定价： 3537元 / 折扣价： 3148 元 加购物车

定价： 1099元 / 折扣价： 979 元 加购物车

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

定价： 515元 加购物车

定价： 515元 加购物车

5.1 The specification is intended as a reference to the performance and safety of rubber surgical gloves. The safe and proper use of rubber surgical gloves is beyond the scope of this specification.AbstractThis specification covers certain requirements for packaged sterile rubber surgical gloves of the natural rubber latex type (Type 1) and of the synthetic rubber latex type (Type 2). The gloves shall be manufactured from any rubber polymer compound, with the inside and outside surfaces of the gloves free of talc and with dimensions and physical properties that shall conform to the requirements specified. Tests for sterility, freedom from holes, physical dimensions, tensile strength, ultimate elongation, stress at elongation, powder-free residue, powder amount, protein content, and antigenic protein content shall be performed to assess the conformance of the rubber gloves with the requirements specified.1.1 This specification covers certain requirements for packaged sterile rubber surgical gloves used in conducting surgical procedures.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.3 The following safety hazards caveat pertains only to the test method portion, Section 8, 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.

定价： 515元 加购物车

定价： 515元 加购物车

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.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.

定价： 515元 加购物车

3.1 This test method provides corrosion test methodologies and means of evaluation that serve as indicators of proper material selection and proper processing by the manufacturer.NOTE 1: It is recommended that instruments be chemically passivated according to one of the treatments in Specification A967, electropolished according to Specification B912, or both, prior to evaluating the corrosion resistance according to this test method. The likelihood of failure may be higher for non-passivated instruments.1.1 This test method covers general test procedures and evaluation criteria for the corrosion resistance of new and reusable surgical instruments fabricated from stainless steel alloys, such as, but not limited to, those listed in Specification F899.1.2 Instruments containing stainless steel materials that are exclusive to the following shall use the boil test and the copper sulfate test: austenitic materials (Class 3), precipitation hardening materials (Class 5), and ferritic materials (Class 6) containing equal or greater than 16 % chromium.1.3 Instruments containing any of the following stainless steel materials shall use the boil test: martensitic materials (Class 4) and ferritic materials (Class 6) containing less than 16 % chromium.1.4 The copper sulfate test is used to detect the presence of free iron on the surface of materials.1.5 The copper sulfate test as described in 6.2 is not recommended for martensitic materials or for ferritic materials containing less than 16% chromium because these steels may give a positive indication irrespective of the presence or absence of anodic surface contaminants (see X1.5).1.6 The boil test is applicable to martensitic, austenitic, ferritic, and precipitation hardening materials to detect surface imperfections, free iron, or other anodic surface contaminants on stainless steel.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 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.1.9 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： 515元 加购物车

定价： 515元 加购物车

定价： 515元 加购物车

定价： 481元 / 折扣价： 409 元 加购物车

This specification covers material requirements for chemical composition of anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and betatricalcium phosphate. Elemental analysis for calcium and phosphorus shall be consistent with the expected composition of the source of the biologically-derived bone mineral. X-ray diffraction analysis of the material shall be consistent with that specified for hydroxyapatite and calcium phosphate carbonate (carbonated apatite). The crystal size of the anorganic bone shall be determined from the X-ray diffraction data using the well-known Scherrer formula. The concentration of trace elements in the anorganic bone shall conform to the prescribed limit for: arsenic, cadmium, mercury, lead, and heavy metals (as lead), which may be determined by the following methods: inductively coupled plasma-mass spectroscopy (ICP-MS) or USP method and graphite furnace atomic absorption spectrophotometry. Organic content shall be measured either as total carbon or nitrogen or total protein by amino acid analyses. The carbonate content of the anorganic bone shall be determined. Functional groups shall be identified by infrared analysis. Requirements for biocompatibility and sterilization are given as well.1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix X1).1.2 The biological response to apatite in soft tissue and bone has been characterized by a history of clinical use and by laboratory studies (1, 2, 3).2 Xenogeneic bone, with organic components present, has been shown to be antigenic in the human host (4) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use (5, 6, 7).1.3 This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate.1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.5 Warning—Mercury has been designated by many regulatory agencies as a hazardous substance that can cause serious medical issues. Mercury, or its vapor, has been demonstrated to be hazardous to health and corrosive to materials. Use caution when handling mercury and mercury-containing products. See the applicable product Safety Data Sheet (SDS) for additional information. The potential exists that selling mercury or mercury-containing products, or both, is prohibited by local or national law. Users must determine legality of sales in their location.1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. (See Appendix X2).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.

定价： 515元 加购物车

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.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.

定价： 590元 加购物车

4.1 Materials and devices that function at least in part by adhering to living tissues are finding increasing use in surgical procedures, either as adjuncts to sutures and staples or as frank replacements for those devices in a wide variety of medical procedures. While the nature and magnitude of the forces involved varies greatly with indication and with patient specific circumstances, all uses involve, to some extent, the ability of the material to resist imposed mechanical forces. Therefore, the mechanical properties of the materials, and in particular the adhesive and cohesive properties, are important parameters in evaluating their fitness for use. In addition, the mechanical properties of a given sealant composition can provide a useful means of determining product consistency for quality control, or as a means for determining the effects of various surface treatments on the substrate prior to use of the device.4.2 The complexity and variety of individual applications for sealant, even within a single indicated use (surgical procedure), is such that the results of a burst test are not suitable for determining allowable design stresses without thorough analysis and understanding of the application and sealant behaviors.4.3 This test method may be used for comparing sealants for susceptibility to environmental changes, but such comparisons must be made with great caution since different sealants may respond differently to varying conditions.4.4 As the true sealant strength is strongly dependent on the strength of the sealant/substrate interface, the selection of a proper test substrate is critical. Care must be taken when extrapolating in vitro test results to in vivo expectations. In vitro sealant optimization may not translate to expected in vivo performance due to differences in substrate surface, strength, and elasticity.1.1 This test method provides a means for comparison of the burst or rupture strength of sealants on soft tissue. This test method can be used as a clinically relevant model for quality assurance, development, and comparative testing of different adhesives or adherends.1.2 This test method measures only burst strength or “cohesive strength” of an adhesive/adherend system, and not the adhesive strength.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 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 limitations prior to use.

定价： 590元 加购物车

1.1 This specification covers virgin polydioxanone homopolymer resins intended for use in surgical implants.1.2 Polydioxanone is commonly abbreviated as PDO, and is alternatively referred to as poly(para dioxanone) or poly(ρ-dioxanone) with the acronym PPD. Additionally, it may be referred to as PDS as it is the polymer of composition of PDS suture (Ethicon, Inc.), representing an early and widely used application of polydioxanone polymer.1.3 This specification covers virgin polydioxanone resins able to be fully solvated at 30 °C by fluorinated solvents such as hexafluoroisopropanol (HFIP) or hexafluoroacetone (HFA).1.4 Homopolymers of this composition are known to be semi-crystalline. Within this specification, semi-crystallinity within the resin is defined by the presence of a DSC (differential scanning calorimetry) crystalline endotherm peak upon annealing between 105 and 115 °C. While the presence of a crystalline endotherm indicates semi-crystallinity, the percentage and morphology of the crystalline phase are highly dependent on processing, and in particular on the thermal history of the material. Therefore, the thermal properties and percent crystallinity of the virgin polymer resin (with exception of melting temperature) are not necessarily indicative of final product quality.1.5 This specification addresses material characteristics of the virgin polydioxanone-based resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these materials, nor does it address the characteristics of polydioxanone resins with compounded materials such as dyes, polymeric or ceramic compounds, or any other additives.1.6 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated independently using appropriate test methods to ensure safety and efficacy.1.7 Biocompatibility testing is not a requirement since this specification is not intended to cover fabricated devices. While biocompatibility testing of resin may provide an early indication of potential safety, biocompatibility analysis of the final finished device is required to determine safety and suitability for any implant device. Refer to Supplementary Requirement S1 of this standard and Guide F2902 for relevant biocompatibility information.1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.10 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 590元 加购物车