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ANSI/AAMI ST58-2013 医疗保健设施中戊二醛基产品的安全使用和处理

This recommended practice provides guidelines for the selection and use of liquid chemical sterilants (LCSs)/high-level disinfectants (HLDs) and gaseous chemical sterilizers that have been cleared for marketing by the U.S. Food and Drug Administration for use in hospitals and other health care facilities. Included within the scope of this recommended practice are functional and physical design criteria for chemical sterilization and high-level disinfection processing areas; staff qualifications, education, and other personnel considerations; criteria for selecting LCSs/HLDs and gaseous chemical sterilizers; safety and efficacy considerations in the use of LCSs/HLDs and gaseous chemical sterilizers; preparation of devices for processing by chemical sterilization or high-level disinfection; quality control methods; and quality process improvement. Definitions of terms and informative annexes are also provided.

Chemical sterilization and high-level disinfection in health care facilities

ICS
CCS: C04
发布: 2013-08-21
实施

NF S98-103-2:2013 保健产品的灭菌.辐射.第2部分:确定杀菌剂量

Sterilization of health care products - Radiation - Part 2: establishing the sterilization dose

ICS: 11.080.99
CCS: C04
发布: 2013-08-03
实施: 2013-08-03

ISO 11137-1:2006/Amd 1:2013 保健产品的灭菌.辐射.第1部分:医疗器械灭菌过程的制定、确认、和常规控制的要求.修改件1

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; Amendment 1

ICS: 11.080.01
CCS: C04
发布: 2013-07-15
实施

BS CWA 16642:2013 医疗保健服务. 健康检查质量标准

Health care services. Quality criteria for health check

ICS: 11.020
CCS: C04
发布: 2013-06-12
实施: 2013-06-12

ISO 11137-2:2013 保健产品的灭菌.辐射.第2部分:杀菌剂量的确定

This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

ICS: 11.080.01;11.080.99
CCS: C04
发布: 2013-06-01
实施

JIS T 0701:2013 接触镜.词汇和分类系统

Contact lenses -- Vocabulary and classification system

ICS: 01.040.11;11.040.70
CCS: C04
发布: 2013-03-01
实施

ASTM E1174-13 评价医护人员洗手液配方有效性的标准试验方法

5.1 The procedure may be used to test the effectiveness of antimicrobial handwashing agents. The test formulations may be designed for frequent use to reduce the transient bacterial flora on hands. Alcohol-based hand rubs and other leave-on formulations used without the aid of water may be tested using Test Method E2755. 1.1 This test method is designed to determine the effectiveness of antimicrobial handwashing agents for the reduction of transient microbial flora when used in a handwashing procedure. 1.2 A knowledge of microbiological techniques is required for these procedures. 1.3 This test method may be used to evaluate topical antimicrobial handwash formulations. 1.4 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects.2 1.5 The values stated in SI units are to be regarded as standard; except for distance, in which case inches are used and metric units follow in parentheses. 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 and health practices and determine the applicability of regulatory limitations prior to use. For more specific precautionary statements see 8.2.

Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations

ICS: 71.100.40 (Surface active agents)
CCS: C04
发布: 2013
实施

NF S92-060*NF EN ISO 15189:2012 医学实验室.质量和能力的要求

La présente Norme internationale spécifie les exigences de qualité et de compétence applicables aux laboratoires de biologie médicale.La présente Norme internationale s'adresse aux laboratoires de biologie médicale qui élaborent leurs systèmes de management de la qualité et évaluent leur propre compétence. Les clients des laboratoires, les autorités règlementaires ainsi que les organismes d'accréditation engagés dans des activités de confirmation ou de reconnaissance de la compétence des laboratoires de biologie médicale peuvent également s'y référer.La présente Norme internationale n'est pas destinée à des fins de certification des laboratoires.

Medical laboratories - Requirements for quality and competence