C47 公共医疗设备 标准查询与下载
共找到 1175 条与 公共医疗设备 相关的标准，共 79 页
Systems for evacuation of plume generated by medical devices
- ICS
- 11.040.10
- CCS
- C47
- 发布
- 2014-05-31
- 实施
- 2014-05-31
Water treatment equipment for haemodialysis applications and related therapies
- ICS
- 11.040.20;11.040.40
- CCS
- C47
- 发布
- 2014-05-31
- 实施
- 2014-05-31
Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
- ICS
- 11.080.10
- CCS
- C47
- 发布
- 2014-05-31
- 实施
- 2014-05-31
Quality of dialysis fluid for haemodialysis and related therapies
- ICS
- 11.040.20;11.040.40
- CCS
- C47
- 发布
- 2014-05-31
- 实施
- 2014-05-31
Guidelines for older persons and persons with disabilities.Auditory guides in public space for mobility assist
- ICS
- 11.180.10
- CCS
- C47
- 发布
- 2014-05-20
- 实施
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2014-05-01
- 实施
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. 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. NOTE 3 For further information see ISO 1
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
- ICS
- 11.080.10
- CCS
- C47
- 发布
- 2014-05
- 实施
Le présent document apporte des précisions supplémentaires portant sur la source d'attente. Ont été modifiés les paragraphes suivants : 5.2 "Source d'alimentation en service", 5.3 "Source d'alimentation en attente", 5.4 "Source d'alimentation de secours", et 7.3 "Alarmes de contrôle de fonctionnement".
Oxygen concentrator supply systems for use with medical gas pipeline systems
- ICS
- 11.040.10
- CCS
- C47
- 发布
- 2014-03-26
- 实施
- 2014-03-26
Disinfection - Steam disinfection-apparatus - Part 4: Biological indicators for efficacy tests
- ICS
- 11.080.10
- CCS
- C47
- 发布
- 2014-03
- 实施
Wheelchairs. Batteries and chargers for powered wheelchairs
- ICS
- 11.180.10
- CCS
- C47
- 发布
- 2014-02-28
- 实施
- 2014-02-28
Health informatics. Categorial structures for representation of nursing diagnoses and nursing actions in terminological systems
- ICS
- 35.240.80
- CCS
- C47
- 发布
- 2014-02-28
- 实施
- 2014-02-28
Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2014-02-28
- 实施
- 2014-02-28
This part of BS 8599 specifies requirements for the compilation of first aid components in three sizes of first aid kits (small, medium and large) for use motor vehicles. Requirements are also given for the container holding the components.
First aid kits. Specification for the contents of motor vehicle first aid kits
- ICS
- 11.160;13.100
- CCS
- C47
- 发布
- 2014-01-31
- 实施
- 2014-01-31
Sterilization - Steam sterilizers - Part 7: Edificial preconditions, requirements for the services and the operation of steam sterilizers used in health care facilities
- ICS
- 11.080.10
- CCS
- C47
- 发布
- 2014-01
- 实施
Wheelchair seating - Part 11: Determination of perspiration dissipation characteristics of seat cushions intended to manage tissue integrity
- ICS
- 11.180.10
- CCS
- C47
- 发布
- 2014-01
- 实施
First aid material - First aid box B
- ICS
- 11.160
- CCS
- C47
- 发布
- 2014-01
- 实施
- 2014-01-01
Assistive products for persons with disability. Classification and terminology
- ICS
- 01.040.11;11.180.01
- CCS
- C47
- 发布
- 2014
- 实施
- 2016-01-01
YY/T 0567的本部分规定了关于经过无菌加工的医疗保健产品的制造过程的开发、确认和日常控制的流程、程序和执行步骤的一般要求以及指南。本部分涵盖关于整个无菌加工的总体要求和指南。其他部分则规定了关于过滤、冻干、在线清洗、在线灭菌和隔离系统的各种专用/专门流程和方法的特定要求及准则。
Aseptic processing of health care products.Part 1:General requirements
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2013-10-21
- 实施
- 2014-10-01
本标准提供了评价医疗保健产品(包括包装)的组成材料,包括高分子材料、金属、陶瓷/玻璃及其他材料对辐射灭菌加工的适宜性的程序和信息,为选择和鉴定医疗保健产品和包装的材料提供指南。
Evaluation of materials of health care product subject to radiation sterilization
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2013-10-21
- 实施
- 2014-10-01
