处理医疗材料用灭菌器和清洗消毒器检测

发布时间：2024-06-21 作者：中析研究所浏览：

NF C42-020-2-040-2015测量、控制和实验室用电气设备的安全要求.第2-040部分:处理医疗材料用灭菌器和清洗消毒器的特殊要求

Cet article de la Partie 1 est applicable, à l'exception de ce qui suit:

JS 61010-2-040-2010测量,控制和实验室用电气设备的安全要求.第2-040部分:处理医疗材料用灭菌器和清洗消毒器的详细要求

This Standard specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4. .

DIN 58946-7-2014消毒.蒸汽消毒器.第7部分:卫生设施中用蒸汽消毒器建造的先决条件、服务和操作要求

This standard specifies requirements and the appropriate tests for the installation of steam sterilizers and their supply of resources. It also includes requirements for the environmental conditions and for the operator in the sterilization of medical devices with moist heat. NOTE 1 Some places of this standard indicate to any requirements of specific product information on the installation and operation of steam sterilizers. NOTE 2 Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may apply to other products, devices and applications. Sections 5.2, 5.4 and 5.8 of this standard are not usually on small sterilizers in accordance with DIN EN 13060 apply. This standard supports the requirements of DIN EN ISO 17665-1. NOTE 3 DIN EN 285 and DIN EN 13060 requiremen technical requirements and requirements for carrying out the tests for steam sterilizers for use in health care facilities. This draft standard contains no requirements relating to occupational safety and safeguards of the sterilizer. It assumes, however, that are designed to operate such facilities available and operational. NOTE 4 Attention is drawn to the Medical Devices Operator Ordinance and the Ordinance on Industrial Safety. This draft standard contains no requirements for technical properties and the use of failure-detection systems. NOTE 5 At the present time no generally accepted performance criteria for failure-detection systems. failure-warning systems are in practice also been referred to as eg "Batch monitoring systems."

DIN 58949-2-2014消毒.蒸汽消毒装置.第2部分:要求

This standard applies to steam disinfection apparatus primarily used for medical purposes. It also applies to the steam disinfection of waste produced in public or private healthcare facilities, provided that this waste has to be specially treated in order to prevent infection, i. e. waste that has to be treated according to § 10a of the Federal Epidemics Act (BSeuchG) (so called waste of group C).

DIN EN 1422-2014医用灭菌器.环氧乙烷灭菌器.要求和试验方法;德文版本EN 1422-2014

This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories. This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for:

the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;

the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads. This European Standard does not specify those tests which are necessary to determine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in prEN ISO 11135:2012. This European Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities. NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations can exist. This European Standard does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber. NOTE 2 See EN ISO 14937. This European Standard is not intended as a checklist for suitability of an existing EO sterilizer when assessing compliance with prEN ISO 11135:2012. This standard is not intended to be applied retrospectively. This European Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products

DIN EN 14180-2014医用灭菌器.低温蒸汽和甲醛灭菌器.要求和试验.德文版本EN 14180-2014

This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. This European Standard specifies minimum requirements:

for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;

for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

DIN EN ISO 15883-1-2014清洗消毒器.第1部分:一般要求,术语,定义和试验(ISO 15883-1-2006+Amd 1-2014).德文版本EN ISO 15883-1-2009+A1-2014

This part of ISO 15883 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified.

DIN EN ISO 15883-6-2016清洗消毒器.第6部分:非侵入式,非关键医疗设备和保健设备用的利用热消毒的垫圈-消毒器具的试验和要求(ISO 15883-6-2011).德文版本EN ISO 15883-6-2015

This part of ISO 15883 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs. The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces). NOTE Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or combination of the two.

DIN EN ISO 17665-1-2006保健产品的灭菌.辐射.第1部分:医疗器件消毒过程的制定、确认和常规控制的要求(ISO 17665-1:2006)

1.1.1 This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.NOTE Although the scope of this part of ISO 17665 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products.1.1.2 Moist heat sterilization processes covered by this part of ISO 17665 include but are not limited to:a) saturated steam venting systems;b) saturated steam active air removal systems;c) air steam mixtures;d) water spray;e) water immersion. NOTE See also Annex E.

KS C IEC 61010-2-040-2018测量、控制和实验室用电气设备的安全要求.第2-040部分:处理医疗材料用灭菌器和清洗消毒器的特殊要求

1 적용범위와 목적n다음을 제외하고 제1부의 이 절을 적용할 수 있다:n1.1.1 범위에 포함되는 n장비n대체:n기존 텍스트를 다음으로 대체한다.n이 표준은 의학, 수의학, 제약 및 실험실 분야의 멸균, n세척 및 소독에 사용되는 전기장비를 1.4의 환경 조건에 따라 사용했을 때 안전성 요구사항을 규정한다.n이와 같은 장비의 예는 n다음을 포함한다:na) 증기 및/또는 온수를 살균제로 사용하는 멸균기와 소독기nb) 독성 가스, 독성 에어로솔 또는 독성 n증기를 살균제로 사용하는 멸균기와 소독기nc) 뜨거운 공기 또는 뜨거운 비활성 기체를 살균제로 사용하는 멸균기와 소독기 nd) n세척소독기