11.040.30 外科器械和材料 标准查询与下载
共找到 1266 条与 外科器械和材料 相关的标准，共 85 页
本文件规定了粘胶型石膏绷带(以下简称石膏绷带)的术语和定义、型式和规格、基本要求、技术要求、试验方法、检验规则、标签、说明书、包装、运输及贮存和质量承诺。 本文件适用于采用熟石膏、胶质材料、纱布等材料制成的粘胶型绷带（不含粉剂），主要用于矫形、骨折固定等。
Plaster of paris bandage-Viscose form
- ICS
- 11.040.30
- CCS
- C358
- 发布
- 2021-09-02
- 实施
- 2021-09-26
1.1?This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-12molybdenum-6zirconium-2iron alloy mill products to be used in the manufacture of surgical implants.2 1.2?The values stated in either SI units or inch-pound units are to
Standard Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120)
- ICS
- 11.040.30
- CCS
- 发布
- 2021-08-15
- 实施
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.
Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
- ICS
- 11.040.30
- CCS
- 发布
- 2021-07-01
- 实施
ISO 7153-1:2016 specifies metals commonly used to manufacture various types of standard surgical instruments, including but not limited to those used in general surgery, orthopaedics and dentistry. While ISO 7153-1:2016 is not intended for surgical instruments used in special applications, such as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.
Surgical instruments — Materials — Part 1: Metals
- ICS
- 11.040.30
- CCS
- 发布
- 2021-07-01
- 实施
This specification covers the acceptable material and dimensional requirements, and tolerances for bits of screwdrivers used for inserting and removing metal screws applied in surgical implants. The medical screwdrivers are available in the following types: Type I— single-slot bit; Type II— cruciate-slot bit; Type III— cross-slot (modified Phillips) bit; Type IV— hexagonal bit; Type V— square bit; Type VI— hexalobe bit. The bit and shaft portion should be fabricated from either martensitic stainless steel or cold worked cobalt-chromium-tungsten-nickel alloy, as specified. The portions should also meet specified values of Rockwell hardness.
Standard Specification for Medical Screwdriver Bits
- ICS
- 11.040.30
- CCS
- 发布
- 2021-07-01
- 实施
1.1 This test method describes the procedure for bend testing needles used for the placement of surgical sutures. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
- ICS
- 11.040.30
- CCS
- 发布
- 2021-07-01
- 实施
IEC 60601-2-2:2017 is also available as IEC 60601-2-2:2017 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-2-2:2017 applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories. HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements. The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories. This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - refinement and additions to the defined terms; - additional separation of the requirements for HF surgical equipment and HF surgical accessories; - a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes; - new requirements for devices that have or use a high current mode.
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- ICS
- 11.040.30
- CCS
- 发布
- 2021-07-01
- 实施
ISO 11810:2015 is applicable to disposable and reusable, as well as woven and non-woven materials used as surgical drapes and other patient-protective covers which claim to be laser-resistant. The purpose of this International Standard is to provide a standardized method for testing and classifying surgical drapes and other patient-protective covers with respect to laser-induced hazards. An appropriate classification system is given. It is not the purpose of this International Standard to serve as a general fire safety specification, and as such, this International Standard does not cover other sources of ignition. All materials reflect portions of the beam and it is necessary for the user to decide whether specular reflectance can be a hazard. This measurement, however, is not covered in this International Standard. The test procedure can be used to assess the laser induced flammability properties of non-laser-resistant items NOTE Users of products tested by this method are cautioned that the laser resistance of a surgical drape and/or patient-protective cover will be wavelength sensitive and that a surgical drape and/or patient-protective cover are better tested at the wavelength for which it is intended to be used. If tested using other wavelengths, it is necessary to explicitly state the power settings and modes of delivery.
Lasers and laser-related equipment — Test method and classification for the laser resistance of surgical drapes and/or patient protective covers — Primary ignition, penetration, flame spread and secondary ignition
- ICS
- 11.040.30
- CCS
- 发布
- 2021-07-01
- 实施
This specification covers the chemical requirements for wrought stainless steels used for the manufacture of surgical instruments. Classes of stainless steels covered here are Class 3 (austenitic stainless steel), Class 4 (martensitic stainless steel), Class 5 (precipitation hardening stainless steel), and Class 6 (ferritic stainless steel). The data contained in this specification, such as typical hardness values, common heat treating cycles, and examples of selected stainless steels that have been used for surgical instruments, are provided for reference only. Mechanical property, heat treatment, hardness, and all other requirements except for chemical composition, are governed by the appropriate material standards as specified or as agreed upon between purchaser and supplier.
Standard Specification for Wrought Stainless Steels for Surgical Instruments
- ICS
- 11.040.30
- CCS
- 发布
- 2021-07-01
- 实施
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.
Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods
- ICS
- 11.040.30
- CCS
- 发布
- 2021-07-01
- 实施
1.1 This test method covers general test procedures and evaluation criteria for the corrosion resistance of surgical instruments intended for reuse in surgery and fabricated from stainless steel such as, but not limited to, those listed in Specification F899. 1.2 Austenitic (Class 3), martensitic (Class 4), precipitation hardenable (Class 5), and ferritic (Class 6) materials shall use the boil test. 1.3 Ferritic (Class 6) materials with a minimum 16 % chromium content, austenitic (Class 3), and precipitation hardenable (Class 5) materials shall use the boil test and the copper sulfate test. 1.4 The copper sulfate test is used to detect the presence of metallic iron and iron oxide on the surface of materials. 1.5 The copper sulfate test is not recommended for martensitic materials. (See Note X1.1.) 1.6 The boil test is applicable to martensitic, austenitic, ferritic, and precipitation hardenable materials to detect free iron or any other anodic surface contaminants on stainless steel. 1.7 Values in either inch-pound or SI are to b
Standard Test Method for Corrosion of Surgical Instruments
- ICS
- 11.040.30
- CCS
- 发布
- 2021-07-01
- 实施
1.1?This specification covers ultra-high-molecular-weight polyethylene (UHMWPE) yarns intended for use in medical devices or components of medical devices, such as sutures and ligament fixations. This specification covers natural (non-colored) and pigmented (colored) yarns. 1.2
Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns
- ICS
- 11.040.30
- CCS
- 发布
- 2021-06-01
- 实施
This document specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This document also applies to instruments
Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021); German version EN ISO 16061:2021
- ICS
- 11.040.30
- CCS
- C31
- 发布
- 2021-06-00
- 实施
1.1?Consistent functionality of scaffolds used in TEMPs can be made more predictable by monitoring relevant characteristics related to physical and biological properties. This guide may be used in the selection of suitable test methods of dried ionically gelled alginate foam sca
Standard Guide for Testing and Characterization of Alginate Foam Scaffolds Used in Tissue-Engineered Medical Products (TEMPs)
- ICS
- 11.040.30
- CCS
- 发布
- 2021-05-15
- 实施
The aim of this standard is to determine dimensions that optimize the compatibility of instrument-side bipolar plugs with one another and thus ensure a secure connection to the corresponding socket parts of the HF cable.
Medical electrical devices - Dimensions of the plug connection between patient line and bipolar accessories
- ICS
- 11.040.30
- CCS
- K30
- 发布
- 2021-05-00
- 实施
- 2021-05-01
1.1?This practice covers recommended procedures for the handling of orthopedic implants and instruments. 1.2?Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instru
Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- ICS
- 11.040.30
- CCS
- 发布
- 2021-04-01
- 实施
Blood and pharmacy storage electric refrigerator and freezers
- ICS
- 11.040.30
- CCS
- 发布
- 20210329
- 实施
- 20210329
Method for determination of dosage added in disposable human venous blood sample collection containers Part 5: Glycine
- ICS
- 11.040.30
- CCS
- C31
- 发布
- 2021-03-09
- 实施
- 2022-04-01
Method for determination of dosage added in disposable human venous blood sample collection containers Part 6: Imidazolidinyl urea
- ICS
- 11.040.30
- CCS
- C31
- 发布
- 2021-03-09
- 实施
- 2022-04-01
