11.140 医院设备 标准查询与下载
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Standard Specification for Performance of Materials Used in Medical Face Masks
- ICS
- 11.140
- CCS
- 发布
- 2019-08-01
- 实施
1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare services such as surgery and patient care. 1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. 1.3 This specification does not address all aspects of medical face mask design and performance. This specification does not specifically evaluate the effectiveness of medical face mask designs as related to the barrier and breathability properties. This specification does not apply to regulated respiratory protection, which may be necessary for some healthcare services. 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 The following precautionary caveat pertains only to the test methods portion, Section 9, 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. 1.6 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 Performance of Materials Used in Medical Face Masks
- ICS
- 11.140
- CCS
- 发布
- 2019-08-01
- 实施
1.1 This test method is used to evaluate the resistance of materials used in protective clothing to synthetic blood under the conditions of liquid contact and increasing direct mechanical pressure. The penetration resistance of protective clothing is based on visual detection of synthetic blood penetration at a specific applied mechanical pressure. 1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for work/clothing exposure and assess the appropriateness of this test method for their specific application. 1.3 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing. This test method does not address the design, overall construction, components, or interfaces of garments, or other factors which may affect the overall protection offered by the protective clothing. 1.4 The values in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way. 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 Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Using a Mechanical Pressure Technique
- ICS
- 11.140
- CCS
- 发布
- 2019-05-01
- 实施
1.1 The methods herein specify two analytical tests for quantitatively evaluating surface bactericidal efficacy of medical examination gloves incorporated with bactericidal properties. They may be used for the determination of bactericidal activity on either the outer or inner glove surface. The methods incorporate bacterial challenges in two different formats: Method (A) a saline or buffered saline solution, and Method (B) a saline or buffered saline solution containing an organic load. Each method represents a different means of microbial contamination that can be expected in the healthcare environment. 1.2 Methods described herein are not appropriate for virucidal, fungicidal, tuberculocidal or sporicidal evaluations as each of these categories require unique culture techniques and testing conditions. Results of the test methods described in this document are limited to bactericidal efficacy against vegetative bacteria. 1.3 A more expansive glove description, such as broad spectrum antimicrobial efficacy, would require testing of a broader list of microbial species than vegetative bacteria alone. It is recommended that interested manufacturers discuss species and strain selections with appropriate regulatory agencies before testing is commenced. 1.4 Testing is to be performed by individuals trained in microbiological techniques under appropriate controlled conditions to ensure integrity of results and personnel safety. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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. Most regulatory agencies require compliance with Biocompatibility guidelines under ISO 10993. 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.
Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
- ICS
- 11.140
- CCS
- 发布
- 2019-05-01
- 实施
1.1 This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials. 1.2 This test method is a quantitative method that allows filtration efficiency for medical face mask materials to be determined. The maximum filtration efficiency that can be determined by this method is 99.9 %. 1.3 This test method does not apply to all forms or conditions of biological aerosol exposure. Users of the test method should review modes for worker exposure and assess the appropriateness of the method for their specific applications. 1.4 This test method evaluates medical face mask materials as an item of protective clothing but does not evaluate materials for regulatory approval as respirators. If respiratory protection for the wearer is needed, a NIOSH-certified respirator should be used. Relatively high bacterial filtration efficiency measurements for a particular medical face mask material does not ensure that the wearer will be protected from biological aerosols, since this test method primarily evaluates the performance of the composite materials used in the construction of the medical face mask and not its design, fit, or facial-sealing properties. 1.5 Units—The values stated in 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 nonconformance of the standard. 1.6 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask material. 1.7 This test method may also be used to measure the bacterial filtration efficiency (BFE) of other porous medical products such as surgical gowns, surgical drapes, and sterile barrier systems. 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.
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- ICS
- 11.140
- CCS
- /
- 发布
- 2019
- 实施
- 0000-00-00
1.1 This test method covers the detection of holes in medical gloves. 1.2 This test method is limited to the detection of holes that allow water leakage under the conditions of the test. 1.3 The smallest hole size that will allow water leakage in a medical glove has not been determined and is beyond the scope of this test method. 1.4 The safe and proper use of medical gloves is beyond the scope of this test method. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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. 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.
Standard Test Method for Detection of Holes in Medical Gloves
- ICS
- 11.140
- CCS
- /
- 发布
- 2019
- 实施
- 0000-00-00
1.1 This specification covers certain requirements for natural rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers natural rubber gloves used in handling contaminated medical material. 1.2 This specification provides for natural rubber gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile natural rubber gloves and packaged or bulk nonsterile natural rubber gloves. 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.
Standard Specification for Rubber Examination Gloves
- ICS
- 11.140
- CCS
- /
- 发布
- 2019
- 实施
- 0000-00-00
1.1 This practice covers a protocol for the assessment of resistance of medical glove materials to permeation by potentially hazardous cancer chemotherapy drugs under conditions of continuous contact. An assessment is made based on the permeation (breakthrough) of nine chemotherapy drugs through the glove material over a certain period of time. 1.2 It is emphasized that the conditions used in this assessment are intended to approximate the worst-case condition for clinical uses. The data should be restricted to use on a relative basis when comparing glove materials. 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, 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.
Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
- ICS
- 11.140
- CCS
- /
- 发布
- 2019
- 实施
- 0000-00-00
Disposable medical gloves Part 4: Puncture resistance test methods
- ICS
- 11.140
- CCS
- C48
- 发布
- 2018-12-20
- 实施
- 2020-01-01
Specifications for setting up vaccination clinics
- ICS
- 11.140
- CCS
- C 00
- 发布
- 2018-11-28
- 实施
- 2019-05-28
Standard Guide for Assessment of Medical Gloves
- ICS
- 11.140
- CCS
- 发布
- 2018-11-01
- 实施
This Standard applies to the basic safety and essential performance of medical beds, hereafter referred to as medical beds as defined in 201.3.218, intended for children as defined in 201.3.207, and adults with atypical anatomy (adults ranging outside the definition for adults in 201.3.201).
Medical electrical equipment - Particular requirements for the basic safety and essential performance of medical beds for children; German version EN 50637:2017
- ICS
- 11.140
- CCS
- 发布
- 2018-07-01
- 实施
- 2018-07-01
1.1 This specification covers certain requirements for natural rubber (Latex), synthetic rubber (Polychloroprene and Nitrile), and vinyl (PVC) disposable gloves for use in conducting single-use embalming procedures. 1.2 This specification covers natural rubber (Latex), synthetic rubber (Polychloroprene and Nitrile), and Vinyl (PVC) disposable gloves that fit either hand, paired gloves, gloves by size, and gloves packed in bulk. 1.3 An assessment to measure the chemical resistance performance of the glove can be made based on the ultimate permeation (breakthrough) of embalming chemicals through the glove material over a specified period of time. 1.4 This specification is similar to the following specifications: D3578, D4679, D5250, D6319, and D6977. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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. 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.
Standard Specification for Disposable Embalming Gloves for Single-Use Applications
- ICS
- 11.140
- CCS
- 发布
- 2018-06-01
- 实施
本标准提出了全科型乡镇卫生院的应具备基本条件，并对其药品的配置标准、药品储存及管理做了相应的规定，最后对全科型乡镇卫生院的环境卫生、信息化管理、人员配置、档案管理也提供了相应的规范。
Standards for the storage and configuration of Medicines in Comprehensive-type Township Hospitals
- ICS
- 11.140
- CCS
- Q841
- 发布
- 2018-04-25
- 实施
- 2018-05-24
为了规范全科型乡镇卫生院药品采购与配送环节的管理，保障人体用药安全、有效，制定本标准。本标准适用于全科型乡镇卫生院药品采购与配送环节的质量管理。本标准规定了药品采购技术、药品的配送管理及药品的验收管理规定。
Standards for the Procurement and Distribution of Medicines in Comprehensive-type Township Hospitals
- ICS
- 11.140
- CCS
- Q841
- 发布
- 2018-04-25
- 实施
- 2018-05-24
Safety requirements of electrical installations for medically used rooms in hospitals and clinics
- ICS
- 11.140
- CCS
- C37
- 发布
- 2018-01-22
- 实施
Standard Guide for Fire Hazard Assessment of the Effect of Upholstered Seating Furniture Within Patient Rooms of Health Care Facilities
- ICS
- 11.140
- CCS
- 发布
- 2017-12-15
- 实施
Technical specification for biosafety cabinet testing
- ICS
- 11.140
- CCS
- C 48
- 发布
- 2017-12-08
- 实施
- 2018-05-08
Medical electrical equipment. Particular requirements for the basic safety and essential performance of medical beds for children
- ICS
- 11.140
- CCS
- 发布
- 2017-11-28
- 实施
- 2017-11-30
Medical electrical equipment - Particular requirements for the basic safety and essential performance of medical beds for children
- ICS
- 11.140
- CCS
- 发布
- 2017-11-01
- 实施
