【国外标准】 Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors
本网站 发布时间:
2024-02-28
开通会员免费在线看70000余条国内标准,赠送文本下载次数,单本最低仅合13.3元!还可享标准出版进度查询、定制跟踪推送、标准查新等超多特权!  
查看详情>>
标准简介
适用范围:
4.1 Significance—Dried blood represents a significant challenge to cleaning surgical instruments. The water-soluble components of blood are easily rendered insoluble when exposed to heat, chemical solutions, or time at room temperature. The water insoluble component of blood is fibrin built up during coagulation. These proteins bind quite readily to the surfaces of surgical instruments making them difficult to remove even with the aid of chemical cleaning agents. Instruments contaminated with blood residue after reprocessing represent a significant threat for infection to healthcare workers and patients. Healthcare facilities typically employ the use of automated instrument washers. These devices combine mechanical action along with chemical cleaning agents in a staged cleaning cycle designed to thoroughly clean surgical instruments. To function properly, these machines must be performing at targeted mechanical efficiency and deliver the correct chemical cleaning agents at the correct temperature, at the correct dosage for the correct period of time. Manufacturers of automated washers and manufacturers of cleaning detergent need to evaluate the performance of their products utilizing a surrogate for surgical instruments soiled with blood. The results of the performance testing will be used to improve product design and for validation of the performance of their product for various regulatory requirements.4.2 Use—The regular, periodic use of the blood soil test is a systemic challenge to the functioning of an automated washer. To properly challenge the cleaning device, the test must be analogous to the dried blood soil, to the stainless steel substrate, and to the physical barriers presented by surgical instruments. These physical barriers include the box lock, or pivot joint of a hinged instrument, the serrated tips, and crevices of surgical instruments. On the test coupon, the components of blood are similar to the state of dried blood on instruments. By utilizing a grooved stainless steel coupon, the substrate is similar to that of stainless steel instruments. By mounting the soiled coupon in a plastic holder the physical barriers represented by cracks and crevices of instruments (for example, box locks) are represented. Users are provided with an interpretation guide that aids them in interpreting results that are less than optimal. For instance, failure to remove the fibrin layer of blood soil (which is water insoluble) indicates a problem with the chemical cleaning agent(s). Failure to evenly remove a hemoglobin soil indicates a mechanical failure. Failure to remove any soil indicates either a catastrophic mechanical failure, or inappropriate settings for the initial rinse stage. As a standardized challenge, the test provides a reproducible means for the washer manufacturer and the detergent manufacturer to compare new designs and formulations to those existing within their own product line as well as those of others in the market. For the purpose of submitting their instructions for use, the test provides a means to validate the performance of their product with a device that is a surrogate for the devices their products will be used to clean in the practical setting. This validation testing can be used as part of any necessary documentation for regulatory filings and records.1.1 This guide is based on a standardized test soil correlating to coagulated blood suitable for screening tests and the evaluation of the cleaning efficiency of washer-disinfectors used for reprocessing of surgical instruments. This guide strictly deals with cleaning and does not describe any methods that are related to disinfection. See Referenced Documents D5343, D4008, D4265, D2960, and D3050 in Section 2 for additional information.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 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.
标准号:
ASTM D7225-13(2019)e1
标准名称:
Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors
英文名称:
Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors标准状态:
Active-
发布日期:
-
实施日期:
出版语种:
- 其它标准
- 上一篇: ASTM D7224-23 Standard Test Method for Determining Water Separation Characteristics of Kerosine-Type Aviation Turbine Fuels Containing Additives by Portable Separometer
- 下一篇: ASTM D7226-13(2023) Standard Test Method for Determining the Viscosity of Emulsified Asphalts Using a Rotational Paddle Viscometer
- 推荐标准
- 国家标准计划
- 24/30491443 DC standard
- 24/30489392 DC BS EN IEC 62358 Ferrite cores. Standard inductance factor for gapped cores and its tolerance
- BS ISO 19848:2024 - TC Tracked Changes. Ships and marine technology. Standard data for shipboard machinery and equipment
- BS ISO 19848:2024 Ships and marine technology. Standard data for shipboard machinery and equipment
- 24/30487130 DC BS EN 50566:2017/A2:2024 Product standard to demonstrate the compliance of wireless communication
- BS IEC 61360-7:2024 Standard data element types with associated classification scheme
- 24/30486472 DC - Product standard
- KS M ISO 4259-4 석유 및 관련 제품 — 측정 방법과 결과의 정밀도 — 제4부: 개별 실험실에서 표준 시험방법의 실행에 대한 ‘통계적 관리’ 상태를 확인하기 위한 통계적 관리도의 사용
- KS C IEC 61340-4-7 정전기학 — 제4-7부: 구체적 적용 분야에 대한 표준 시험방법 — 이온화
- KS C IEC 61340-4-8 정전기학 — 제4-8부: 구체적 적용 분야에 대한 표준 시험방법 — ESD 차폐성 — 봉투
- KS C IEC 61340-4-6 정전기학 — 제4-6부: 구체적 적용 분야에 대한 표준 시험방법 — 손목접지대
- 24/30485973 DC standard
- BS EN 14662-1:2023 - TC Tracked Changes. Ambient air quality. Standard method for measurement of benzene concentrations
- KS C IEC 61837-2 주파수 제어 및 선택을 위한 표면 실장형 압전 장치 — 표준 아웃라인 및 단자 리드 연결 — 제2부: 세라믹 함체
- 24/30485462 DC BS EN IEC 61753-1 Fibre optic interconnecting devices and passive components - Performance standard