11.040.30 外科器械和材料 标准查询与下载
共找到 1261 条与 外科器械和材料 相关的标准，共 85 页
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
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
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
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
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
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
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
Blastocyst cell staining and counting methods for medical devices used in human assisted reproductive technology
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2021-03-09
- 实施
- 2022-04-01
Endoscopic surgical instruments reusable abdominal puncture set
- ICS
- 11.040.30
- CCS
- C36
- 发布
- 2021-03-09
- 实施
- 2022-04-01
1.1 This specification covers the acceptable dimensions and tolerances for bits of screwdrivers to insert and remove metal screws used as surgical implants. 1.2 This specification is based, in part, upon ISO 8319-1, ISO 8319-2, and ISO 10664. 1.3 The screwdrivers with the bits described in this specification are suitable for use with screws described in Specification F543, ISO 5835, and ISO 9268. 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 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.
Standard Specification for Medical Screwdriver Bits
- ICS
- 11.040.30
- CCS
- 发布
- 2021-02-01
- 实施
The project defines dimensions and marking of retractors type Volkmann, as used in surgery and public health service.
Medical instruments - Retractor type Volkmann
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2021-02-00
- 实施
