定价： 345元 / 折扣价： 294 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

定价： 646元 / 折扣价： 550 元 加购物车

定价： 590元 / 折扣价： 502 元 加购物车

定价： 0元 / 折扣价： 0 元 加购物车

定价： 590元 / 折扣价： 502 元 加购物车

定价： 590元 / 折扣价： 502 元 加购物车

定价： 0元 / 折扣价： 0 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

定价： 918元 / 折扣价： 781 元 加购物车

定价： 515元 / 折扣价： 438 元 加购物车

定价： 0元 / 折扣价： 0 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

定价： 0元 / 折扣价： 0 元 加购物车