to be regarded as standard.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. The user may consider all precautions and warnings provided in the MR system and hip implant labeling prior to determining the applicability of these protocols.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.

定价： 646元 / 折扣价： 550 元 加购物车

4.1 This practice uses clinical radiographs of the hip joint of a patient that has received a total hip replacement to measure the combined effect of plastic deformation and wear at the articular interface which results in three-dimensional displacements of the femoral head into the acetabular component.4.2 This practice addresses the validation of the various computational methods available for measuring the magnitude of creep/wear accruing at the articular surface of THRs.4.3 This practice addresses the type of radiographic projections needed for an analysis as well as general radiographic parameters needed for obtaining high quality films.4.4 This practice addresses the criterion for evaluating clinical radiographs for inclusion in a study.4.5 This practice addresses the conversion of radiographic images to the appropriate digital format needed for the various computer-assisted computational methods.1.1 This practice provides guidance for the measurement of the relative displacement of the femoral head and acetabular component that result from wear and deformation occurring at the articular interface of a total hip replacement from sequential clinical radiographs.1.2 This practice is primarily intended for use in evaluating patients receiving THRs composed of a polyethylene acetabular component articulating against a metal or ceramic femoral head.1.3 So-called hard-on-hard articulations such as metal-on-metal and ceramic-on-ceramic THRs are not intended to be directly addressed.1.4 This practice will focus on computer-assisted computational methodologies for measuring relative displacements over time but not to the exclusion of other methodologies.1.5 This practice describes methods for conducting a radiographic wear/creep study utilizing various computational methods and is not intended to promote or endorse a particular method.1.6 It is not the intent of this practice to provide detailed instructions in the use of the various computational methods, which is contained in the respective user manuals.1.7 It is the intent of this practice to enable comparisons of relative displacements occurring in groups of patients receiving different formulations of bearing materials. It must be recognized, however, that there are many possible variations in the in vivo conditions. A single clinical study may not be universally representative.1.8 This practice is not intended to be a performance standard. It is the responsibility of the user of this practice to characterize the safety and effectiveness of the prosthesis under evaluation.1.9 The values stated in SI units are to be regarded as the standard, with the exception of angular measurements, which may be reported in either degrees or radians. Additionally, pixel density may also be reported in imperial units.1.10 The use of this standard may involve the operation of potentially hazardous radiographic equipment and does not purport to address the safety precautions associated with radiography. It is the responsibility of the user of this standard to define and establish appropriate safety practices. The standard does not determine the applicability of regulatory limitations prior to operating radiographic equipment.1.11 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.1.12 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.

定价： 590元 / 折扣价： 502 元 加购物车

5.1 Approximately 300,000 primary total hip arthroplasties (THAs) and 50,000 revision THAs are performed in the United States annually (5, 6). In addition, approximately 50 % of the 300,000 hip fractures in the United States annually are femoral neck fractures. The majority of femoral neck fractures are treated with hip hemiarthroplasties (femoral head replacement only).1.1 This guide is intended as a resource for individuals and organizations involved in designing clinical trials of hip replacement systems (HRSs) including metal/polymer, metal/metal, metal/composite, metal/ceramic/polymer, metal/polymer/metal, and ceramic/ceramic bearing surfaces; semi-constrained and constrained designs; and cemented, nonporous uncemented, and porous-coated uncemented fixation.1.2 In this guide, methods to measure the efficacy, effectiveness, and safety of HRS devices through standardizing outcomes measures are provided for designing, reviewing, and accepting human clinical trial protocols.1.3 This guide is intended to provide consistency in study design, review, regulatory approval, and coverage approval for hip replacement systems to the health care market.1.4 For the purpose of this guide, an HRS is any device that is intended to replace the hip joint, in part or in total, as a treatment for joint disease, trauma, or dysfunction, where long-term functional restoration and pain relief without major adverse events are the desired outcomes.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

定价： 0元 / 折扣价： 0 元

This specification defines an electronic representation that includes the varying information required for broad exchange in health care both today and in the future. eXtensible Markup Language (XML) is a convergence of data processing, communication, and publishing technology. XML is a platform, vendor, and application independent technology for describing document content and structure in tags or elements. The names of the tags and the rules for using them are contained in the document type definition (DTD). The clinical XML DTD defines the standard XML DTD for: admission notes, discharge summaries, history and physical examinations, operative reports, pathology reports, radiology reports, and radiation therapy summaries. The DTDs define templates for clinical content. Clinical content may take the form of character data or elements from the XHTML Basic 1.0 DTD.1.1 This specification defines an electronic representation that includes the varying information required for broad exchange in health care both today and in the future. eXtensible Markup Language (XML) is a convergence of data processing, communication, and publishing technology. XML is a platform, vendor, and application independent technology for describing document content and structure in tags or elements. The names of the tags and the rules for using them are contained in the Document Type Definition (DTD). The DTD describes the structure of the document and defines the names of tags it contains. Additionally the DTD declares the order in which the tags occur and how often the tags can appear; that is, the DTD defines the hierarchy of the tags. A DTD for a prescription might contain structural elements for the medication prescribed medication>, the dosage dosage>, the form form>, the quantity quantity>, and so forth. This specification is in the form of a set of standard XML DTDs that match the electronic document requirements in the health care industry.1.2 This specification refers to and makes use of recommendations from the World Wide Web consortium, the W3C (http://www.w3.org).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 requirements prior to use.

定价： 0元 / 折扣价： 0 元

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.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.

定价： 0元 / 折扣价： 0 元

This specification updates a standard representation for storing and organizing the heterogeneous information contained in clinical practice guidelines, intended to facilitate translation of natural-language guideline documents into a format that can be processed by computers. This specification is based on the guideline elements model version 2 (GEM II) created at the Yale Center for Medical Informatics by health services researchers and informatics specialists, and designed to serve as a comprehensive XML-based guideline document representation.1.1 This specification updates a standard representation for storing and organizing the heterogeneous information contained in clinical practice guidelines. This specification is intended to facilitate translation of natural-language guideline documents into a format that can be processed by computers. It can be used to represent document content throughout the entire guideline life cycle. Information at both high and low levels of abstraction can be accommodated. This specification is based on the guideline elements model (GEM) created at the Yale Center for Medical Informatics and designed to serve as a comprehensive XML-based guideline document representation.1.2 This specification refers to and makes use of recommendations from the World Wide Web consortium, the W3C.1.3 Standard Guideline Schema—This specification defines a standard Schema for clinical practice guidelines. The Schema is included in Annex A1.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

定价： 0元 / 折扣价： 0 元